- Email: [email protected]
Thermachoice endometrial ablation in the outpatient setting, without local anesthesia or intravenous sedation: A prospective cohort study
Thermachoice endometrial ablation in the outpatient setting, without local anesthesia or intravenous sedation: a prospective cohort study Fiona Marsh, M.B.B.S., M.R.C.O.G., Jenny Thewlis, R.G.N., B.Sc., and Sean Duffy, M.D., F.R.C.O.G., F.R.C.S. St. James’s University Hospital, Leeds, United Kingdom
Objective: To determine whether Thermachoice endometrial ablation (EA) is a safe and acceptable procedure when performed in the outpatient (OP) setting without local anesthesia or IV sedation. Design: Prospective cohort (double group) study. Setting: Hysteroscopy clinic of large UK hospital. Patient(s): Twenty-seven women with menorrhagia. Intervention(s): The first cohort of women underwent Thermachoice EA without elective analgesia. The second cohort underwent Thermachoice after taking ibuprofen. Main Outcome Measure(s): To map pain scores and the requirement of “rescue analgesia.” To assess speed of recovery and time away from home. Result(s): Thermachoice EA was successfully performed in the OP setting on 89% (n ⫽ 24) of women. Four women in the first cohort required rescue analgesia compared to none in the second. During the procedure there was little difference between the groups visual analogue style pain scores—with the overall score being 3.6 (range ⫽ 0 –10). Postoperatively there was a lower mean pain score in the second cohort, with fewer women experiencing nausea and vomiting. Mean time away from home was 2.6 hours and mean time to make a full recovery was 3.3 days. Women required analgesia for 2.6 days, on average, and returned to their normal activities at this time. Conclusion(s): Thermachoice EA without local analgesia or IV sedation can be safely and successfully performed in the OP setting and if ibuprofen is taken preoperatively few women require “rescue analgesia.” (Fertil Steril威 2005;83:715–20. ©2005 by American Society for Reproductive Medicine.) Key Words: Endometrial ablation, outpatient, analgesia, anesthesia, menorrhagia
During the past 10 –15 years advances in daycase investigations and treatments have changed the way in which gynecological services are delivered in the United Kingdom. The Department of Health’s National Health Service plan aims to “further transfer inpatient care to daycase or ambulatory (outpatient) care thus reducing the length of hospital stay and shortening waiting times” (1).
There is now evidence to suggest that, if given a choice, women would prefer hysteroscopy to be performed in the OP setting as opposed to under general anesthesia (3). A randomized controlled trial comparing the cost of OP and DC hysteroscopy has shown a significant and considerable cost saving to the woman, her employer, and the NHS if the hysteroscopy is performed in the OP setting (4).
The role of outpatient (OP) diagnostic procedures is well established in gynecological practice. Hysteroscopy in the OP setting is now replacing daycase (DC) hysteroscopy under general anesthetia, as the investigation of choice for women with abnormal uterine bleeding.
Having established the role of diagnostic procedures, our unit has undertaken studies to investigate the potential benefits of therapeutic hysteroscopic procedures in the OP setting. Hysteroscopic polypectomy and hysteroscopic sterilization are currently being performed in this hospital without elective analgesia in the OP setting. Women are given the option of having “rescue” analgesia should they require it. These OP therapeutic procedures have been well tolerated and are acceptable to women (5).
When OP hysteroscopy, awake and without analgesia, was compared in a randomized controlled trial, to DC hysteroscopy patients had a reduced hospital stay, less time off work, and an earlier return to full mobility and fitness (2). Received April 16, 2004; revised and accepted August 26, 2004. Presented in poster format at the 12th Annual Congress of the European Society for Gynaecological Endoscopy, Luxembourg, November 26 – 29, 2003. Reprints requests: Dr. Fiona Marsh, Academic Department of Obstetrics and Gynaecology, University of Leeds, Level 9, Gledhow Wing, St. James’s University Hospital, Beckett Street, Leeds, LS9 7TF, United Kingdom (FAX: 0113-234-3450; E-mail: [email protected]).
0015-0282/05/$30.00 doi:10.1016/j.fertnstert.2004.08.030
Thermal balloon endometrial ablation (EA) using “Thermachoice” is another such therapeutic procedure. Thermachoice is a second-generation ablative technique that lends itself to OP treatment due to the thin (4.5 mm) diameter of the catheter. We performed Thermachoice EA, in the OP setting, without local anesthesia or IV sedation, on two cohorts of women
Fertility and Sterility姞 Vol. 83, No. 3, March 2005 Copyright ©2005 American Society for Reproductive Medicine, Published by Elsevier Inc.
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with menorrhagia. This study aimed to determine whether Thermachoice EA is a safe and acceptable procedure when performed in the OP setting. MATERIALS AND METHODS Twenty-seven women with menorrhagia were recruited from the gynecology clinic of a large UK teaching hospital. All women had menorrhagia for at least the previous 6 months. For the purpose of this study menorrhagia was defined as excessive or prolonged menstrual flow, which is unacceptable to the patient. All women were counseled about the risks of Thermachoice EA including uterine perforation, infection, and pregnancy. All women in our study had completed their families and did not want a future pregnancy. They were given advice, if necessary, regarding contraception. Additional inclusion criteria were: a normal endometrial sample and scan or hysteroscopy within the preceding 6 months, negative cervical cytology within the preceding 3 years, and written informed consent. Exclusion criteria consisted of women with submucus fibroids, polyps, or premalignant lesions; a uterine cavity length of ⬎12 cm; pregnancy; pelvic inflammatory disease (PID) within the preceding 6 months; latex allergy; previous EA; myomectomy or classic cesarean section; and abnormal uterine bleeding of unknown cause. The primary objectives were to determine whether Thermachoice EA without local analgesia or intravenous sedation can be safely and successfully performed in the OP setting. The secondary objectives were to map visual analogue pain scores at different stages of the procedure; to determine the requirement for postoperative analgesia; to assess the speed of recovery and to assess time away from home. Thermachoice EA was performed in the “OP Hysteroscopy” room within the Daycase Unit. All facilities were available for resuscitation and patients had the use of a fully staffed recovery ward should they require it.
