Phase 2 N=75 Randomized Quadruple-blind Treatment

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

Pelvic Organ Prolapse · Surgery · Postoperative Pain

Bottom Line

View on ClinicalTrials.gov: NCT03040011 ↗

Enrolled (actual)

Serious AEs

4.0%

Results posted

Mar 2020

Primary outcome: Primary: Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS) — 3.0; 4.0; 3.75 score on a scale — p=0.39

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Dexamethasone (Drug); Bupivacaine (Drug); Bilateral Pudendal Nerve Block (Procedure); Bilateral Levator Ani Muscle Injection (Procedure); Saline (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Lauren Giugale, MD
Primary completion: Apr 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Primary Postoperative Pain Measured by the Numerical Rating Scale (NRS)	3.0; 4.0; 3.75	0.39
SECONDARY 6 Hour Postoperative Pain Measured by the NRS	1.0; 3.0; 1.75	0.25
SECONDARY POD 2 Postoperative Pain Measured by the NRS	3.0; 3.0; 4.0	0.17
SECONDARY POD 3 Postoperative Pain Measured by the NRS	3.0; 2.5; 3.5	0.45
SECONDARY 1 Week Postoperative Pain Measured by the NRS	1.75; 2.0; 1.0	0.54
SECONDARY Proportion of Patients With Same Day Discharge	20; 22; 20	0.80
SECONDARY Postoperative Urinary Retention	13; 11; 14	0.72
SECONDARY Adverse Events	7; 6; 9	0.64
SECONDARY Nausea and Vomiting Measured by the PONV Scale	0; 0; 0	0.41
SECONDARY Anti-emetic Consumption	—	—
SECONDARY Return to Baseline Activities Using the Activities Assessment Scale	21; 19; 18	0.19
SECONDARY Return to Baseline Activities Using the Activities Assessment Scale	21; 19; 18	0.19
SECONDARY Return to Baseline Activities Using the Activities Assessment Scale	21; 19; 18	0.19
SECONDARY Return to Baseline Activities Using the Activities Assessment Scale	21; 19; 18	0.19
SECONDARY POD 1 Narcotic Consumption	7.5; 4.4; 7.5	0.35
SECONDARY POD 2 Narcotic Consumption	7.5; 0.0; 7.5	0.32
SECONDARY POD 3 Narcotic Consumption	7.5; 0.0; 0.0	0.18
SECONDARY POD 1 Ibuprofen Consumption	1200; 1200; 1200	0.68
SECONDARY POD 2 Ibuprofen Consumption	1200; 1200; 1800	0.40
SECONDARY POD 3 Ibuprofen Consumption	1200; 1200; 1800	0.44

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).

Eligibility Criteria

Inclusion Criteria

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
Concomitant procedures including hysterectomy, anterior and posterior colporrhaphies , perineorrhaphies and midurethral sling placements are acceptable and do not result in exclusion
Available for at least 12 weeks of follow-up
Able to undergoing general anesthesia

Exclusion Criteria

Planned mesh-augmented apical support procedure (placement of synthetic midurethral sling is acceptable and not considered an exclusion criteria)
Planned mesh excision
Laparoscopic, robotic or abdominal surgery
Known adverse reaction or allergy to intervention medication
Evidence of fistula or known infection (vulvovaginal cellulitis, abscess, abdominopelvic infection, or systemic fungal infection)
Chronic pelvic pain as an active issue
Daily opiate consumption for any indication
History of pelvic radiation
Chronic steroid use
Diabetes mellitus
Known HIV/AIDS or immunosuppression secondary to transplant related medications
Planned surgery under regional anesthesia
Non-English speaking or inability to complete questionnaires
Bleeding disorders that would impair a patient's clotting ability
Weight less than 50kg

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03040011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.