- Email: [email protected]
Pain Relief and Outpatient Hysteroscopy: A Literature Review
August 2004, Vol. 11, No. 3
The Journal of the American Association of Gynecologic Laparoscopists
Review Article
Pain Relief and Outpatient Hysteroscopy: A Literature Review Emma Readman, M.B., B.S., FRANZCOG, and Peter J. Maher, M.B., B.S., FRANZCOG Abstract
(J Am Assoc Gynecol Laparosc 2004, 11(3):315–319)
Our early experience in setting up an ambulatory hysteroscopy service provoked a review of the literature, due to an unacceptably high failure rate. A literature review has been undertaken to establish the accepted success rates and reasons for failure, and to assess evidence for various analgesic protocols through randomized controlled trials. The data suggest the procedure is acceptable to most patients, with a completion success rate over 90%, and the use of analgesia may enhance the success rate. Analgesic protocols studied were nonsteroidal anti-inflammatory drugs, intracervical block, paracervical block, transcervical block, and topical analgesia. Failures are due predominantly to pain, stenosis, and poor view.
Abnormal uterine bleeding accounts for one third of all gynecologic patient visits1 and requires investigation. An assessment of the uterine cavity is undertaken, with or without endometrial sampling. The uterine cavity can be assessed by: transvaginal ultrasound, saline infusion sonography (SIS), or hysteroscopy. Endometrial sampling can be performed at the time of hysteroscopy using any one of a number of devices, which work by aspiration and/or curettage. Inpatient hysteroscopy is the “gold standard” in assessing the uterine cavity, having been shown to have a sensitivity of 98% compared with 65% for dilatation and curettage (D&C) alone.2,3 However, ambulatory procedures are finding increasing favor given the obvious advantages to the patient of having a procedure done as an outpatient and its cost effectiveness. The accuracy of transvaginal ultrasound makes it hard to justify as a stand-alone procedure, although it is very useful in assessing the adnexa and identifying extracavity myomas. One group of researchers found that transvaginal ultrasound is only 54% sensitive and 90% specific for intracavity lesions, and other researchers determined that in order to plan management adequately both hysteroscopy and ultrasound are needed.4,5 More recently, increased interest has been shown in SIS and outpatient hysteroscopy. Saline infusion sonography has been gaining increasing acceptance as an investigational tool, reporting results similar to outpatient hysteroscopy.6 Outpatient hysteroscopy has the added advantages of allowing direct visualization the uterine cavity, thus more easily distinguishing between polyps and myomas,7 and allowing the removal of small polyps hysteroscopically. The main problems associated with outpatient hysteroscopy are pain management and cervical stenosis.8
At Mercy Hospital for Women, outpatient hysteroscopy service commenced in 2000. The first author found there was an unacceptably high failure rate in her first 27 procedures. She performed a literature search to find the optimal regimen. Materials and Methods A literature search was undertaken using PUBMED (1980 through April 2002), with “ambulatory hysteroscopy” as the keywords. This was refined further by combining the results of that search with “pain,” “local anesthetic,” and “success” as keywords. Thirty-one articles were found. The bibliographies of all these articles were checked for articles not appearing in the search, and a total of 40 articles/ communications were finally included in this review. Twenty-nine were suitable for analysis, and 11 were letters/ communications/background information. The articles chosen for inclusion were articles whose original data included success rates, failure rates, pain measurements, acceptability, the analgesia regimen used, and the means of performing the hysteroscopy. There was no attempt to directly compare the nonrandomized, controlled trials, but the data in those articles were collated to show rates of success/ failure, acceptability/pain levels, and reasons for failure/side effects. The studies reviewed are those randomized, controlled studies, comparing modalities of performing ambulatory hysteroscopy. Results Populations Studied The total number of women undergoing outpatient hysteroscopy in the articles reviewed was 10 232. Of the
From the Endosurgery Unit, Mercy Hospital for Women, Victoria, Australia (both authors). Corresponding author Emma Readman, M.B., B.S., Endosurgery Unit, Mercy Hospital for Women, Clarendon Street, East Melbourne, 3002 Victoria, Australia. Submitted July 21, 2003. Accepted for publication March 17, 2004. Reprinted from the JOURNAL OF THE AMERICAN ASSOCIATION OF GYNECOLOGIC LAPAROSCOPISTS, August 2004, Vol. 11 No. 3 © 2004 The American Association of Gynecologic Laparoscopists. All rights reserved. This work may not be reproduced in any form or by any means without written permission from the AAGL. This includes but is not limited to, the posting of electronic files on the Internet, transferring electronic files to other persons, distributing printed output, and photocopying. To order multiple reprints of an individual article or request authorization to make photocopies, please contact the AAGL.
315
Pain Relief and Outpatient Hysteroscopy Readman and Maher
Patient Acceptability Only seven authors addressed the issue of patient acceptability specifically.9,11,15,17,20–22 It is difficult to compare the results among studies because each group used different measurement parameters and analgesia protocols. In general, acceptability/tolerability was assessed by postprocedure questionnaires (Table 1). The main conclusions from the results are that ambulatory hysteroscopy seems to be acceptable to 83%–99% of the population; pain is the limiting factor in acceptability, and no analgesic gives better acceptability (not statistically significant).
populations analyzed for parity, 1220 of 3373 women (36.2%) were nulliparous; and of the populations stratified by menopausal status, 2109 of 6833 women (30.9%) were postmenopausal. There was no difference in successful hysteroscopies in any particular population group. Success Rate of Outpatient Hysteroscopy Success is seen as the ability to complete the hysteroscopy, obtaining an adequate view. Success rates in the published series ranged from 69% to 100% with most series showing 90%–100% success rates. There was no trend toward an increased success rate with any particular analgesia protocol, nor with any particular group of women, although some controlled trials showed better success rates compared with controls (see below). Six of 29 articles, studying a total of 1810 women, had 100% success rates for their series9–14 and one of 29, studying 69 patients, did not list its success rate.15 It does not seem reasonable to promote a procedure that has a greater than 10% failure rate.