nate the treatment. Uterine contractions, which cause dysmenorrhoea and pelvic cramping, are believed to be caused by prostaglandins (6). The nonsteroidal anti-inflammatory drug ibuprofen has been shown to be the most effective anti-prostaglandins at treating dysmenorrhoea, with a low incidence of side effects (7). Ibuprofen has also been shown to reduce the resting pressure (P⬍.001), active pressure (P⬍.001), and frequency of cyclic activity of the nonpregnant uterus as well as menstrual pain (8). The second cohort of women underwent Thermachoice EA after taking elective ibuprofen. They were prescribed three ibuprofen 600-mg tablets preoperatively. They were asked to take one tablet at 10 PM the evening before treatment, one tablet 1 hour before treatment (as the peak serum concentration occurs after 60 –90 minutes), and one tablet 4 hours after the treatment. All women in the study had the option of receiving “rescue” analgesia in the form of nitrous oxide (inhaled), tramadol (50 –100 mg orally), or morphine sulfate (10 mg IM), should they require it. They were assured that, if at any stage they asked to stop the procedure, their request would be immediately respected and acted upon. Women were fully counseled about Thermachoice EA both verbally and with an information leaflet several weeks before undergoing the procedure. They were warned that they might experience “period type” cramp both during and after the procedure. One operator (FM) performed all the Thermachoice procedures. Data Collection Exactly the same prospective data were collected from both the first and second cohorts to allow for comparison. This included information on patient’s characteristics and operating details.
The first cohort of women underwent Thermachoice without elective analgesia (i.e., awake in the OP setting with no premedication, IV sedation, or local anesthetic).
To quantify the pain intensity experienced in the two cohorts of women, we opted to use a one-dimensional tool, the visual analogue scale (VAS). The VAS has been found to be a valid, reliable, and reproducible means of assessing pain (9). It is particularly useful for the setting of acute pain and is best used for the sequential evaluation of pain allowing for statistical analysis (10). Women were asked to place a vertical mark, using a slide rule, on a 100-mm horizontal VAS bounded by the descriptors “no pain” on the far left and “worst possible pain” on the far right. A VAS score was recorded at regular intervals (Fig. 1) throughout and after the procedure. One week after treatment women were asked to complete an “Assessment of Recovery” form, which included details of the length of time it took the woman to return to her normal activities, and how long she required postoperative analgesia.
Having mapped the pain scores and discussed the nature of the pain, we established that uterine cramping both during and after Thermachoice was most commonly responsible for women requiring “rescue” analgesia or requesting to termi-
Thermachoice Endometrial Ablation—The Procedure The Thermachoice I uterine balloon therapy system consists of a 16-cm long by 4.5-mm diameter catheter with a latex
Ethical Committee consent (Institutional Review Board approved) was obtained before recruitment into this study. There is currently no published data mapping pain scores during Thermachoice in the OP setting. Nor is there any information on the requirement of “rescue” analgesia or whether or not elective analgesia reduces discomfort during or after the procedure. We therefore planned to undertake this study in two phases.
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Outpatient Thermachoice endometrial ablation
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FIGURE 1 Mean visual analogue scale (VAS) pain scores during Thermachoice and postoperatively.
Marsh. Outpatient Thermachoice endometrial ablation. Fertil Steril 2005.
balloon at its distal end—this houses a heating element. The controller unit monitors, displays, and controls preset intraballoon pressure, temperature, and duration of treatment. For safety, the device automatically deactivates when the pressure falls below 45 mm Hg or rises above 200 mm Hg. After pelvic examination a Cuscoe’s speculum was passed vaginally to visualize the cervix. If necessary the cervical canal was dilated to 5 mm and the length of the uterine cavity was assessed with a “sound.” The Thermachoice balloon and catheter was inserted into the uterine cavity and filled with 5% dextrose, thus allowing the balloon to expand to fit the size and shape of the uterus. Intrauterine pressures of 160 –180 mm Hg were maintained at a temperature of 87°C for 8 minutes. When the treatment cycle was complete, all of the fluid was withdrawn from the balloon and the balloon and catheter were removed. RESULTS Patient’s characteristics and operative details are presented in Table 1. Our groups were matched for age, previous vaginal delivery, and number of women requiring cervical dilation. The cohort of women who underwent Thermachoice without elective analgesia is described as the first cohort, whereas those who took preoperative ibuprofen are described as the second cohort. Fertility and Sterility姞
Three women in this study had never had a vaginal delivery. One was nulliparous and the other two had undergone cesarean sections. Thermachoice EA was successfully performed in all three of these women in the OP setting. However, there were two women (one in each group) whose procedures were abandoned, because we were unable to dilate the cervical canal. Thermachoice was abandoned in another patient in the first group after 3 minutes, 36 seconds, at her request, as she experienced severe pelvic cramping pain. Figure 1 shows the VAS pain scores for both cohorts of women during and after Thermachoice was performed. During the procedure (i.e., up to and including the 8-minute mark in Fig. 1), there was little difference between the cohorts with regard to VAS pain scores—with the overall pain score being 3.6. One of the most uncomfortable parts of the procedure for both cohorts of women was the insertion of the Thermachoice catheter, with average pain score for all women of 4.2. The VAS pain scores for the first cohort of women gradually increased during the procedure from the attainment of a temperature of 87°C to the end of the treatment at 8 minutes. These women described the discomfort as cramping pelvic pain and several required “rescue” analgesia (Table 2). 717
TABLE 1 Patient characteristics and operative details.
