Preoperative Levator Ani Muscle Injection and Pudendal Nerve Block for Pain Control After Vaginal Reconstructive Surgery

The primary purpose of this three arm, randomized clinical trial is to test the hypothesis
that preoperative injections along the levator ani muscles and pudendal nerve with
bupivacaine and dexamethasone improve pain control after vaginal native tissue apical
reconstructive surgery.

Hypothesis: concurrent bilateral transobturator levator ani muscle injections and
transvaginal pudendal nerve blocks with bupivacaine and dexamethasone performed prior to
vaginal apical support procedures will result in improved pain scores at 24 hours
postoperatively.

Participants will be randomized to three arms: bupivacaine/dexamethasone group, bupivacaine
group, and placebo group. Block randomization will occur and will be stratified by surgery
type to ensure that similar numbers of each procedure are randomized to each study arm.

All 3 groups will receive pudendal nerve blocks and transobturator levator ani muscle
injections as outlined in detail below (with either bupivacaine/dexamethasone, bupivacaine
alone or saline depending on randomization). The interventions will be performed after the
participant is positioned in lithotomy position and after sterile preparation of the vagina
and perineum per standard protocol. These injections will be performed at the start of the
procedure prior to any vaginal repair and be administered by either the attending surgeon or
the urogynecology fellow. After the interventions below, the vaginal reconstructive
procedures will be performed as usual by the attending surgeon and surgical team. There are
both fellows and residents who participate in these vaginal reconstructive surgeries, however
for study purposes, resident physicians will not be permitted to administer either the
pudendal nerve block or the transobturator injections. There are four attending surgeons and
four fellow physicians who will be administering the injections. While all surgeons are
familiar with the anatomy and have performed these procedures, each physician will be
instructed on the intended procedures and additionally will be directly observed in the
operating room for at least one procedure to ensure consistency in technique. All
participants will undergo a standardized general anesthesia regimen.

After the study intervention, all participants will then undergo the scheduled vaginal
reconstructive procedure as standard. Infiltration of the vaginal epithelium with lidocaine
is common in vaginal repairs. The maximum doses of lidocaine and bupivacaine are additive.
The amount of local infiltration to 50 milliliters of 0.5% lidocaine with epinephrine. This
dose is equal to 250mg of lidocaine which, when also taking into account the 50mg of
bupivacaine, is within a safe dosing range for a participant weighing 50kg.

Administration of all four injections involved in the study protocol and described above take
approximately 5 additional minutes in total at the start of the case. After the injections
are performed, there will be no further interventions.

Other assessments that will be performed as part of the study protocol are outlined below:

Baseline assessments: Pain assessment, assessment of presence of any baseline nausea or
vomiting, baseline activities assessment will all be performed in preoperative area on the
day of surgery prior to randomization.

Postoperative pain score assessment: 3 hours, 24 hours, 48 hours, 72 hours, and 1 week
postoperatively. Postoperative pain measured by the numerical rating scale (NRS). The NRS is
a publicly available pain assessment tool that consists of an eleven point scale ranging from
0 to 10 (0 = no pain and 10 = worst possible pain) presented visually on a horizontal line.
Participants are asked to report a number or mark on the scale. Previous studies have
demonstrated its reliability, validity and ease of administration. The NRS was chosen because
a systematic review article demonstrated higher compliance rates, better responsiveness and
ease of use relative to visual analog scales. Additionally, the NRS has been shown to have
strong validity and low error rates when used in an elderly (>60 years) postoperative patient
population.

Postoperative nausea and vomiting assessment: 3 hours postoperatively The intensity of
postoperative nausea and vomiting (PONV) using the PONV Intensity scale. The PONV scale is a
four question assessment designed to measure clinically significant nausea and vomiting. It
was initially validated in a general surgery population and has been validated in early
postoperative gynecology patients. Clinically important nausea and vomiting is defined as a
score greater than or equal to 50. This scale takes approximately 1 minute to complete and is
publicly available. The amount of inpatient anti-emetic consumption will also be assessed.
Any anti-emetic administered from surgery end time will be recorded as well as the dosage.
Anti-emetic type and dosage will be recorded until the time of discharge.

