Gabapentin for Postop Pain After SSLF

Pelvic Organ Prolapse Clinical Trial

Official title:

Randomized Controlled Trial of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123861
• Other study ID #: 16-3392
• Status: Completed
• Phase: Phase 4
• Start date: June 1, 2017
• Est. completion date: July 25, 2020

Study information

• Verified date: September 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: July 25, 2020
• Est. primary completion date: July 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pelvic Organ Prolapse
• Prolapse

Intervention

Drug:
• Gabapentin
Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
• Placebo oral capsule
Patients randomized to this arm will receive 2 weeks of placebo post-operatively..

Locations

Country	Name	City	State
United States	UNC Chapel Hill	Chapel Hill	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Gluteal Pain During Normal Activities	Gluteal post-op pain will be measured by an item similar to that used for the primary outcome which asks for the average amount of gluteal 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	Worst Pain (Surgical Pain Scale Item 4)	Post-operative pain will be measured by item 4 of the surgical pain scale (SPS). This item asks for how unpleasant or disturbing the worst pain was in the last 24 hours on a scale of 1-10 with 10 representing the most intense/worst pain	7 days after surgery
Secondary	Daily Narcotic Use	Median daily post-op narcotic pain medication in morphine milliequivalents per day during the first 14 days after surgery	First 14 days after surgery