Side Effects The main side effects of hysteroscopy are vagal reactions, shoulder tip pain, cramping, tremor, nausea, and bleeding. Up to 70% (168/236) of patients experience one or more side effect.23 The incidence of vagal reactions depends on how scrupulously the patient is monitored. If blood pressure and pulse changes are measured, as well as symptoms recorded, the results are much higher than if only clinically significant events are reported. If clinically significant events only were reported, the incidence varied from 0.5%–9%.12,18,20,21,24–28 Most patients did not need treatment. If all these parameters were carefully monitored, the incidence varied from 5%–32.5%.12,14,29–31 Shoulder tip pain occurred in 13%–25%. A small number (0.5%–2.5%) of patients had clinically significant events.21,23,25,26,30,32 The other symptoms were not routinely recorded. When specifically measured, 21% had cramping, 18% had tremor, 3% had nausea, and 38.8% bleeding.23,29
Reasons for Failure of Outpatient Hysteroscopy Failure is the inability to gain access and/or an adequate view during hysteroscopy. The most common reasons for failure are cervical stenosis, pain, and poor view. Other reasons are inability to visualize the cervix, vagal reaction, anxiety, extreme retroversion, and nonspecific technical problems. Some articles did not specify the reasons for failure.15–18 In those articles where reasons for failure were specified (in those who had a success rate between 90%–100%), 29.4% (72/245) of procedures failed because of pain, 28.2% (69/245) because of stenosis, and 20.8% (51/245) because of poor view, accounting for 78.4% of all failed procedures. In a cohort analysis of semirigid hysteroscopy, stenosis was the bigger problem (67.9% of failures), which the authors attributed to limiting the dilatation of the cervix to a No. 3 dilator in order to reduce patient discomfort.19 There was no trend toward increased failure in any one demographic group.
Reducing Pain: How Can the Success be Improved? The main factor affecting outcome in ambulatory hysteroscopy is pain. If we consider each component of the outpatient hysteroscopy to assess its contribution to overall pain, the majority of articles concluded that the grasping of
Table 1. Patient Acceptability of Outpatient Hysteroscopy
Analgesia None9 None21 None20 Intracervical block15 Paracervical block Uterosacral block11 Naproxen Sodium/transcervical block22 Topical gel/intracervical block Placebo/intracervical block17
No. of Patients
Preferring GA Next Operation No. (%) 89 (48) 189 (16.5) NS 8 (11.6) 1 (1.7) 2 (3.3) NS NS
185 1144 554 69 60 60 99 44 44
GA = general anesthesia; NS = not specified. aScore on a mean acceptability score, with 10 as maximum acceptability.
316
Acceptable
Problem
8.3a NS 84% NS NS
NS Intolerable pain Pain Pain NS
9.3–9.9a 84%
NS Pain
August 2004, Vol. 11, No. 3
The Journal of the American Association of Gynecologic Laparoscopists
a 22-gauge spinal needle at three, five, seven, and nine o’clock paracervically. The trial showed that there was a statistically significant improvement in pain control at insertion of the scope but at no other time during the procedure and that the injection was as painful as the procedure.30
the cervix by a tenaculum was a small but significant cause of pain,10,33 the instillation of local anesthetic can be “as painful as the rest of the procedure,”29,32 cervical dilatation was a significant cause of pain,18,28 insertion of the hysteroscope and the remainder of the procedure were equally painful, and the larger the diameter of the telescope used the more pain was caused.12, 29 There was no agreement as to whether normal saline or CO2 is more painful. In two studies, CO2 was less painful,15,24 and in one study, saline was less painful.27 The biopsy was as painful, or even more painful, than the procedure.9,29–31,34 The problem with comparing studies performed to date was a wide variation in the use of the speculum, tenaculum, dilatation of the cervix, and telescope size, from a 2.7-mm flexible scope to a 5-mm rigid telescope. Different distention media were used (CO2, normal saline, glycine) together with variable levels of intrauterine pressure. Not all studies performed or recorded the taking of an endometrial biopsy. When considering analgesic protocols, different amounts of analgesia were given, with variable waiting times before commencing the procedure, and different sized needles were used. All of these factors impacted on the pain experienced and its control. Pain assessments were also different, with different groups measuring pain at different points in the procedure.