Mean age (y) Mean duration of menorrhagia (y) Previous vaginal delivery Mean uterine cavity length (cm) Mean volume of dextrose required to inflate balloon to desired pressure (mL) No. of women requiring cervical dilation Successful 8-minute treatment
First cohort (n ⴝ 14)
Second cohort (n ⴝ 13)
40.9 7.0 86% (n ⫽ 12) 8.3 10.2
43.5 6.6 92% (n ⫽ 12) 8.5 10.3
50% (n ⫽ 7) 86% (n ⫽ 12)
69% (n ⫽ 9) 92% (n ⫽ 12)
The procedure was abandoned in two women (one from each group) due to failure to dilate the cervix. Another woman in the first group asked for the procedure to be stopped after 3 minutes 36 seconds due to pelvic cramping pain. P ⫽ not significant. Marsh. Outpatient Thermachoice endometrial ablation. Fertil Steril 2005.
The mean VAS pain scores for the second cohort of women peaked at the 4-minute mark (4.2) and then, in contrast to the first cohort, steadily decreased throughout the treatment and was at its lowest (1.4) after treatment. These women again complained of pelvic cramping pain; however, this was less severe than in the first cohort. Two hours after the Thermachoice procedure, the first cohort reported their highest average VAS pain score of 5.4, compared to 3.6 for the second cohort. There were four women in the first group who required “rescue” analgesia (Table 2). Three of these women had both nitrous oxide during the procedure and tramadol (100 mg orally) immediately after the procedure. One of these women went on to require morphine (10 mg) and Prochlorperazinetil (12.5 mg IM). Another woman declined intraoperative analgesia but requested tramadol (100 mg) postoperatively. There were no women in the second cohort who requested “rescue” analgesia. Similarly fewer women in the second cohort experienced nausea and vomiting after the treatment (Table 2). Thus, although ibuprofen provides no reduction in VAS pain scores initially, it does appear to reduce cramping pelvic pain during the latter half of treatment and after the procedure. Ibuprofen also appears to lessen the requirement for rescue analgesia and reduce nausea and vomiting rates.
Women who successfully underwent Thermachoice EA were asked whether they would recommend the treatment to a friend and whether they would opt to have the procedure performed in the OP setting in the future were they to require it again. Ninety-two percent of women replied and they all said they would recommend Thermachoice EA, performed in the OP setting, to a friend. Seventy-seven percent said that they would have the procedure performed in the OP setting again if they were to require it in the future. Table 3 contains data on the speed of women’s recovery and the amount of time they were away from their home to have the treatment performed. DISCUSSION Thermachoice EA without local analgesia or IV sedation can be safely and successfully performed in the OP setting. We successfully performed a full 8-minute treatment on 89% (n ⫽ 24/27) of women in the OP setting and there were no intra- or postoperative complications in this study. This is the first time that VAS pain scores have been mapped throughout Thermachoice EA in the OP setting. Our results show that during Thermachoice treatment the VAS scores are low, with an average score for both cohorts being
TABLE 2 Assessment of rescue analgesia requirement and nausea and vomiting rates.
Requirement for rescue analgesia Nausea Vomiting
First cohort (n ⴝ 14)
Second cohort (n ⴝ 13)
P value
33% (n ⫽ 4/12) 42% (n ⫽ 5/12) 25% (n ⫽ 3/12)
0% (n ⫽ 0) 8% (n ⫽ 1/12) 8% (n ⫽ 1/12)
.028 .059 NS
Marsh. Outpatient Thermachoice endometrial ablation. Fertil Steril 2005.
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TABLE 3 Assessment of recovery.
Mean Mean Mean Mean
time time time time
First group (n ⴝ 14)
95% confidence interval (range)
Second group (n ⴝ 13)
95% confidence interval (range)
3.9 2.6 2.8 2.6
(1.8–6) (1.3–3.9) (1.6–3) (2.2–3)
2.8 2.7 2.7 2.6
(1.6–4) (1.3–4.1) (1.3–4.1) (2.1–3.1)
to full recovery (days) pain relief required (days) to return to normal activities (days) away from home (hours)
P ⫽ not significant. Marsh. Outpatient Thermachoice endometrial ablation. Fertil Steril 2005.
3.6. One of the most uncomfortable parts of the treatment (for all women regardless of cohort) was the insertion of the Thermachoice catheter with an average VAS score of 4.2. Unsurprisingly ibuprofen had no advantageous effect on either this score or the discomfort felt when inserting the uterine sound. This is probably because the pain experienced at this stage is due to dilatation of the cervical canal. However, these pain scores compare favorably to those experienced by women when inserting an intrauterine coil device (IUCD). A randomized controlled trial by D’Souza et al. (11) compared the acceptability of frameless intrauterine coil device (IUCD) to a plastic T-framed IUCD. The mean VAS pain scores (0 –10) at insertion of these devices were 5.7 and 4.8, respectively. The introduction of ibuprofen significantly reduced the number of women who required “rescue” analgesia both during and after the treatment. The only woman who asked to stop the treatment despite “rescue” analgesia was in the first cohort. All women who had preoperative ibuprofen completed the treatment and experienced less nausea and vomiting than the group who had no elective analgesia. After the Thermachoice procedure there was also a lower mean pain score in the ibuprofen group at both 30 minutes and 2 hours after treatment. In view of these advantages we have continued to prescribe preoperative ibuprofen to women undergoing Thermachoice EA in the OP setting. The safety and efficacy of Thermachoice is well established; however, the vast majority have been performed under general anesthesia with the inherent risks and side effects involved. There have been a small number of studies looking at Thermachoice under local anesthetia and it appears to be well tolerated by patients. However, the role of local anesthesia in the reduction of pain for OP gynecological procedures has not been confirmed. Fernandez et al. (12) performed Thermachoice on 18 patients in the OP setting under local anesthesia. They gave ketoprofen or paracetomol preoperatively followed by a paracervical block with 20 mL of 1% lignocaine (with epinephrine1:200,000). An additional 20 mL of 1% lignocaine was injected into the endoFertility and Sterility姞
