Gabapentin for Postop Pain After SSLF

• Status: Completed
• Trial end date: 2020-07-25
• Target enrollment: 0
• Participant gender: Female

Summary

Purpose: To assess the impact of gabapentin versus placebo on overall postoperative pain and gluteal pain at 7 days after vaginal sacrospinous ligament suspension for apical pelvic organ prolapse.

Participants: English-speaking women planning to undergo a vaginal SSLF. Concurrent procedures can be performed except total vaginal hysterectomy, colpocleisis, anal sphincteroplasty, fistula surgery, or urethral diverticulectomy

Procedures (methods): Patients will be randomized to receive either 2 weeks of gabapentin or placebo for 2 weeks post-operatively. Standard of care pain medications will be given to both groups. Patients will be followed for 6 weeks post-operatively.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of North Carolina, Chapel Hill
• Treatments: Gabapentin; gamma-Aminobutyric Acid

Criteria

Inclusion Criteria:

• Women age 18+

• English-speaking

• Planning to undergo a vaginal SSLF

Exclusion Criteria:

• Pregnant or planning to become pregnant during study participation

• Prior vaginal mesh surgery for pelvic organ prolapse

• Planning a concurrent total vaginal hysterectomy, colpocleisis (total vaginectomy or LeFort colpocleisis), mesh excision, anal sphincteroplasty, fistula repair, or urethral diverticulectomy

• Cognitive impairment (indicated by a score of 0-2 on Mini-Cog)

• Currently taking gabapentin or pregabalin (Lyrica) or previous intolerance to gabapentin or pregabalin

• Daily use of narcotics for ≥ 2 months

• Acute or chronic renal failure based on past medical history (PMH) or glomerular filtration rate (GFR) < 30ml/min (see meds info below)

• Severe uncontrolled depression or bipolar disease based on PMH

• Fall risk if history of fall in last year or current use of cane/walker