Gabapentin for Postop Pain After SSLF

NCT ID: NCT03123861

Last Updated: 2020-10-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 45 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-01
• Study Completion Date: 2020-07-25

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.

Detailed Description

Pelvic organ prolapse (POP), the herniation of the bladder, uterus, or rectum, into and often beyond, the vaginal opening, affects 40% of postmenopausal women and significantly impairs quality of life. POP is often managed surgically, and currently, one in every eight women will undergo POP surgery during her lifetime.

A commonly performed procedure for POP is a sacrospinous ligament fixation (SSLF), which is a vaginal surgery that involves suspending the vaginal apex to the sacrospinous ligament suspension with sutures. Beyond routine postoperative pain, a sacrospinous ligament fixation may result in significant gluteal pain as a result of the vaginal sutures affecting/impinging on the sacral nerve roots. Unfortunately, postoperative gluteal pain is not uncommon with 12% of patients reporting significant gluteal pain and 4% having persistent pain 6 weeks after surgery.

This study aims to compare the impact of gabapentin versus placebo on postoperative pain after SSLF. The rationale is that studies have shown that preoperative gabapentin, a non-opioid analgesic, resulted in a lower narcotic use postoperatively. Decreasing the use of standard of care postoperative narcotic pain medications would also decrease adverse events due to narcotics such as nausea, vomiting, and constipation, and potentially decrease the long-term risk of opioid dependence. As an additional benefit, a careful assessment of actual opioid will help to inform best practices for prescribing, as we may be overprescribing narcotic medications for this type of surgery. This study will evaluate a longer two-week course of gabapentin because it is currently standard of care to use gabapentin to treat neuropathic pain after SSLF; thus, gabapentin may help to address overall pain as well as neuropathic gluteal pain that can occur after SSLF. Furthermore, gabapentin is a relatively safe medication with the primary adverse events being dizziness and sedation.

Given the risk of overall postoperative pain and neuropathic gluteal pain after a sacrospinous ligament fixation for POP and the evidence that perioperative gabapentin may decrease acute pain and neuropathic pain, this study proposes a novel randomized trial to compare perioperative gabapentin versus placebo on postoperative pain after a vaginal SSLF surgery.

Conditions

Pelvic Organ Prolapse

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

Gabapentin

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.

Group Type: ACTIVE_COMPARATOR

Gabapentin

Intervention Type: DRUG

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

Placebo oral capsule

Participants will take placebo for the 2 weeks after surgery.

Group Type: PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type: DRUG

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

Interventions

Gabapentin

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

Intervention Type: DRUG

Placebo oral capsule

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

Intervention Type: DRUG

Other Intervention Names

neurontin; Placebo

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of North Carolina, Chapel Hill

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jennifer Wu, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

UNC Chapel Hill

Locations

UNC Chapel Hill

Chapel Hill, North Carolina, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 35084369 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

16-3392

Identifier Type: -

Identifier Source: org_study_id