cervical canal, isthmus and uterocervical ligaments. The mean VAS pain scales (0 –10) during the procedure in the Fernandez et al. study were 3.8, which is similar to the mean VAS pain score in this study of 3.6. These findings once again question the beneficial role of local anesthesia in OP gynecological procedures. Several studies have been reported looking at the role of local anesthesia in OP hysteroscopy. Paracervical and intracervical lignocaine have been shown to be as painful as the hysteroscopy itself and do not reduce the discomfort felt during the procedure (13–15). Paracervical block has the added risk of intravasation and severe side effects have been reported (16). Likewise, studies comparing lignocaine gel and lignocaine spray to placebo have shown no significant difference when assessing pain (17, 18). Thus there is evidence to suggest that local anesthesia does not appear to improve the success rate or reduce discomfort when performing OP gynecological procedures and it can be painful and potentially dangerous. In several other studies of Thermachoice in the OP setting women were given IV sedation such as midazolam, fentanyl, and propofol (19). There are several disadvantages to IV sedation including the risk of respiratory depression and increased need for resuscitative measures. In a study by Duggan and Dodd (19) using IV sedation they concluded that the additional observations required to ensure safe administration of intraoperative sedation probably preclude balloon ablation as a suitable office procedure. Thus there is no evidence to support the use of either local anesthesia or IV sedation in the OP setting. This study shows that women from both cohorts were, on average, away from their homes for only 2.5 hours to have Thermachoice treatment. This study also found that women were returning to their normal activities within 2–3 days. Most people would agree that less time forgone from normal activities has an important value to the woman, her family, her employer, and society as a whole. 719
An increasing number of diagnostic and therapeutic procedures are being performed in the OP setting and offer many advantages to both the woman and the NHS. Ambulatory therapy not only expedites treatment, thus reducing waiting lists, but also provides cost savings to the women, her employer, and the NHS (4). Furthermore, the avoidance of general anesthesia in women with coexistent medical morbidity means that OP treatment should be safer in this higher risk group. The Department of Health’s NHS plan aims to promote “treatments which are shown to be clinically and costeffective” and “shape these treatments around the convenience and concerns of patients” (1). Thermachoice EA in the OP setting offers several benefits over performing Thermachoice in the DC setting, not least the avoidance of general anesthetia and its associated risks. It also obviates the need for an anesthetist and operating theater staff and resources. Therefore, Thermachoice EA in the OP setting not only provides potential clinical advantages to the woman but also cost savings to both her and the health service. To verify this, a randomized controlled trial comparing OP and daycase, Thermachoice needs to be undertaken to determine differences in patient acceptability, pain scores, complication rates, recovery time, time away from home, and cost to the woman, her employer, and the health service. In conclusion, Thermachoice EA without local analgesia or IV sedation can be safely and successfully performed in the OP setting. If ibuprofen is taken preoperatively it appears that very few women require any form of rescue analgesia. Thermachoice EA in the OP setting offers potential clinical advantages and cost savings to the woman and the health service. REFERENCES 1. NHS. The NHS Plan. Department of Health. www.doh.co.uk. 2. Kremer C, Duffy S, Moroney M. Patient satisfaction with outpatient hysteroscopy versus day case hysteroscopy: randomised controlled trial. Brit Med J 2000;320:282–3.
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3. Marsh FA, Taylor L, Kremer C, Duffy S. Delivering an effective outpatient service in gynaecology. An assessment of patients’ preference. Gynaecol Endosc 2002;1:337– 43. 4. Marsh FA, Kremer SD, Duffy S. Delivering an effective outpatient service in gynaecology. A randomised controlled trial analysing the cost of outpatient versus daycase hysteroscopy. BJOG 2004; 111:243– 8. 5. Rogerson L, Hudson H, Duffy S. UK Experience using the ESSURE micro-insert for hysteroscopic sterilisation. Rev Gynaecolo Pract 2003; 3:1– 4. 6. Furniss LD. Nonsteroidal anti-inflammatory agents in the treatment of primary dysmenorrhoea. Clin Pharm 1982;1:327–33. 7. Zhang WY, Li Wan Po A. Efficacy of minor analgesics in primary dysmenorrhoea: a systematic review. BJOG 1998;105:780 –9. 8. Pulkkinen MO, Csapo AI. The effect of ibuprofen on the intrauterine pressure and menstrual pain of dysmenorrheic patients. Prostaglandins 1978;15:1055– 62. 9. Kendall H, Spence J, Murphy M. Review of pain measurement tools. Ann Emerg Med 1996;27:427–32. 10. Gallagher E, Lieban M, Bijur, P. Prospective validation of clinically important changes in pain severity measured on a visual analogue scale. Ann Emerg Med 2001;38:633– 8. 11. D’Souza R, Masters T, Bounds W, Guillebaud J. Randomised controlled trial assessing the acceptability of Gynefix versus Gyne-T380S for emergency contraception. J Fam Plan Reprod Health Care 2003; 29:23–9. 12. Fernandez H, Capella S, Audibert F. Uterine thermal balloon therapy under local anaesthesia for the treatment of menorrhagia. Hum Reprod 1997;12:2511– 4. 13. Lau WC, Lo WK Tam WH, Yeun PM. Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. BJOG 1999;106:356 –9. 14. Vercellini P, Colombo A, Mauro F, Oldani S, Bramante T, Crosignani PG. Paracervical anaesthesia for outpatient hysteroscopy. Fertil Steril 1994;5:1083–5. 15. Broadbent JA, Hill NC, Molnar BG, Rolfe KJ, Magos AL. Randomised placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. BJOG 1992;99:777– 80. 16. Mercado AO, Naz JF, Ataya KM. Postabortal paracervical block abscess as a complication of paracervical block anaesthesia. A case report. J Reprod Med 1989;34:247–9. 17. Clark S, Vonau B, Macdonald R. Topical anaesthesia in outpatient hysteroscopy. Gynae Endosc 1996;5:141– 4. 18. Davies A, Richardson RE, O’Connor H, Baskett TF, Nagele F, Magos AL. Lignocaine aerosol spray in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. Fertil Steril 1997;97:1019 –23. 19. Duggan PM, Dodd J. Endometrial balloon ablation under local analgesia and intravenous sedation. Aust NZ J Obstet Gynaecol 1999;39: 123– 6.
