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

• Status: Completed
• Trial end date: 2019-08-05
• Target enrollment: 0
• Participant gender: Female

Summary

To test the hypothesis that preoperative injections along the levator ani muscles and pudendal nerve with bupivacaine and dexamethasone improve pain control after vaginal apical reconstructive surgery. A three-arm, double-blinded, randomized controlled trial of a total of 75 women will be performed.

The study population will be adult women (>18 years of age) with uterovaginal or vaginal vault prolapse who have been scheduled for native tissue vaginal reconstructive surgery which includes an apical support procedure. Participants will be enrolled prior to surgery. The procedure will involved four injection sites: the bilateral levator ani muscles via a transobturator approach and bilateral pudendal nerves via a transvaginal approach. Random assignment will occur to one of three study arms: combined arm (20 milliliters bupivacaine/dexamethasone solution divided between the 4 injection sites), bupivacaine arm (20 milliliters bupivacaine divided between the 4 injection sites), or placebo arm (20 milliliters saline divided between the 4 injection sites).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Lauren Giugale, MD; University of Pittsburgh
• Collaborator: Magee-Womens Research Institute
• Treatments: BB 1101; Bupivacaine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate; Pharmaceutical Solutions

Criteria

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