Gabapentin for Postop Pain After SSLF

Completed · Phase 4 · Has a placebo group

Conditions studied: Pelvic Organ Prolapse

In brief

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.

Key facts

Study ID

NCT03123861

Run by

University of North Carolina, Chapel Hill

People needed

45

Starts

2017-06-01

Expected to finish

2020-07-25

Last updated by the study team

2020-10-26

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Women age 18+
• English-speaking
• Planning to undergo a vaginal SSLF

You may not qualify if…

• 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

Where it is running

• UNC Chapel Hill — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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