Pelvic Organ Prolapse
Conditions
Keywords
Pelvic Organ Prolapse, postoperative gluteal pain, opioid use
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.
Interventions
DRUGGabapentin
Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
DRUGPlacebo oral capsule
Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
Sponsors
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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 |
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Gabapentin 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. | 22 |
| Placebo Oral Capsule 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.. | 23 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Protocol Violation | 1 | 1 |
| Overall Study | Withdrawal by Subject | 2 | 2 |
Baseline characteristics
| Characteristic | Gabapentin | Placebo Oral Capsule | Total |
|---|---|---|---|
| Age, Continuous | 65.3 years STANDARD_DEVIATION 7.8 | 61.2 years STANDARD_DEVIATION 13.7 | 62.8 years STANDARD_DEVIATION 10.9 |
| Body Mass Index | 29.1 kg / m^2 STANDARD_DEVIATION 4.6 | 28.1 kg / m^2 STANDARD_DEVIATION 4.1 | 28.6 kg / m^2 STANDARD_DEVIATION 4.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 20 Participants | 20 Participants | 40 Participants |
| Region of Enrollment United States | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Female | 22 Participants | 23 Participants | 45 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 21 | 0 / 22 |
| other Total, other adverse events | 2 / 21 | 0 / 22 |
| serious Total, serious adverse events | 0 / 21 | 0 / 22 |
Outcome results
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.
Time frame: 7 days after surgery
Population: Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Pain During Normal Activities (Surgical Pain Scale Item 2) | 1.6 units on a scale | Standard Deviation 1.5 |
| Placebo Oral Capsule | Pain During Normal Activities (Surgical Pain Scale Item 2) | 3.2 units on a scale | Standard Deviation 2.6 |
p-value: 0.09t-test, 2 sided
Secondary
Daily Narcotic Use
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
Population: Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Gabapentin | Daily Narcotic Use | 1.6 morphine milliequivalents per day |
| Placebo Oral Capsule | Daily Narcotic Use | 1.6 morphine milliequivalents per day |
p-value: 0.91Wilcoxon (Mann-Whitney)
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.
Time frame: 7 days after surgery
Population: Participants who underwent a sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Gluteal Pain During Normal Activities | 2.1 units on a scale | Standard Deviation 2 |
| Placebo Oral Capsule | Gluteal Pain During Normal Activities | 3.4 units on a scale | Standard Deviation 2.4 |
p-value: 0.09t-test, 2 sided
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
Time frame: 7 days after surgery
Population: Participants who underwent sacrospinous ligament fixation surgery with follow-up data 7 days after surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Gabapentin | Worst Pain (Surgical Pain Scale Item 4) | 2.4 units on a scale | Standard Deviation 2.4 |
| Placebo Oral Capsule | Worst Pain (Surgical Pain Scale Item 4) | 4.0 units on a scale | Standard Deviation 2.7 |
p-value: 0.08t-test, 2 sided