Intracervical Block One-hundred women were randomized to receive either 10 mL of 1% lignocaine with adrenaline or 10 mL of saline injected using a 22-gauge needle into the cervix at one, five, seven, and 11 o’clock. No statistically significant difference in pain between the two groups was found. Sixty-five percent of the women rated the injection as painful or more painful than the rest of the procedure.32 Transcervical Block One-hundred women were randomized to receive either 5 mL of 2% lignocaine or normal saline via the channel of the hysteroscope at its introduction, followed by a wait of 2 minutes before commencing. The study found a trend to reduction of pain in the study group, reaching statistical significance at reducing the pain of endometrial biopsy in those who had not had a previous vaginal delivery or D&C or who were postmenopausal. All patients took naproxen sodium orally 1 hour before the procedure, and the cervix was sprayed with lignocaine. All pain scores were low, and it was thought that there might not have been a sufficient delay before commencing the procedure.22 In another study, 80 postmenopausal women were randomized to receive either 2 mL of 2% mepivacaine or saline by catheter 5 minutes preprocedure. The researchers found a statistically significant reduction in pain in the study group and fewer vagal reactions.12 Other researchers randomized 45 women to receive either 5 mL of 2% mepivacaine or saline 3 minutes preprocedure. Pain rated by an observer was statistically lower in the study group, and a trend toward decreased pain was reported by the subjects.13 In another study, 90 women were randomized to receive either 5 mL of 2% lignocaine or saline 5 minutes preprocedure. There was no difference in pain scores between the two groups.31
Anesthesia Paracervical Block One study randomized 181 premenopausal women to receive either no anesthesia or 10 mL of mepivacaine hydrochloride with a 22-gauge spinal needle at three, five, seven, and nine o’clock paracervically. There was no significant difference in pain scores between the groups. Potential confounders were that the two groups were not blinded to the administration of anesthesia, and there was no placebo injection control.34 Another study randomized 120 women to either 16–20 mL of 1% lignocaine as a paracervical block or 1 mL of 2% lignocaine into each uterosacral ligament. Both groups also received a small amount (0.5 mL) into the anterior lip before placement of the tenaculum. There was no difference between the two groups in pain scores.11 Other researchers randomized 362 postmenopausal women into one of three groups. They used a hysteroscope with a 5-mm sheath without anesthesia; a 5-mm sheath with 20 mL of 1% mepivacaine injected with a 21-gauge needle at three, five, seven, and nine o’clock paracervically; and a 3.5-mm hysteroscope without anesthesia. A statistically significant improvement in pain scores was obtained in the paracervical group compared with the 5-mm sheath, no-anesthesia group. The use of a 3.5-mm hysteroscope was associated with the lowest pain score (6.3/10 vs 5.3/10 vs 4.5/10). However, there was a decreased success rate with a smaller scope because of poor view. The arms were not blinded, and there was no placebo injection control.29 In another study, 100 women were randomized to 10 mL of 2% lignocaine or 10 mL of saline injected using
Topical Analgesia Eighty-eight women were randomized to receive either 10 mL of 2% lignocaine gel or placebo. A trend toward decreased pain was found if injection of local anesthetic was needed; otherwise, no difference in pain was found.17 In another study, 500 women were randomized to receive either 4 mL of 2% lignocaine gel or placebo. No difference in the pain between the two groups was found.31 In three other studies with a combined total of 541 women, a statistically significant benefit was found of applying lignocaine spray (either 30 mg, 50 mg, or 100 mg) to the cervix and cervical canal.28,33,35 One of the studies showed benefit at insertion and during the hysteroscopy, with decreased vasovagal reactions and shoulder tip pain;33 one in overall pain and decreased need for local anaesthetic;35 and one in pain from the tenaculum.28
317
Pain Relief and Outpatient Hysteroscopy Readman and Maher
In a study of 180 women, group A received a cream containing 25 mg of lignocaine and 25 mg of prilocaine, group B received 40 mg of lignocaine spray, and group C received no anesthetic. Both groups A and B showed a statistically significant decrease in pain at insertion and during the procedure and a decreased incidence of vasovagal reactions. In group A the hysteroscopy took less time, and there was a decreased incidence of tenaculum pain and shoulder tip pain. Compared with the spray, the cream was more effective in reducing pain during the procedure, but the cream made vision more difficult, needing to be wiped off the cervix and defogging spray applied to the telescope.14
6. Soares SR, Batista BR, Marcos M, et al: Diagnostic accuracy of sonohysterography, transvaginal sonography, and hysterosalpingography in patients with uterine cavity diseases. Fertil Steril 2000, 73:406–11.
Nonsteroidal Anti-Inflammatory Drugs Ninety-five women were randomized to receive 500 mg of naproxen or placebo 1 hour before the procedure. If there was discomfort during the procedure, intracervical lignocaine was used. The study showed a statistically significant reduction in pain at 30 and 60 minutes postprocedure with pharmacologic therapy.36
10. Bettocchi S, Selvaggi L: A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc 1997, 4:255–8.
7. Rogerson L, Bates J: A comparison of outpatient hysteroscopy with saline infusion hysterosonography. Br J Obstet Gynaecol 2002, 109:800–4. 8. Habiba MA: Diagnostic accuracy of outpatient hysteroscopy. Am J Obstet Gynecol 1997, 176:1399–1400. 9. Lau WC, Ho RYF, et al: Patient’s acceptance of outpatient hysteroscopy. Gynecol Obstet Invest 1999, 47:191–3.
11. Finikiotis G, Tsocanos S: Outpatient hysteroscopy: A comparison of 2 methods of local analgesia. Aust NZ J Obstet Gynaecol 1992, 32:373–4. 12. Cicinelli E, Didonna T, Ambrosi G, et al: Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: A randomised placebo-controlled doubleblind study. Br J Obstet Gynaecol 1997, 104:316–9.
Conclusion For the diagnosis and, in some cases, treatment of abnormal uterine bleeding ambulatory hysteroscopy is a safe, reliable alternative that is acceptable to patients when compared with hysteroscopy under general anesthetic. From available studies, it seems reasonable to use nonsteroidal anti-inflammatory drugs 1 hour preprocedure if not contraindicated, and topical analgesia (e.g., lignocaine spray) before the insertion of the hysteroscope. It would be logical to reserve the use of the tenaculum for difficult insertions, to use a paracervical block if dilatation is required, and try smaller hysteroscopes if larger ones fail. Whether saline or CO2 should be used routinely is not clear, and an endometrial biopsy should be reserved for specific indications. The use of other blocks is not proven, but may be useful in selected cases.