Outpatient Thermachoice endometrial ablation
Vol. 83, No. 3, March 2005
Objective: To determine whether Thermachoice endometrial ablation (EA) is a safe and acceptable procedure when performed in the outpatient (OP) setting without local anesthesia or IV sedation. Design: Prospective cohort (double group) study. Setting: Hysteroscopy clinic of large UK hospital. Patient(s): Twenty-seven women with menorrhagia. Intervention(s): The first cohort of women underwent Thermachoice EA without elective analgesia. The second cohort underwent Thermachoice after taking ibuprofen. Main Outcome Measure(s): To map pain scores and the requirement of “rescue analgesia.” To assess speed of recovery and time away from home. Result(s): Thermachoice EA was successfully performed in the OP setting on 89% (n ⫽ 24) of women. Four women in the first cohort required rescue analgesia compared to none in the second. During the procedure there was little difference between the groups visual analogue style pain scores—with the overall score being 3.6 (range ⫽ 0 –10). Postoperatively there was a lower mean pain score in the second cohort, with fewer women experiencing nausea and vomiting. Mean time away from home was 2.6 hours and mean time to make a full recovery was 3.3 days. Women required analgesia for 2.6 days, on average, and returned to their normal activities at this time. Conclusion(s): Thermachoice EA without local analgesia or IV sedation can be safely and successfully performed in the OP setting and if ibuprofen is taken preoperatively few women require “rescue analgesia.” (Fertil Steril威 2005;83:715–20. ©2005 by American Society for Reproductive Medicine.) Key Words: Endometrial ablation, outpatient, analgesia, anesthesia, menorrhagia
During the past 10 –15 years advances in daycase investigations and treatments have changed the way in which gynecological services are delivered in the United Kingdom. The Department of Health’s National Health Service plan aims to “further transfer inpatient care to daycase or ambulatory (outpatient) care thus reducing the length of hospital stay and shortening waiting times” (1).
There is now evidence to suggest that, if given a choice, women would prefer hysteroscopy to be performed in the OP setting as opposed to under general anesthesia (3). A randomized controlled trial comparing the cost of OP and DC hysteroscopy has shown a significant and considerable cost saving to the woman, her employer, and the NHS if the hysteroscopy is performed in the OP setting (4).
The role of outpatient (OP) diagnostic procedures is well established in gynecological practice. Hysteroscopy in the OP setting is now replacing daycase (DC) hysteroscopy under general anesthetia, as the investigation of choice for women with abnormal uterine bleeding.
Having established the role of diagnostic procedures, our unit has undertaken studies to investigate the potential benefits of therapeutic hysteroscopic procedures in the OP setting. Hysteroscopic polypectomy and hysteroscopic sterilization are currently being performed in this hospital without elective analgesia in the OP setting. Women are given the option of having “rescue” analgesia should they require it. These OP therapeutic procedures have been well tolerated and are acceptable to women (5).
When OP hysteroscopy, awake and without analgesia, was compared in a randomized controlled trial, to DC hysteroscopy patients had a reduced hospital stay, less time off work, and an earlier return to full mobility and fitness (2). Received April 16, 2004; revised and accepted August 26, 2004. Presented in poster format at the 12th Annual Congress of the European Society for Gynaecological Endoscopy, Luxembourg, November 26 – 29, 2003. Reprints requests: Dr. Fiona Marsh, Academic Department of Obstetrics and Gynaecology, University of Leeds, Level 9, Gledhow Wing, St. James’s University Hospital, Beckett Street, Leeds, LS9 7TF, United Kingdom (FAX: 0113-234-3450; E-mail: [email protected]).
0015-0282/05/$30.00 doi:10.1016/j.fertnstert.2004.08.030
Thermal balloon endometrial ablation (EA) using “Thermachoice” is another such therapeutic procedure. Thermachoice is a second-generation ablative technique that lends itself to OP treatment due to the thin (4.5 mm) diameter of the catheter. We performed Thermachoice EA, in the OP setting, without local anesthesia or IV sedation, on two cohorts of women
Fertility and Sterility姞 Vol. 83, No. 3, March 2005 Copyright ©2005 American Society for Reproductive Medicine, Published by Elsevier Inc.
715
with menorrhagia. This study aimed to determine whether Thermachoice EA is a safe and acceptable procedure when performed in the OP setting. MATERIALS AND METHODS Twenty-seven women with menorrhagia were recruited from the gynecology clinic of a large UK teaching hospital. All women had menorrhagia for at least the previous 6 months. For the purpose of this study menorrhagia was defined as excessive or prolonged menstrual flow, which is unacceptable to the patient. All women were counseled about the risks of Thermachoice EA including uterine perforation, infection, and pregnancy. All women in our study had completed their families and did not want a future pregnancy. They were given advice, if necessary, regarding contraception. Additional inclusion criteria were: a normal endometrial sample and scan or hysteroscopy within the preceding 6 months, negative cervical cytology within the preceding 3 years, and written informed consent. Exclusion criteria consisted of women with submucus fibroids, polyps, or premalignant lesions; a uterine cavity length of ⬎12 cm; pregnancy; pelvic inflammatory disease (PID) within the preceding 6 months; latex allergy; previous EA; myomectomy or classic cesarean section; and abnormal uterine bleeding of unknown cause. The primary objectives were to determine whether Thermachoice EA without local analgesia or intravenous sedation can be safely and successfully performed in the OP setting. The secondary objectives were to map visual analogue pain scores at different stages of the procedure; to determine the requirement for postoperative analgesia; to assess the speed of recovery and to assess time away from home. Thermachoice EA was performed in the “OP Hysteroscopy” room within the Daycase Unit. All facilities were available for resuscitation and patients had the use of a fully staffed recovery ward should they require it.
