McDonald cerclage under pudendal nerve block

McDonald cerclage under pudendal nerve block

McDonald cerclage under pudendal nerve block Brian McCulloch, MD, Suzanne Bergen, MD, Bruce Pielet, MD, James Keller, MD, and Haim Elrad, MD Park Rid...

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McDonald cerclage under pudendal nerve block Brian McCulloch, MD, Suzanne Bergen, MD, Bruce Pielet, MD, James Keller, MD, and Haim Elrad, MD

Park Ridge, Illinois OBJECTIVE: The purpose of our study was to evaluate McDonald cerclage placement with pudendal anesthesia. Patient pain and hospital charges were analyzed and compared with a control group. STUDY DESIGN: This was a prospective, nonrandomized study. Pain was evaluated with a visual analog scale. Two groups were compared with the Student t test. RESULTS: Of 69 patients, 20 had cerclage with pudendal anesthesia; 49 served as control and had cerclage with regional anesthesia. There were no statistical differences in pain between the two groups or complications from pudendal anesthesia, and there was a large cost savings. CONCLUSION: All 20 patients had McDonald cerclage placed successfully with pudendal anesthesia. McDonald cerclage can be easily and safely placed under pudendal anesthesia, resulting in cost savings and improved use of time and resources for the patient and her physician. (AM J OBSTET GYNECOL 1993;168:499-502.)

Key words: McDonald cerclage, pudendal nerve block, incompetent cervix

The McDonald cerclage has gradually become the most commonly used surgical procedure for incompetent cervix. 13 To place the McDonald cerclage there must be adequate anesthesia to relieve pain and provide perineal relaxation so that the anatomic landmarks can be clearly felt and the suture appropriately placed.' The choice of anesthetics has been either general or regional anesthesia, both of which require an anesthesiologist's expertise and have potential for significant complications." Pudendal nerve block is a simple, inexpensive, and safe procedure generally used for relief of pain and perineal relaxation in the second stage of labor. The anesthetic action is rapid, predictable, and has a short duration of effect without the associated hypotensioninduced vomiting and retching." Our study evaluated the use of pudendal nerve block for the relief of pain and perineal relaxation for McDonald cerclage as compared with regional anesthesia.

Material and methods The subjects included in this prospective, nonrandomized study were consecutive patients diagnosed as having incompetent cervices whose cerclages were

From the Division of Maternal-Fetal Medicine, Department of Obstetrics and Gynecology, Lutheran General Hospital. Supported by a grant from the Lutheran General Medical Group Foundation. Received for publication April 29, 1992; revised June 18, 1992; acceptedJune 30, 1992. Reprint requests: Brian P. McCulloch, MD, Division of MaternalFetal Medicine, Department of Obstetrics and Gynecology. Lutheran General Hospital, 1775 Dempster, Park Ridge, IL 60068. Copyright © 1993 Mosby-Year Book, Inc. 0002-9378/93 $1.00 + .20 6/1/40719

placed at Lutheran General Hospital, Park Ridge, Illinois, between Jan. 1, 1991, and March I, 1992. Lutheran General Hospital is a tertiary care center in an affluent suburb of Chicago. There are approximately 5000 deliveries a year, and high-risk referrals are from seven network hospitals. Our study was reviewed and approved by the Institutional Review Board of Lutheran General Hospital for experimentation on human subjects. Subjects were recruited into one of two groups: Group I, patients who received pudendal anesthesia, were recruited from the Perinatal Center, which is staffed by four hospital-based perinatologists. Patients cared for by the Perinatal Center were in need of cerclage and were at < 18 weeks' gestation; they were enrolled in this arm of the study after informed consent was obtained. Ninety percent of the cerclages were placed by B.McC. Group 2, patients who received regional anesthesia for cerclage placement during this same time interval, were recruited to serve as controls. Twelve physicians placed the cerclages in this group. Regional anesthesia is the standard treatment for pain relief and pelvic relaxation for cerclage placement at Lutheran General. Five patients at > 18 weeks' gestation were included in this group. Group I patients had transvaginal pudendal anesthesia described to them in lay terms, and informed consent was obtained. The patients were admitted to the Labor and Delivery Department, and an intravenous line was started. Each patient voided before transfer to a delivery room and placement in the dorsal lithotomy position. No preoperative anxiolytic medication or analgesia was used. Each patient was draped in a sterile fashion, and the perineum was prepared with warm Betadine. The vagina was examined and prepared with

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Table I. Indications for McDonald cerclage placement Anesthesia

Indications

History consistent with incompetent

Pudendal

Regional

No·1 %

No·1 %

7

35

15

31

7 3 1

35 15 5

10 9 4

20 18 8

0 1 1 0

0 5 5 0

3 3 0 5

6 6 0 10

cervix

Previous cerclage Short or "threatening" cervix History of diethylstilbestrol exposure Prophylactic (multiple gestations) Previous cone biopsy history Cervical laceration Emergency cerclage (gestational > 18 wk) TOTAL

