Phase 4 N=45 Randomized Quadruple-blind Prevention

Gabapentin for Postop Pain After SSLF

Pelvic Organ Prolapse

Bottom Line

View on ClinicalTrials.gov: NCT03123861 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2020

Primary outcome: Primary: Pain During Normal Activities (Surgical Pain Scale Item 2) — 1.6; 3.2 units on a scale — p=0.09

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Gabapentin (Drug); Placebo oral capsule (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: University of North Carolina, Chapel Hill
Primary completion: Jul 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain During Normal Activities (Surgical Pain Scale Item 2)	1.6; 3.2	0.09
SECONDARY Gluteal Pain During Normal Activities	2.1; 3.4	0.09
SECONDARY Worst Pain (Surgical Pain Scale Item 4)	2.4; 4.0	0.08
SECONDARY Daily Narcotic Use	1.6; 1.6	0.91

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.

Eligibility 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

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Data sourced from ClinicalTrials.gov (NCT03123861). 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.