nate the treatment. Uterine contractions, which cause dysmenorrhoea and pelvic cramping, are believed to be caused by prostaglandins (6). The nonsteroidal anti-inflammatory drug ibuprofen has been shown to be the most effective anti-prostaglandins at treating dysmenorrhoea, with a low incidence of side effects (7). Ibuprofen has also been shown to reduce the resting pressure (P⬍.001), active pressure (P⬍.001), and frequency of cyclic activity of the nonpregnant uterus as well as menstrual pain (8). The second cohort of women underwent Thermachoice EA after taking elective ibuprofen. They were prescribed three ibuprofen 600-mg tablets preoperatively. They were asked to take one tablet at 10 PM the evening before treatment, one tablet 1 hour before treatment (as the peak serum concentration occurs after 60 –90 minutes), and one tablet 4 hours after the treatment. All women in the study had the option of receiving “rescue” analgesia in the form of nitrous oxide (inhaled), tramadol (50 –100 mg orally), or morphine sulfate (10 mg IM), should they require it. They were assured that, if at any stage they asked to stop the procedure, their request would be immediately respected and acted upon. Women were fully counseled about Thermachoice EA both verbally and with an information leaflet several weeks before undergoing the procedure. They were warned that they might experience “period type” cramp both during and after the procedure. One operator (FM) performed all the Thermachoice procedures. Data Collection Exactly the same prospective data were collected from both the first and second cohorts to allow for comparison. This included information on patient’s characteristics and operating details.
The first cohort of women underwent Thermachoice without elective analgesia (i.e., awake in the OP setting with no premedication, IV sedation, or local anesthetic).
To quantify the pain intensity experienced in the two cohorts of women, we opted to use a one-dimensional tool, the visual analogue scale (VAS). The VAS has been found to be a valid, reliable, and reproducible means of assessing pain (9). It is particularly useful for the setting of acute pain and is best used for the sequential evaluation of pain allowing for statistical analysis (10). Women were asked to place a vertical mark, using a slide rule, on a 100-mm horizontal VAS bounded by the descriptors “no pain” on the far left and “worst possible pain” on the far right. A VAS score was recorded at regular intervals (Fig. 1) throughout and after the procedure. One week after treatment women were asked to complete an “Assessment of Recovery” form, which included details of the length of time it took the woman to return to her normal activities, and how long she required postoperative analgesia.
Having mapped the pain scores and discussed the nature of the pain, we established that uterine cramping both during and after Thermachoice was most commonly responsible for women requiring “rescue” analgesia or requesting to termi-
Thermachoice Endometrial Ablation—The Procedure The Thermachoice I uterine balloon therapy system consists of a 16-cm long by 4.5-mm diameter catheter with a latex
Ethical Committee consent (Institutional Review Board approved) was obtained before recruitment into this study. There is currently no published data mapping pain scores during Thermachoice in the OP setting. Nor is there any information on the requirement of “rescue” analgesia or whether or not elective analgesia reduces discomfort during or after the procedure. We therefore planned to undertake this study in two phases.
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FIGURE 1 Mean visual analogue scale (VAS) pain scores during Thermachoice and postoperatively.
Marsh. Outpatient Thermachoice endometrial ablation. Fertil Steril 2005.
balloon at its distal end—this houses a heating element. The controller unit monitors, displays, and controls preset intraballoon pressure, temperature, and duration of treatment. For safety, the device automatically deactivates when the pressure falls below 45 mm Hg or rises above 200 mm Hg. After pelvic examination a Cuscoe’s speculum was passed vaginally to visualize the cervix. If necessary the cervical canal was dilated to 5 mm and the length of the uterine cavity was assessed with a “sound.” The Thermachoice balloon and catheter was inserted into the uterine cavity and filled with 5% dextrose, thus allowing the balloon to expand to fit the size and shape of the uterus. Intrauterine pressures of 160 –180 mm Hg were maintained at a temperature of 87°C for 8 minutes. When the treatment cycle was complete, all of the fluid was withdrawn from the balloon and the balloon and catheter were removed. RESULTS Patient’s characteristics and operative details are presented in Table 1. Our groups were matched for age, previous vaginal delivery, and number of women requiring cervical dilation. The cohort of women who underwent Thermachoice without elective analgesia is described as the first cohort, whereas those who took preoperative ibuprofen are described as the second cohort. Fertility and Sterility姞
Three women in this study had never had a vaginal delivery. One was nulliparous and the other two had undergone cesarean sections. Thermachoice EA was successfully performed in all three of these women in the OP setting. However, there were two women (one in each group) whose procedures were abandoned, because we were unable to dilate the cervical canal. Thermachoice was abandoned in another patient in the first group after 3 minutes, 36 seconds, at her request, as she experienced severe pelvic cramping pain. Figure 1 shows the VAS pain scores for both cohorts of women during and after Thermachoice was performed. During the procedure (i.e., up to and including the 8-minute mark in Fig. 1), there was little difference between the cohorts with regard to VAS pain scores—with the overall pain score being 3.6. One of the most uncomfortable parts of the procedure for both cohorts of women was the insertion of the Thermachoice catheter, with average pain score for all women of 4.2. The VAS pain scores for the first cohort of women gradually increased during the procedure from the attainment of a temperature of 87°C to the end of the treatment at 8 minutes. These women described the discomfort as cramping pelvic pain and several required “rescue” analgesia (Table 2). 717
TABLE 1 Patient characteristics and operative details.
Mean age (y) Mean duration of menorrhagia (y) Previous vaginal delivery Mean uterine cavity length (cm) Mean volume of dextrose required to inflate balloon to desired pressure (mL) No. of women requiring cervical dilation Successful 8-minute treatment
First cohort (n ⴝ 14)
Second cohort (n ⴝ 13)
40.9 7.0 86% (n ⫽ 12) 8.3 10.2
43.5 6.6 92% (n ⫽ 12) 8.5 10.3
50% (n ⫽ 7) 86% (n ⫽ 12)
69% (n ⫽ 9) 92% (n ⫽ 12)
The procedure was abandoned in two women (one from each group) due to failure to dilate the cervix. Another woman in the first group asked for the procedure to be stopped after 3 minutes 36 seconds due to pelvic cramping pain. P ⫽ not significant. Marsh. Outpatient Thermachoice endometrial ablation. Fertil Steril 2005.