20

49

warm Betadine. The ischial spine was located, and a protective trumpet sheath intramucosal and submucosal infiltration with lidocaine was performed with a 15 em, 20-gauge needle. The needle was advanced through the sacrospinous ligament, and :s; 10 em' of 1% lidocaine was used." Aspiration was always performed before injection to prevent inadvertent vascular injection. The needle was removed, and the same procedure was performed on the opposite side. A weighted speculum was placed in the vagina, and vaginal retraction was performed with a Sims retractor. The cervix was grasped anteriorly and posteriorly with an Allis clamp, which was chosen to minimize trauma to the cervix and to avoid inadvertently passing the suture through a ring forcep. Long Russian forceps were used to stabilize the tissue, where the needle entered or exited only as necessary. Four to five passes of the needle were needed to complete the cerclage. The 5 mm Mersilene band was tied anteriorly and trimmed. No tocolytic or antibiotic prophylaxis was used. No anesthesiologist was present, and a nurse served as the patient support and contact person throughout the procedure. Group 2 patients were also admitted to the Labor and Delivery Department and were transported into the delivery room. All regional anesthesia was performed by board-certified anesthesiology attending physicians in the operating room. Once an adequate level of anesthesia was achieved, the patients were placed in the dorsal lithotomy position and examined by the attending obstetrician. Once pelvic relaxation and anesthesia were judged to be adequate, the McDonald cerclage was placed as per the individual physician. Patients in both groups were given a questionnaire within 2 hours of completion of the procedure and were asked to rate their pain at three different time periods: (1) pain from the pelvic examination, (2) pain from the

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anesthetic placement, and (3) pain from the cerclage placement. The questionnaire consisted of a Visual Analogue Scale, which was a 10 em line anchored at one end by the label "no pain" and at the other end by the label "worst imaginable pain." Verbal descriptors were spread along the entire length of the horizontal line. Patients were asked to place a mark at the level of intensity of their pain. The respondents almost universally placed their pain into one of four areas. Once the study was completed, the Visual Analogue Scale was tabulated from 0 to 3, and the two groups were compared by using the Student t test. The Visual Analogue Scale is a simple and efficient self-report of pain intensity that has no descriptive bias." " Results

Of the 69 consecutive cerclage patients in this study, 20 patients (group 1) had their cerclages placed with pudendal anesthesia. One patient refused participation in the pudendal anesthesia group because she had a prior successful cerclage under regional anesthesia. She had regional anesthesia and was included in group 2. All patients had been informed that if pain relief was inadequate regional anesthesia would be used. None of these 20 patients requested additional pain relief, and no other analgesia was used. Forty-nine patients had cerclages placed with regional anesthesia (group 2). Four had spinal anesthesia, and the remaining 45 had epidural blocks. The average maternal age for group 1 was 31 years, with a range of 22 to 41 and a median age of 30. Group 2 also had an average age of 31, with a range of 19 to 39 and a median age of 31. The average gestational age for group 1 was 14.3 weeks (range 12 to 18), and group 2 patients averaged 16 weeks (range 12 to 24). The indications for cerclage placement are listed in Table 1. The most frequent indication for cerclage placement was a history consistent with incompetent cervix. Nineteen of the 20 patients III group 1 have been delivered (95%). The other patient is at 29 weeks and having no complications. Sixteen patients were delivered after 35 weeks' gestation and had an unremarkable course in the newborn nursery. There were no small-for-gestational-age babies, nor were any congenital anomalies noted during their hospital stay. Three patients in group 1 had spontaneous rupture of membranes at < 25 weeks' gestation. These patients were examined at the time of rupture, and the cerclage was found to be intact with appropriate placement. The ruptures occurred 3 weeks after cerclage placement in one patient and 8 weeks after placement in the other two patients. These were high-risk patients with poor obstetric histories (Table II). No infectious, vascular, or neurologic complications were associated with the pudendal block.

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Table II. Patients with spontaneous rupture of membranes at < 25 weeks' gestation Patient No.

Age (yr)

Pudendal anesthesia 1 34 2 34

3

22

Regional anesthesia 4 28

Week.I, gestation at cerclage

Weeki-at rupture 0/ membranes

Gravidity

Parity

Indications for crrclag«

6 8

0-2-3-0 0-2-5-0

16 12

24 20

3

0-2-0-2

2 Previous second-trimester losses 2 Previous second-trimester losses, 1 previous cerclage 2 Previous preterm deliveries with prolonged hospitalization for "threatening" or short cervix

18

21

3

1-0-1-1

"Threatening" cervix, dilated 2cm Diethylstilbestrol exposurefibroid uterus 5 Spontaneous abortionsshort cervix