13. Zupi E, Luciano A, Valli E, et al: The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy. Fertil Steril 1995, 63:414–6. 14. Zullo F, Pellicano M, Stigliani C, et al: Topical anesthesia for office hysteroscopy: A prospective randomized study comparing two modalities. J Reprod Med 1999, 44:865–9. 15. Cutner A, Erian J: Who should have an outpatient hysteroscopy? Gynaecol Endoscopy 1996, 5:231–4. 16. Lorino C, Prough S, Aksel S, et al: Pain relief in hysterosalpingography. A comparison of analgesics. J Reprod Med 1990, 35:533–536. 17. Clark S, Vonau B, Macdonald R: Topical anaesthesia in outpatient hysteroscopy. Gynaecol Endoscopy 1996, 5:141–44. 18. Wong AYK, Wong KS, Tang LCH: Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: A randomized, double-blind, placebo-controlled trial. Fertil Steril 2000, 73:1234–7.
References 1. Coulter A, McPherson K, Vessey M: Do British women undergo too many or too few hysterectomies? Soc Sci Med 1988, 27:987–94.
19. Salha O, Okeahialam M, Jones S, et al: Outpatient microhysteroscopy: Why does it fail? Gynaecol Endoscopy 2001, 10:167–71.
2. Gimpleson RJ, Rappold HO: A comparative study between panoramic hysteroscopy with directed biopsies and dilatation and curettage. Am J Obstet Gynecol 1988, 158:489–92.
20. Kremer C, Barik S, Duffy S: Flexible outpatient hysteroscopy without anaesthesia: A safe, successful and well tolerated procedure. Br J Obstet Gynaecol 1998, 105:672–6.
3. Loffer FD: Hysteroscopy with selective endometrial sampling compared with D&C for abnormal uterine bleeding: The value of a negative hysteroscopic view. Obstet Gynecol 1989, 73:16–20.
21. De Iaco P, Marabini A, Stefanetti M, et al: Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc 2000, 7:71–5.
4. Badawy A, Ash F, Nagele H, et al: Ultrasonography, hysteroscopy or both? J Obstet Gynecol 1996, 16:551–5.
22. Costello MF, Horrowitz SD, Williamson M: A prospective randomised double-blind placebo controlled study of local anaesthetic injected through the hysteroscope for outpatient hysteroscopy and endometrial biopsy. Gynaecol Endoscopy 1998, 7:121–6.
5. Towbin NA, Israel MG, March CM: Office hysteroscopy versus transvaginal ultrasonography in the evaluation of patients with excessive uterine bleeding. Am J Obstet Gynecol 1996, 174:1678–82.
318
August 2004, Vol. 11, No. 3
The Journal of the American Association of Gynecologic Laparoscopists
23. Finikiotis G: Side-effects and complications of outpatient hysteroscopy. Aust NZ J Obstet Gynaecol 1993, 33:61–2.
31. Lau WC, Tam WH, Lo W, et al: A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy. Br J Obstet Gynaecol 2000, 107:610–3.
24. Bellingham FR: Outpatient hysteroscopy: Problems. Aust NZ J Obstet Gynaecol 1997, 37:202–5.
32. Broadbent JAM, Hill NCW, Molnar B, et al: Randomised placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. Br J Obstet Gynaecol 1992, 99:777–80.
25. De Jong P, Doel F, Falconer A: Outpatient diagnostic hysteroscopy. Br J Obstet Gynaecol 1990, 97:299–303. 26. Hill NCW, Broadbent JAM, Magos AL: Local anaesthesia and cervical dilatation for outpatient diagnostic hysteroscopy. J Obstet Gynaecol 1992, 12:33–7.
33. Davies A, Richardson RE, O’Connor H, et al: Lignocaine aerosol spray in outpatient hysteroscopy: A randomised double-blind placebo-controlled trial. Fertil Steril 1997, 67:1019–23.
27. Nagele F, O’Connor H, Davies A, et al: 2500 outpatient diagnostic hysteroscopies. Obstet Gynecol 1996, 88:87–92. 28. Soriano D, Ajay S, Chuong T, et al: Lidocaine spray and outpatient hysteroscopy: Randomized placebo-controlled trial. Obstet Gynecol 2000, 96:661–4.
34. Vercellini P, Colombo A, Mauro F, et al: Paracervical anesthesia for outpatient hysteroscopy. Fertil Steril 1994, 62:1083–5.
29. Giorda G, Scarabelli C, Franceschi S, et al: Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: A randomised trial. Acta Obstet Gynecol Scand 2000, 79:593–7.
35. Wieser F, Kurz C, Wenzl R, et al: Atraumatic cervical passage at outpatient hysteroscopy. Fertil Steril 1998, 69:549–51. 36. Nagele F, Lockwood G, Magos AL: Randomised placebo controlled trial of mefanamic acid for premedication at outpatient hysteroscopy: A pilot study. Br J Obstet Gynaecol 1997, 104:842–4.
30. Lau WC, Lo WK, Tam W, et al: Paracervical anaesthesia in outpatient hysteroscopy: A randomised double blind placebocontrolled trial. Br J Obstet Gynaecol 1999, 106:356–9.