The mean VAS pain scores for the second cohort of women peaked at the 4-minute mark (4.2) and then, in contrast to the first cohort, steadily decreased throughout the treatment and was at its lowest (1.4) after treatment. These women again complained of pelvic cramping pain; however, this was less severe than in the first cohort. Two hours after the Thermachoice procedure, the first cohort reported their highest average VAS pain score of 5.4, compared to 3.6 for the second cohort. There were four women in the first group who required “rescue” analgesia (Table 2). Three of these women had both nitrous oxide during the procedure and tramadol (100 mg orally) immediately after the procedure. One of these women went on to require morphine (10 mg) and Prochlorperazinetil (12.5 mg IM). Another woman declined intraoperative analgesia but requested tramadol (100 mg) postoperatively. There were no women in the second cohort who requested “rescue” analgesia. Similarly fewer women in the second cohort experienced nausea and vomiting after the treatment (Table 2). Thus, although ibuprofen provides no reduction in VAS pain scores initially, it does appear to reduce cramping pelvic pain during the latter half of treatment and after the procedure. Ibuprofen also appears to lessen the requirement for rescue analgesia and reduce nausea and vomiting rates.
Women who successfully underwent Thermachoice EA were asked whether they would recommend the treatment to a friend and whether they would opt to have the procedure performed in the OP setting in the future were they to require it again. Ninety-two percent of women replied and they all said they would recommend Thermachoice EA, performed in the OP setting, to a friend. Seventy-seven percent said that they would have the procedure performed in the OP setting again if they were to require it in the future. Table 3 contains data on the speed of women’s recovery and the amount of time they were away from their home to have the treatment performed. DISCUSSION Thermachoice EA without local analgesia or IV sedation can be safely and successfully performed in the OP setting. We successfully performed a full 8-minute treatment on 89% (n ⫽ 24/27) of women in the OP setting and there were no intra- or postoperative complications in this study. This is the first time that VAS pain scores have been mapped throughout Thermachoice EA in the OP setting. Our results show that during Thermachoice treatment the VAS scores are low, with an average score for both cohorts being
TABLE 2 Assessment of rescue analgesia requirement and nausea and vomiting rates.
Requirement for rescue analgesia Nausea Vomiting
First cohort (n ⴝ 14)
Second cohort (n ⴝ 13)
P value
33% (n ⫽ 4/12) 42% (n ⫽ 5/12) 25% (n ⫽ 3/12)
0% (n ⫽ 0) 8% (n ⫽ 1/12) 8% (n ⫽ 1/12)
.028 .059 NS
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TABLE 3 Assessment of recovery.
Mean Mean Mean Mean
time time time time
First group (n ⴝ 14)
95% confidence interval (range)
Second group (n ⴝ 13)
95% confidence interval (range)
3.9 2.6 2.8 2.6
(1.8–6) (1.3–3.9) (1.6–3) (2.2–3)
2.8 2.7 2.7 2.6
(1.6–4) (1.3–4.1) (1.3–4.1) (2.1–3.1)
to full recovery (days) pain relief required (days) to return to normal activities (days) away from home (hours)
P ⫽ not significant. Marsh. Outpatient Thermachoice endometrial ablation. Fertil Steril 2005.
3.6. One of the most uncomfortable parts of the treatment (for all women regardless of cohort) was the insertion of the Thermachoice catheter with an average VAS score of 4.2. Unsurprisingly ibuprofen had no advantageous effect on either this score or the discomfort felt when inserting the uterine sound. This is probably because the pain experienced at this stage is due to dilatation of the cervical canal. However, these pain scores compare favorably to those experienced by women when inserting an intrauterine coil device (IUCD). A randomized controlled trial by D’Souza et al. (11) compared the acceptability of frameless intrauterine coil device (IUCD) to a plastic T-framed IUCD. The mean VAS pain scores (0 –10) at insertion of these devices were 5.7 and 4.8, respectively. The introduction of ibuprofen significantly reduced the number of women who required “rescue” analgesia both during and after the treatment. The only woman who asked to stop the treatment despite “rescue” analgesia was in the first cohort. All women who had preoperative ibuprofen completed the treatment and experienced less nausea and vomiting than the group who had no elective analgesia. After the Thermachoice procedure there was also a lower mean pain score in the ibuprofen group at both 30 minutes and 2 hours after treatment. In view of these advantages we have continued to prescribe preoperative ibuprofen to women undergoing Thermachoice EA in the OP setting. The safety and efficacy of Thermachoice is well established; however, the vast majority have been performed under general anesthesia with the inherent risks and side effects involved. There have been a small number of studies looking at Thermachoice under local anesthetia and it appears to be well tolerated by patients. However, the role of local anesthesia in the reduction of pain for OP gynecological procedures has not been confirmed. Fernandez et al. (12) performed Thermachoice on 18 patients in the OP setting under local anesthesia. They gave ketoprofen or paracetomol preoperatively followed by a paracervical block with 20 mL of 1% lignocaine (with epinephrine1:200,000). An additional 20 mL of 1% lignocaine was injected into the endoFertility and Sterility姞