23

24

16

19

16

22

5

38

3

0-0-2-0

6

36

7

1-0-5-1

Of the 49 patients in the regional anesthesia group, 47 have been delivered (96%). The two undelivered patients are at 30 and 31 weeks and are having no problems. Three patients had spontaneous rupture of membranes at < 25 weeks (Table II). Three additional patients were delivered at < 30 weeks, and five were delivered at between 31 and 34 weeks' gestation. The remaining 36 were delivered at > 35 weeks' gestation. No complications from the regional anesthetic were noted. The patients were given a pain questionnaire within 2 hours of completion of the procedure. They recorded their pain intensity on a Visual Analogue Scale at three different periods. Their responses were later quantified from 0 to 3, with 0 being no pain and 3 being the worst imaginable (Table III). Both groups noted the anesthetic placement as the most painful of any of the three time periods evaluated. The Student t test showed no statistical difference between the two groups at the 0.05 level. The test had a power of 0.95 to detect a I-point scale difference. Comment

Our study shows that McDonald cerclage can be successfully placed with pudendal anesthesia for pelvic relaxation and pain relief. No patients required additional medications or requested a change to regional anesthesia. The only difference between the groups that approached statistical significance was the increased pain associated with the preoperative pelvic examination in the pudendal group. The pelvic examination in this group was more extensive because of the necessity of identifying the landmarks for anesthetic placement. There were no complications in the immediate perioperative period, and all but one patient has been delivered. The patients who had pudendal anesthesia were at high risk and had previously had poor obstetric

Table III. Average pain score (scale 0 to 3) for patients undergoing McDonald cerclage Anesthesia Pudendal

Pain with pelvic examination Pain with anesthetic placement Pain with cerclage placement

I

Regional

p Value

0.84 ± 0.49

0.57 ± 0.66

0.11

1.74 ± 0.56

1.70 ± 0.68

0.85

1.06 ± 0.91

1.02 ± 0.90

0.86

Values are mean ± SD.

outcomes. That three patients had ruptured membranes 3 to 8 weeks after the procedure is cause for concern but does not reach statistical significance (P = 0.35 by the Fisher exact test). Two of these three patients had prior cerclages and regional anesthesia with antecedent pregnancies and also had ruptured membranes before viability. No preliminary or pilot study supports pudendal block for cerclage placement; therefore other physicians were uncomfortable allowing their patients to be randomized. The rupture of membranes is probably more related to the nonrandom allotment of patients than to anesthetic technique. The use of pudendal anesthesia made cerclage placement more convenient for the physician and the patient because the physician can schedule the case without an anesthesiologist. The pudendal anesthetic effect is rapid in action, so there is minimal time spent waiting for effect. There is no associated hypotension that could lead to nausea and retching and possibly a disastrous outcome during or after the procedure. There is no operative delay caused by other anesthetic or obstetric emergencies. The anesthetic effect is of short duration; this allowed the patient to be mobile and to maintain

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full control of her bladder function, and it shortened her hospital stay. Recently there was a report of successful McDonald cerclages performed in an ambulatory surgery setting." Pudendal anesthesia would be the perfect anesthesia because of the short duration of action and the minimal effect on muscular function. Our study is continuing and has been moved to an ambulatory surgery setting. There is potential for a tremendous cost savings by using pudendal anesthesia. The time necessary to complete the procedure is generally < 20 minutes, and there is no recovery time necessary. The obstetrician places the pudendal anesthetic, so there is no need for an anesthesiologist's expertise. Unfortunately, in our study there is a minimum charge of 1 hour for use of the operating room; because of protocol, all patients must go to the recovery room. Despite these requirements, pudendal anesthesia for cerclage placement resulted in a cost savings of > $500 per patient. By using the ambulatory surgery facilities, the price could be halved. Pudendal nerve block is a viable option for patients and physicians, and it makes better use of time and resources.

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REFERENCES

1. Cromblehome WR, Minkoff HL, Deike I, Schwarz RH. Cervical cerclage: an aggressive approach to threatened or recurrent pregnancy wastage. AM J OBSTET GYNECOL 1983; 146:168-74. 2. Golan A, Raman R, Wexler S, Langer R, Bukovsky I, David MP. Incompetence of the uterine cervix. Obstet Gynecol Surv 1989;44:96-107. 3. Harger JH. Comparison of success and morbidity in cervical cerclage procedures. Obstet Gynecol 1980;56:543-8. 4. McDonald IA. Suture of the cervix for inevitable miscarriage. J Obstet Gynaecol Br Emp 1957;64:346-50. 5. Albright GA. Paracervical, pudendal and perineal field blocks. In: Albright GA, Ferguson JE II, Joyce TH III, et al. Anesthesia in obstetrics: maternal, fetal and neonatal aspects. Woburn, Massachusetts: Butterworth, 1986:21225. 6. Cunningham GF, MacDonald PC, Gant NF. Analgesia and anesthesia. In: Williams' obstetrics. 18th ed. Norwalk, Connecticut: Appleton and Lange, 1989:327-40. 7. Bonica JJ, Loeser JD, Chapman CR, Fordyce WE. The management of pain. Philadelphia: Lea & Febiger, 1990: 580-609. 8. Wewers ME, Lowe MK. A critical review of Visual Analog Scales in the measurements of clinical phenomena. Res Nurs Health 1990;13:227-36. 9. Wetchler BV, Brick J. Safety of outpatient cerclage. J Reprod Med 1990;35:243-6.