319
The Journal of the American Association of Gynecologic Laparoscopists
Review Article
Pain Relief and Outpatient Hysteroscopy: A Literature Review Emma Readman, M.B., B.S., FRANZCOG, and Peter J. Maher, M.B., B.S., FRANZCOG Abstract
(J Am Assoc Gynecol Laparosc 2004, 11(3):315–319)
Our early experience in setting up an ambulatory hysteroscopy service provoked a review of the literature, due to an unacceptably high failure rate. A literature review has been undertaken to establish the accepted success rates and reasons for failure, and to assess evidence for various analgesic protocols through randomized controlled trials. The data suggest the procedure is acceptable to most patients, with a completion success rate over 90%, and the use of analgesia may enhance the success rate. Analgesic protocols studied were nonsteroidal anti-inflammatory drugs, intracervical block, paracervical block, transcervical block, and topical analgesia. Failures are due predominantly to pain, stenosis, and poor view.
Abnormal uterine bleeding accounts for one third of all gynecologic patient visits1 and requires investigation. An assessment of the uterine cavity is undertaken, with or without endometrial sampling. The uterine cavity can be assessed by: transvaginal ultrasound, saline infusion sonography (SIS), or hysteroscopy. Endometrial sampling can be performed at the time of hysteroscopy using any one of a number of devices, which work by aspiration and/or curettage. Inpatient hysteroscopy is the “gold standard” in assessing the uterine cavity, having been shown to have a sensitivity of 98% compared with 65% for dilatation and curettage (D&C) alone.2,3 However, ambulatory procedures are finding increasing favor given the obvious advantages to the patient of having a procedure done as an outpatient and its cost effectiveness. The accuracy of transvaginal ultrasound makes it hard to justify as a stand-alone procedure, although it is very useful in assessing the adnexa and identifying extracavity myomas. One group of researchers found that transvaginal ultrasound is only 54% sensitive and 90% specific for intracavity lesions, and other researchers determined that in order to plan management adequately both hysteroscopy and ultrasound are needed.4,5 More recently, increased interest has been shown in SIS and outpatient hysteroscopy. Saline infusion sonography has been gaining increasing acceptance as an investigational tool, reporting results similar to outpatient hysteroscopy.6 Outpatient hysteroscopy has the added advantages of allowing direct visualization the uterine cavity, thus more easily distinguishing between polyps and myomas,7 and allowing the removal of small polyps hysteroscopically. The main problems associated with outpatient hysteroscopy are pain management and cervical stenosis.8
At Mercy Hospital for Women, outpatient hysteroscopy service commenced in 2000. The first author found there was an unacceptably high failure rate in her first 27 procedures. She performed a literature search to find the optimal regimen. Materials and Methods A literature search was undertaken using PUBMED (1980 through April 2002), with “ambulatory hysteroscopy” as the keywords. This was refined further by combining the results of that search with “pain,” “local anesthetic,” and “success” as keywords. Thirty-one articles were found. The bibliographies of all these articles were checked for articles not appearing in the search, and a total of 40 articles/ communications were finally included in this review. Twenty-nine were suitable for analysis, and 11 were letters/ communications/background information. The articles chosen for inclusion were articles whose original data included success rates, failure rates, pain measurements, acceptability, the analgesia regimen used, and the means of performing the hysteroscopy. There was no attempt to directly compare the nonrandomized, controlled trials, but the data in those articles were collated to show rates of success/ failure, acceptability/pain levels, and reasons for failure/side effects. The studies reviewed are those randomized, controlled studies, comparing modalities of performing ambulatory hysteroscopy. Results Populations Studied The total number of women undergoing outpatient hysteroscopy in the articles reviewed was 10 232. Of the
From the Endosurgery Unit, Mercy Hospital for Women, Victoria, Australia (both authors). Corresponding author Emma Readman, M.B., B.S., Endosurgery Unit, Mercy Hospital for Women, Clarendon Street, East Melbourne, 3002 Victoria, Australia. Submitted July 21, 2003. Accepted for publication March 17, 2004. Reprinted from the JOURNAL OF THE AMERICAN ASSOCIATION OF GYNECOLOGIC LAPAROSCOPISTS, August 2004, Vol. 11 No. 3 © 2004 The American Association of Gynecologic Laparoscopists. All rights reserved. This work may not be reproduced in any form or by any means without written permission from the AAGL. This includes but is not limited to, the posting of electronic files on the Internet, transferring electronic files to other persons, distributing printed output, and photocopying. To order multiple reprints of an individual article or request authorization to make photocopies, please contact the AAGL.
315
Pain Relief and Outpatient Hysteroscopy Readman and Maher
Patient Acceptability Only seven authors addressed the issue of patient acceptability specifically.9,11,15,17,20–22 It is difficult to compare the results among studies because each group used different measurement parameters and analgesia protocols. In general, acceptability/tolerability was assessed by postprocedure questionnaires (Table 1). The main conclusions from the results are that ambulatory hysteroscopy seems to be acceptable to 83%–99% of the population; pain is the limiting factor in acceptability, and no analgesic gives better acceptability (not statistically significant).
populations analyzed for parity, 1220 of 3373 women (36.2%) were nulliparous; and of the populations stratified by menopausal status, 2109 of 6833 women (30.9%) were postmenopausal. There was no difference in successful hysteroscopies in any particular population group. Success Rate of Outpatient Hysteroscopy Success is seen as the ability to complete the hysteroscopy, obtaining an adequate view. Success rates in the published series ranged from 69% to 100% with most series showing 90%–100% success rates. There was no trend toward an increased success rate with any particular analgesia protocol, nor with any particular group of women, although some controlled trials showed better success rates compared with controls (see below). Six of 29 articles, studying a total of 1810 women, had 100% success rates for their series9–14 and one of 29, studying 69 patients, did not list its success rate.15 It does not seem reasonable to promote a procedure that has a greater than 10% failure rate.
