Gabapentin for Postop Pain After SSLF

NCT03123861 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 16-3392
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pelvic Organ Prolapse

Keywords

Pelvic Organ Prolapse; postoperative gluteal pain; opioid use

Outcome Measures

Primary Outcomes (1)

• Pain During Normal Activities (Surgical Pain Scale Item 2)

  Post-operative pain at week 1 will be measured by item 2 of the surgical pain scale (SPS). This item asks for the average amount of pain felt during normal activity in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain.

  7 days after surgery

Secondary Outcomes (3)

• Gluteal Pain During Normal Activities

  7 days after surgery

• Worst Pain (Surgical Pain Scale Item 4)

  7 days after surgery

• Daily Narcotic Use

  First 14 days after surgery

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg twice a day (BID) for an additional 11 days.

Drug: Gabapentin

Placebo oral capsule

PLACEBO COMPARATOR

Participants will take placebo for the 2 weeks after surgery.

Drug: Placebo oral capsule

Interventions

Gabapentin DRUG

Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.

Also known as: neurontin

Gabapentin

Placebo oral capsule DRUG

Patients randomized to this arm will receive 2 weeks of placebo post-operatively..

Also known as: Placebo

Placebo oral capsule

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Related Publications (1)

• Wu JM, Dieter AA, Feliciano KM, Geller EJ, Willis-Gray M. Randomized Clinical Trial of Gabapentin Versus Placebo for Pain After Sacrospinous Ligament Fixation. Female Pelvic Med Reconstr Surg. 2022 Feb 1;28(2):65-71. doi: 10.1097/SPV.0000000000001064.

  PMID: 35084369 DERIVED

MeSH Terms

Conditions

Pelvic Organ Prolapse

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Prolapse; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Jennifer Wu, MD, MPH, Professor of OBGYN
• Organization: University of North Carolina at Chapel Hill

jennifer_wu@med.unc.edu

919-966-0014

Study Officials

• Jennifer Wu, MD, MPH

  UNC Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 26, 2017
• First Posted: April 21, 2017
• Study Start: June 1, 2017
• Primary Completion: July 25, 2020
• Study Completion: July 25, 2020
• Last Updated: October 26, 2020
• Results First Posted: October 26, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)