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:
Participant gender:
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).