Side Effects The main side effects of hysteroscopy are vagal reactions, shoulder tip pain, cramping, tremor, nausea, and bleeding. Up to 70% (168/236) of patients experience one or more side effect.23 The incidence of vagal reactions depends on how scrupulously the patient is monitored. If blood pressure and pulse changes are measured, as well as symptoms recorded, the results are much higher than if only clinically significant events are reported. If clinically significant events only were reported, the incidence varied from 0.5%–9%.12,18,20,21,24–28 Most patients did not need treatment. If all these parameters were carefully monitored, the incidence varied from 5%–32.5%.12,14,29–31 Shoulder tip pain occurred in 13%–25%. A small number (0.5%–2.5%) of patients had clinically significant events.21,23,25,26,30,32 The other symptoms were not routinely recorded. When specifically measured, 21% had cramping, 18% had tremor, 3% had nausea, and 38.8% bleeding.23,29
Reasons for Failure of Outpatient Hysteroscopy Failure is the inability to gain access and/or an adequate view during hysteroscopy. The most common reasons for failure are cervical stenosis, pain, and poor view. Other reasons are inability to visualize the cervix, vagal reaction, anxiety, extreme retroversion, and nonspecific technical problems. Some articles did not specify the reasons for failure.15–18 In those articles where reasons for failure were specified (in those who had a success rate between 90%–100%), 29.4% (72/245) of procedures failed because of pain, 28.2% (69/245) because of stenosis, and 20.8% (51/245) because of poor view, accounting for 78.4% of all failed procedures. In a cohort analysis of semirigid hysteroscopy, stenosis was the bigger problem (67.9% of failures), which the authors attributed to limiting the dilatation of the cervix to a No. 3 dilator in order to reduce patient discomfort.19 There was no trend toward increased failure in any one demographic group.
Reducing Pain: How Can the Success be Improved? The main factor affecting outcome in ambulatory hysteroscopy is pain. If we consider each component of the outpatient hysteroscopy to assess its contribution to overall pain, the majority of articles concluded that the grasping of
Table 1. Patient Acceptability of Outpatient Hysteroscopy
Analgesia None9 None21 None20 Intracervical block15 Paracervical block Uterosacral block11 Naproxen Sodium/transcervical block22 Topical gel/intracervical block Placebo/intracervical block17
No. of Patients
Preferring GA Next Operation No. (%) 89 (48) 189 (16.5) NS 8 (11.6) 1 (1.7) 2 (3.3) NS NS
185 1144 554 69 60 60 99 44 44
GA = general anesthesia; NS = not specified. aScore on a mean acceptability score, with 10 as maximum acceptability.
316
Acceptable
Problem
8.3a NS 84% NS NS
NS Intolerable pain Pain Pain NS
9.3–9.9a 84%
NS Pain
August 2004, Vol. 11, No. 3
The Journal of the American Association of Gynecologic Laparoscopists
a 22-gauge spinal needle at three, five, seven, and nine o’clock paracervically. The trial showed that there was a statistically significant improvement in pain control at insertion of the scope but at no other time during the procedure and that the injection was as painful as the procedure.30
the cervix by a tenaculum was a small but significant cause of pain,10,33 the instillation of local anesthetic can be “as painful as the rest of the procedure,”29,32 cervical dilatation was a significant cause of pain,18,28 insertion of the hysteroscope and the remainder of the procedure were equally painful, and the larger the diameter of the telescope used the more pain was caused.12, 29 There was no agreement as to whether normal saline or CO2 is more painful. In two studies, CO2 was less painful,15,24 and in one study, saline was less painful.27 The biopsy was as painful, or even more painful, than the procedure.9,29–31,34 The problem with comparing studies performed to date was a wide variation in the use of the speculum, tenaculum, dilatation of the cervix, and telescope size, from a 2.7-mm flexible scope to a 5-mm rigid telescope. Different distention media were used (CO2, normal saline, glycine) together with variable levels of intrauterine pressure. Not all studies performed or recorded the taking of an endometrial biopsy. When considering analgesic protocols, different amounts of analgesia were given, with variable waiting times before commencing the procedure, and different sized needles were used. All of these factors impacted on the pain experienced and its control. Pain assessments were also different, with different groups measuring pain at different points in the procedure.