Voiding status at time of foley catheter removal. All patients routinely have some assessment
of voiding function prior to discharge. Whether each participant passed or failed a voiding
trial after surgery will be recorded in the database. If a participant fails, the standard of
care is do be discharged to home after learning self-catheterization or with a foley
catheter. In the event that a participant fails a postoperative voiding trial, whether
participants receive a foley catheter or were performing self-catheterization will be
recorded. As this is a routine part of postoperative care, the research protocol will not
interfere with the performance or outcomes of a voiding trial. Results will be documented,
however no specific assessment tool will be used.

Time to resume normal activities measured by the activities assessment scale (AAS): 1 week, 2
weeks, 6 weeks and 12 weeks postoperatively The AAS was initially designed to assess
functional activity in the perioperative period in the general surgery population. It has
since been deemed a valid and reliable measure to assess postoperative activity level in a
Female Pelvic Medicine and Reconstructive Surgery patient population. It has the ability to
measure perioperative function and takes approximately 3-5 minutes to complete. It consists
of a 13 item questionnaire assessing various types of physical activity and the degree of
difficulty associated with each activity. The types of activities assessed fall into three
subscales: sedentary activities (questions 1-4), ambulatory activities (questions 6-8), and
work or exercise activities (questions 11-13). Respondents also have the option to indicate
that these activities were not performed for another indication (this item is not scored).
The time frame for all questions is the previous 24 hours. Given that many patients are
instructed to avoid strenuous work or exercise activity in the postoperative period, the
subscales of sedentary activities and ambulatory activities, which patients are encouraged to
perform as tolerated in the postoperative period, will be of most interest.

Consumption of analgesic medications: during inpatient hospital stay and for first 72 hours
postoperatively Narcotic consumption will be measured in morphine equivalents. The amount of
narcotics will be obtained from the inpatient hospital record. All narcotics received from
the surgery end time to the time of discharge will be included. Morphine equivalents will be
calculated with online calculator available at
http://www.agencymeddirectors.wa.gov/Calculator/DoseCalculator.htm. Similarly, the amount of
NSAIDs will be obtained from the inpatient hospital record. All NSAIDs received from the
surgery end time to the time of discharge will be included. To assess both the amount of
narcotic and NSAID consumption after discharge, the participant will be provided with a diary
form to record how many daily tablets of narcotic and NSAIDs are taken. This form will be
completed from postoperative days 1-3.

For all forms, the participants will be instructed to mail the forms back to the office once
completed (in a pre-address envelope provided as part of the study). Participants will also
have the option of brining the forms in to the office at the time of a participant's
postoperative visit.

Participants, physicians and any nursing personnel involved in patient care will remain
masked until 12 weeks postoperatively.

Inclusion Criteria:

1. Women ages 18 or older who are scheduled for a vaginal native tissue repair with
apical support procedure including uterosacral ligament suspension, sacrospinous
ligament fixation, or colpectomy and colpocleisis with or without levator myorrhaphy

2. Concomitant procedures including hysterectomy, anterior and posterior colporrhaphies ,
perineorrhaphies and midurethral sling placements are acceptable and do not result in
exclusion

3. Available for at least 12 weeks of follow-up

4. Able to undergoing general anesthesia

Exclusion Criteria:

1. Planned mesh-augmented apical support procedure (placement of synthetic midurethral
sling is acceptable and not considered an exclusion criteria)

2. Planned mesh excision

3. Laparoscopic, robotic or abdominal surgery

4. Known adverse reaction or allergy to intervention medication

5. Evidence of fistula or known infection (vulvovaginal cellulitis, abscess,
abdominopelvic infection, or systemic fungal infection)

6. Chronic pelvic pain as an active issue

7. Daily opiate consumption for any indication

8. History of pelvic radiation

9. Chronic steroid use

10. Diabetes mellitus

11. Known HIV/AIDS or immunosuppression secondary to transplant related medications

12. Planned surgery under regional anesthesia

13. Non-English speaking or inability to complete questionnaires

14. Bleeding disorders that would impair a patient's clotting ability

15. Weight less than 50kg