Gabapentin for Postop Pain After SSLF

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT03123861
• Collaborator: (none)
• Enrollment: 45
• Location: 1
• Arms: 2
• Actual Duration (Months): 37.8
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Pelvic Organ Prolapse	Drug: Gabapentin; Drug: Placebo oral capsule	Phase 4

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 45 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Randomized Controlled Trial of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse
• Actual Study Start Date: Jun 1, 2017
• Actual Primary Completion Date: Jul 25, 2020
• Actual Study Completion Date: Jul 25, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Gabapentin; Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.; Other Names: neurontin
Placebo Comparator: Placebo oral capsule Participants will take placebo for the 2 weeks after surgery.	Drug: Placebo oral capsule; Patients randomized to this arm will receive 2 weeks of placebo post-operatively..; Other Names: Placebo

Outcome Measures

Primary Outcome Measures

1. Pain During Normal Activities (Surgical Pain Scale Item 2) [7 days after surgery]

   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.

Secondary Outcome Measures

1. Gluteal Pain During Normal Activities [7 days after surgery]

   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.

2. Worst Pain (Surgical Pain Scale Item 4) [7 days after surgery]

   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

3. Daily Narcotic Use [First 14 days after surgery]

   Median daily post-op narcotic pain medication in morphine milliequivalents per day during the first 14 days after surgery

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UNC Chapel Hill	Chapel Hill	North Carolina	United States	27599

Sponsors and Collaborators

• University of North Carolina, Chapel Hill

Investigators

• Principal Investigator: Jennifer Wu, MD, MPH, UNC Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 8, 2017

More Information

Publications

None provided.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT03123861
• Other Study ID Numbers: 16-3392
• First Posted: Apr 21, 2017
• Last Update Posted: Oct 26, 2020
• Last Verified: Sep 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Keywords provided by University of North Carolina, Chapel Hill: Pelvic Organ Prolapse; postoperative gluteal pain; opioid use
• Additional relevant MeSH terms: Prolapse; Pelvic Organ Prolapse; Gabapentin

Study Results

Participant Flow

Arm/Group Title	Gabapentin	Placebo Oral Capsule
Arm/Group Description	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. Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.	Participants will take placebo for the 2 weeks after surgery. Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Period Title: Overall Study
STARTED	22	23
Received Intervention	21	22
COMPLETED	19	20
NOT COMPLETED	3	3

Baseline Characteristics

Arm/Group Title	Gabapentin	Placebo Oral Capsule	Total
Arm/Group Description	Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days. Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.	Participants will take placebo for the 2 weeks after surgery. Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..	Total of all reporting groups
Overall Participants	22	23	45
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	65.3 (7.8)	61.2 (13.7)	62.8 (10.9)
Sex: Female, Male (Count of Participants)
Female	22 100%	23 100%	45 100%
Male	0 0%	0 0%	0 0%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	1 4.3%	1 2.2%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	2 9.1%	0 0%	2 4.4%
Black or African American	0 0%	2 8.7%	2 4.4%
White	20 90.9%	20 87%	40 88.9%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
United States	22 100%	23 100%	45 100%
Body Mass Index (kg / m^2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg / m^2]	29.1 (4.6)	28.1 (4.1)	28.6 (4.3)

Outcome Measures

1. Primary Outcome

Title	Pain During Normal Activities (Surgical Pain Scale Item 2)
Description	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.
Time Frame	7 days after surgery

Outcome Measure Data

Analysis Population Description

Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery

Arm/Group Title	Gabapentin	Placebo Oral Capsule
Arm/Group Description	Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days. Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.	Participants will take placebo for the 2 weeks after surgery. Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Measure Participants	19	20
Mean (Standard Deviation) [units on a scale]	1.6 (1.5)	3.2 (2.6)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo Oral Capsule
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	t-test, 2 sided
	Comments

2. Secondary Outcome

Title	Gluteal Pain During Normal Activities
Description	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.
Time Frame	7 days after surgery

Outcome Measure Data

Analysis Population Description

Participants who underwent a sacrospinous ligament fixation surgery with follow-up data 7 days after surgery

Arm/Group Title	Gabapentin	Placebo Oral Capsule
Arm/Group Description	Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days. Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.	Participants will take placebo for the 2 weeks after surgery. Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Measure Participants	19	20
Mean (Standard Deviation) [units on a scale]	2.1 (2.0)	3.4 (2.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo Oral Capsule
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.09
	Comments
	Method	t-test, 2 sided
	Comments

3. Secondary Outcome

Title	Worst Pain (Surgical Pain Scale Item 4)
Description	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
Time Frame	7 days after surgery

Outcome Measure Data

Analysis Population Description

Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery

Arm/Group Title	Gabapentin	Placebo Oral Capsule
Arm/Group Description	Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days. Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.	Participants will take placebo for the 2 weeks after surgery. Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Measure Participants	19	20
Mean (Standard Deviation) [units on a scale]	2.4 (2.4)	4.0 (2.7)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo Oral Capsule
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.08
	Comments
	Method	t-test, 2 sided
	Comments

4. Secondary Outcome

Title	Daily Narcotic Use
Description	Median daily post-op narcotic pain medication in morphine milliequivalents per day during the first 14 days after surgery
Time Frame	First 14 days after surgery

Outcome Measure Data

Analysis Population Description

Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery

Arm/Group Title	Gabapentin	Placebo Oral Capsule
Arm/Group Description	Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days. Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.	Participants will take placebo for the 2 weeks after surgery. Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Measure Participants	19	20
Median (Inter-Quartile Range) [morphine milliequivalents per day]	1.6	1.6

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Gabapentin, Placebo Oral Capsule
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.91
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	From the day of surgery until the 6-week postoperative visit
Arm/Group Title	Gabapentin		Placebo Oral Capsule
Arm/Group Description	Participants will take 300 mg Gabapentin for the first 3 days after surgery, then dose escalate to 300 mg BID for an additional 11 days. Gabapentin: Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.		Participants will take placebo for the 2 weeks after surgery. Placebo oral capsule: Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
All Cause Mortality
	Gabapentin		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Serious Adverse Events
	Gabapentin		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/21 (0%)		0/22 (0%)
Other (Not Including Serious) Adverse Events
	Gabapentin		Placebo Oral Capsule
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	2/21 (9.5%)		0/22 (0%)
Nervous system disorders
Dizziness	1/21 (4.8%)	1	0/22 (0%)	0
Drowsiness	1/21 (4.8%)	1	0/22 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.