Intracervical Block One-hundred women were randomized to receive either 10 mL of 1% lignocaine with adrenaline or 10 mL of saline injected using a 22-gauge needle into the cervix at one, five, seven, and 11 o’clock. No statistically significant difference in pain between the two groups was found. Sixty-five percent of the women rated the injection as painful or more painful than the rest of the procedure.32 Transcervical Block One-hundred women were randomized to receive either 5 mL of 2% lignocaine or normal saline via the channel of the hysteroscope at its introduction, followed by a wait of 2 minutes before commencing. The study found a trend to reduction of pain in the study group, reaching statistical significance at reducing the pain of endometrial biopsy in those who had not had a previous vaginal delivery or D&C or who were postmenopausal. All patients took naproxen sodium orally 1 hour before the procedure, and the cervix was sprayed with lignocaine. All pain scores were low, and it was thought that there might not have been a sufficient delay before commencing the procedure.22 In another study, 80 postmenopausal women were randomized to receive either 2 mL of 2% mepivacaine or saline by catheter 5 minutes preprocedure. The researchers found a statistically significant reduction in pain in the study group and fewer vagal reactions.12 Other researchers randomized 45 women to receive either 5 mL of 2% mepivacaine or saline 3 minutes preprocedure. Pain rated by an observer was statistically lower in the study group, and a trend toward decreased pain was reported by the subjects.13 In another study, 90 women were randomized to receive either 5 mL of 2% lignocaine or saline 5 minutes preprocedure. There was no difference in pain scores between the two groups.31
Anesthesia Paracervical Block One study randomized 181 premenopausal women to receive either no anesthesia or 10 mL of mepivacaine hydrochloride with a 22-gauge spinal needle at three, five, seven, and nine o’clock paracervically. There was no significant difference in pain scores between the groups. Potential confounders were that the two groups were not blinded to the administration of anesthesia, and there was no placebo injection control.34 Another study randomized 120 women to either 16–20 mL of 1% lignocaine as a paracervical block or 1 mL of 2% lignocaine into each uterosacral ligament. Both groups also received a small amount (0.5 mL) into the anterior lip before placement of the tenaculum. There was no difference between the two groups in pain scores.11 Other researchers randomized 362 postmenopausal women into one of three groups. They used a hysteroscope with a 5-mm sheath without anesthesia; a 5-mm sheath with 20 mL of 1% mepivacaine injected with a 21-gauge needle at three, five, seven, and nine o’clock paracervically; and a 3.5-mm hysteroscope without anesthesia. A statistically significant improvement in pain scores was obtained in the paracervical group compared with the 5-mm sheath, no-anesthesia group. The use of a 3.5-mm hysteroscope was associated with the lowest pain score (6.3/10 vs 5.3/10 vs 4.5/10). However, there was a decreased success rate with a smaller scope because of poor view. The arms were not blinded, and there was no placebo injection control.29 In another study, 100 women were randomized to 10 mL of 2% lignocaine or 10 mL of saline injected using
Topical Analgesia Eighty-eight women were randomized to receive either 10 mL of 2% lignocaine gel or placebo. A trend toward decreased pain was found if injection of local anesthetic was needed; otherwise, no difference in pain was found.17 In another study, 500 women were randomized to receive either 4 mL of 2% lignocaine gel or placebo. No difference in the pain between the two groups was found.31 In three other studies with a combined total of 541 women, a statistically significant benefit was found of applying lignocaine spray (either 30 mg, 50 mg, or 100 mg) to the cervix and cervical canal.28,33,35 One of the studies showed benefit at insertion and during the hysteroscopy, with decreased vasovagal reactions and shoulder tip pain;33 one in overall pain and decreased need for local anaesthetic;35 and one in pain from the tenaculum.28
317
Pain Relief and Outpatient Hysteroscopy Readman and Maher
In a study of 180 women, group A received a cream containing 25 mg of lignocaine and 25 mg of prilocaine, group B received 40 mg of lignocaine spray, and group C received no anesthetic. Both groups A and B showed a statistically significant decrease in pain at insertion and during the procedure and a decreased incidence of vasovagal reactions. In group A the hysteroscopy took less time, and there was a decreased incidence of tenaculum pain and shoulder tip pain. Compared with the spray, the cream was more effective in reducing pain during the procedure, but the cream made vision more difficult, needing to be wiped off the cervix and defogging spray applied to the telescope.14
6. Soares SR, Batista BR, Marcos M, et al: Diagnostic accuracy of sonohysterography, transvaginal sonography, and hysterosalpingography in patients with uterine cavity diseases. Fertil Steril 2000, 73:406–11.
Nonsteroidal Anti-Inflammatory Drugs Ninety-five women were randomized to receive 500 mg of naproxen or placebo 1 hour before the procedure. If there was discomfort during the procedure, intracervical lignocaine was used. The study showed a statistically significant reduction in pain at 30 and 60 minutes postprocedure with pharmacologic therapy.36
10. Bettocchi S, Selvaggi L: A vaginoscopic approach to reduce the pain of office hysteroscopy. J Am Assoc Gynecol Laparosc 1997, 4:255–8.
7. Rogerson L, Bates J: A comparison of outpatient hysteroscopy with saline infusion hysterosonography. Br J Obstet Gynaecol 2002, 109:800–4. 8. Habiba MA: Diagnostic accuracy of outpatient hysteroscopy. Am J Obstet Gynecol 1997, 176:1399–1400. 9. Lau WC, Ho RYF, et al: Patient’s acceptance of outpatient hysteroscopy. Gynecol Obstet Invest 1999, 47:191–3.
11. Finikiotis G, Tsocanos S: Outpatient hysteroscopy: A comparison of 2 methods of local analgesia. Aust NZ J Obstet Gynaecol 1992, 32:373–4. 12. Cicinelli E, Didonna T, Ambrosi G, et al: Topical anaesthesia for diagnostic hysteroscopy and endometrial biopsy in postmenopausal women: A randomised placebo-controlled doubleblind study. Br J Obstet Gynaecol 1997, 104:316–9.
Conclusion For the diagnosis and, in some cases, treatment of abnormal uterine bleeding ambulatory hysteroscopy is a safe, reliable alternative that is acceptable to patients when compared with hysteroscopy under general anesthetic. From available studies, it seems reasonable to use nonsteroidal anti-inflammatory drugs 1 hour preprocedure if not contraindicated, and topical analgesia (e.g., lignocaine spray) before the insertion of the hysteroscope. It would be logical to reserve the use of the tenaculum for difficult insertions, to use a paracervical block if dilatation is required, and try smaller hysteroscopes if larger ones fail. Whether saline or CO2 should be used routinely is not clear, and an endometrial biopsy should be reserved for specific indications. The use of other blocks is not proven, but may be useful in selected cases.