cervical canal, isthmus and uterocervical ligaments. The mean VAS pain scales (0 –10) during the procedure in the Fernandez et al. study were 3.8, which is similar to the mean VAS pain score in this study of 3.6. These findings once again question the beneficial role of local anesthesia in OP gynecological procedures. Several studies have been reported looking at the role of local anesthesia in OP hysteroscopy. Paracervical and intracervical lignocaine have been shown to be as painful as the hysteroscopy itself and do not reduce the discomfort felt during the procedure (13–15). Paracervical block has the added risk of intravasation and severe side effects have been reported (16). Likewise, studies comparing lignocaine gel and lignocaine spray to placebo have shown no significant difference when assessing pain (17, 18). Thus there is evidence to suggest that local anesthesia does not appear to improve the success rate or reduce discomfort when performing OP gynecological procedures and it can be painful and potentially dangerous. In several other studies of Thermachoice in the OP setting women were given IV sedation such as midazolam, fentanyl, and propofol (19). There are several disadvantages to IV sedation including the risk of respiratory depression and increased need for resuscitative measures. In a study by Duggan and Dodd (19) using IV sedation they concluded that the additional observations required to ensure safe administration of intraoperative sedation probably preclude balloon ablation as a suitable office procedure. Thus there is no evidence to support the use of either local anesthesia or IV sedation in the OP setting. This study shows that women from both cohorts were, on average, away from their homes for only 2.5 hours to have Thermachoice treatment. This study also found that women were returning to their normal activities within 2–3 days. Most people would agree that less time forgone from normal activities has an important value to the woman, her family, her employer, and society as a whole. 719
An increasing number of diagnostic and therapeutic procedures are being performed in the OP setting and offer many advantages to both the woman and the NHS. Ambulatory therapy not only expedites treatment, thus reducing waiting lists, but also provides cost savings to the women, her employer, and the NHS (4). Furthermore, the avoidance of general anesthesia in women with coexistent medical morbidity means that OP treatment should be safer in this higher risk group. The Department of Health’s NHS plan aims to promote “treatments which are shown to be clinically and costeffective” and “shape these treatments around the convenience and concerns of patients” (1). Thermachoice EA in the OP setting offers several benefits over performing Thermachoice in the DC setting, not least the avoidance of general anesthetia and its associated risks. It also obviates the need for an anesthetist and operating theater staff and resources. Therefore, Thermachoice EA in the OP setting not only provides potential clinical advantages to the woman but also cost savings to both her and the health service. To verify this, a randomized controlled trial comparing OP and daycase, Thermachoice needs to be undertaken to determine differences in patient acceptability, pain scores, complication rates, recovery time, time away from home, and cost to the woman, her employer, and the health service. In conclusion, Thermachoice EA without local analgesia or IV sedation can be safely and successfully performed in the OP setting. If ibuprofen is taken preoperatively it appears that very few women require any form of rescue analgesia. Thermachoice EA in the OP setting offers potential clinical advantages and cost savings to the woman and the health service. REFERENCES 1. NHS. The NHS Plan. Department of Health. www.doh.co.uk. 2. Kremer C, Duffy S, Moroney M. Patient satisfaction with outpatient hysteroscopy versus day case hysteroscopy: randomised controlled trial. Brit Med J 2000;320:282–3.
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3. Marsh FA, Taylor L, Kremer C, Duffy S. Delivering an effective outpatient service in gynaecology. An assessment of patients’ preference. Gynaecol Endosc 2002;1:337– 43. 4. Marsh FA, Kremer SD, Duffy S. Delivering an effective outpatient service in gynaecology. A randomised controlled trial analysing the cost of outpatient versus daycase hysteroscopy. BJOG 2004; 111:243– 8. 5. Rogerson L, Hudson H, Duffy S. UK Experience using the ESSURE micro-insert for hysteroscopic sterilisation. Rev Gynaecolo Pract 2003; 3:1– 4. 6. Furniss LD. Nonsteroidal anti-inflammatory agents in the treatment of primary dysmenorrhoea. Clin Pharm 1982;1:327–33. 7. Zhang WY, Li Wan Po A. Efficacy of minor analgesics in primary dysmenorrhoea: a systematic review. BJOG 1998;105:780 –9. 8. Pulkkinen MO, Csapo AI. The effect of ibuprofen on the intrauterine pressure and menstrual pain of dysmenorrheic patients. Prostaglandins 1978;15:1055– 62. 9. Kendall H, Spence J, Murphy M. Review of pain measurement tools. Ann Emerg Med 1996;27:427–32. 10. Gallagher E, Lieban M, Bijur, P. Prospective validation of clinically important changes in pain severity measured on a visual analogue scale. Ann Emerg Med 2001;38:633– 8. 11. D’Souza R, Masters T, Bounds W, Guillebaud J. Randomised controlled trial assessing the acceptability of Gynefix versus Gyne-T380S for emergency contraception. J Fam Plan Reprod Health Care 2003; 29:23–9. 12. Fernandez H, Capella S, Audibert F. Uterine thermal balloon therapy under local anaesthesia for the treatment of menorrhagia. Hum Reprod 1997;12:2511– 4. 13. Lau WC, Lo WK Tam WH, Yeun PM. Paracervical anaesthesia in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. BJOG 1999;106:356 –9. 14. Vercellini P, Colombo A, Mauro F, Oldani S, Bramante T, Crosignani PG. Paracervical anaesthesia for outpatient hysteroscopy. Fertil Steril 1994;5:1083–5. 15. Broadbent JA, Hill NC, Molnar BG, Rolfe KJ, Magos AL. Randomised placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. BJOG 1992;99:777– 80. 16. Mercado AO, Naz JF, Ataya KM. Postabortal paracervical block abscess as a complication of paracervical block anaesthesia. A case report. J Reprod Med 1989;34:247–9. 17. Clark S, Vonau B, Macdonald R. Topical anaesthesia in outpatient hysteroscopy. Gynae Endosc 1996;5:141– 4. 18. Davies A, Richardson RE, O’Connor H, Baskett TF, Nagele F, Magos AL. Lignocaine aerosol spray in outpatient hysteroscopy: a randomised double-blind placebo-controlled trial. Fertil Steril 1997;97:1019 –23. 19. Duggan PM, Dodd J. Endometrial balloon ablation under local analgesia and intravenous sedation. Aust NZ J Obstet Gynaecol 1999;39: 123– 6.
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