13. Zupi E, Luciano A, Valli E, et al: The use of topical anesthesia in diagnostic hysteroscopy and endometrial biopsy. Fertil Steril 1995, 63:414–6. 14. Zullo F, Pellicano M, Stigliani C, et al: Topical anesthesia for office hysteroscopy: A prospective randomized study comparing two modalities. J Reprod Med 1999, 44:865–9. 15. Cutner A, Erian J: Who should have an outpatient hysteroscopy? Gynaecol Endoscopy 1996, 5:231–4. 16. Lorino C, Prough S, Aksel S, et al: Pain relief in hysterosalpingography. A comparison of analgesics. J Reprod Med 1990, 35:533–536. 17. Clark S, Vonau B, Macdonald R: Topical anaesthesia in outpatient hysteroscopy. Gynaecol Endoscopy 1996, 5:141–44. 18. Wong AYK, Wong KS, Tang LCH: Stepwise pain score analysis of the effect of local lignocaine on outpatient hysteroscopy: A randomized, double-blind, placebo-controlled trial. Fertil Steril 2000, 73:1234–7.
References 1. Coulter A, McPherson K, Vessey M: Do British women undergo too many or too few hysterectomies? Soc Sci Med 1988, 27:987–94.
19. Salha O, Okeahialam M, Jones S, et al: Outpatient microhysteroscopy: Why does it fail? Gynaecol Endoscopy 2001, 10:167–71.
2. Gimpleson RJ, Rappold HO: A comparative study between panoramic hysteroscopy with directed biopsies and dilatation and curettage. Am J Obstet Gynecol 1988, 158:489–92.
20. Kremer C, Barik S, Duffy S: Flexible outpatient hysteroscopy without anaesthesia: A safe, successful and well tolerated procedure. Br J Obstet Gynaecol 1998, 105:672–6.
3. Loffer FD: Hysteroscopy with selective endometrial sampling compared with D&C for abnormal uterine bleeding: The value of a negative hysteroscopic view. Obstet Gynecol 1989, 73:16–20.
21. De Iaco P, Marabini A, Stefanetti M, et al: Acceptability and pain of outpatient hysteroscopy. J Am Assoc Gynecol Laparosc 2000, 7:71–5.
4. Badawy A, Ash F, Nagele H, et al: Ultrasonography, hysteroscopy or both? J Obstet Gynecol 1996, 16:551–5.
22. Costello MF, Horrowitz SD, Williamson M: A prospective randomised double-blind placebo controlled study of local anaesthetic injected through the hysteroscope for outpatient hysteroscopy and endometrial biopsy. Gynaecol Endoscopy 1998, 7:121–6.
5. Towbin NA, Israel MG, March CM: Office hysteroscopy versus transvaginal ultrasonography in the evaluation of patients with excessive uterine bleeding. Am J Obstet Gynecol 1996, 174:1678–82.
318
August 2004, Vol. 11, No. 3
The Journal of the American Association of Gynecologic Laparoscopists
23. Finikiotis G: Side-effects and complications of outpatient hysteroscopy. Aust NZ J Obstet Gynaecol 1993, 33:61–2.
31. Lau WC, Tam WH, Lo W, et al: A randomised double-blind placebo-controlled trial of transcervical intrauterine local anaesthesia in outpatient hysteroscopy. Br J Obstet Gynaecol 2000, 107:610–3.
24. Bellingham FR: Outpatient hysteroscopy: Problems. Aust NZ J Obstet Gynaecol 1997, 37:202–5.
32. Broadbent JAM, Hill NCW, Molnar B, et al: Randomised placebo controlled trial to assess the role of intracervical lignocaine in outpatient hysteroscopy. Br J Obstet Gynaecol 1992, 99:777–80.
25. De Jong P, Doel F, Falconer A: Outpatient diagnostic hysteroscopy. Br J Obstet Gynaecol 1990, 97:299–303. 26. Hill NCW, Broadbent JAM, Magos AL: Local anaesthesia and cervical dilatation for outpatient diagnostic hysteroscopy. J Obstet Gynaecol 1992, 12:33–7.
33. Davies A, Richardson RE, O’Connor H, et al: Lignocaine aerosol spray in outpatient hysteroscopy: A randomised double-blind placebo-controlled trial. Fertil Steril 1997, 67:1019–23.
27. Nagele F, O’Connor H, Davies A, et al: 2500 outpatient diagnostic hysteroscopies. Obstet Gynecol 1996, 88:87–92. 28. Soriano D, Ajay S, Chuong T, et al: Lidocaine spray and outpatient hysteroscopy: Randomized placebo-controlled trial. Obstet Gynecol 2000, 96:661–4.
34. Vercellini P, Colombo A, Mauro F, et al: Paracervical anesthesia for outpatient hysteroscopy. Fertil Steril 1994, 62:1083–5.
29. Giorda G, Scarabelli C, Franceschi S, et al: Feasibility and pain control in outpatient hysteroscopy in postmenopausal women: A randomised trial. Acta Obstet Gynecol Scand 2000, 79:593–7.
35. Wieser F, Kurz C, Wenzl R, et al: Atraumatic cervical passage at outpatient hysteroscopy. Fertil Steril 1998, 69:549–51. 36. Nagele F, Lockwood G, Magos AL: Randomised placebo controlled trial of mefanamic acid for premedication at outpatient hysteroscopy: A pilot study. Br J Obstet Gynaecol 1997, 104:842–4.
30. Lau WC, Lo WK, Tam W, et al: Paracervical anaesthesia in outpatient hysteroscopy: A randomised double blind placebocontrolled trial. Br J Obstet Gynaecol 1999, 106:356–9.
319