Gabapentin for Postop Pain After SSLF
| Status: | Recruiting |
|---|---|
| Conditions: | Women's Studies |
| Therapuetic Areas: | Reproductive |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 6/16/2018 |
| Start Date: | June 1, 2017 |
| End Date: | December 2019 |
| Contact: | Jennifer Wu, MD, MPH |
| Email: | jennifer_wu@med.unc.edu |
| Phone: | 919-966-4717 |
RCT of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse
Purpose: To assess the impact of gabapentin versus placebo on overall postoperative pain and
gluteal pain at 1 week post 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.
gluteal pain at 1 week post 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.
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 SSLF 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.
The aim of this study is 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 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 it is possible that we are
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.
An exploratory component of this study will be a pharmacogenetics aim for narcotic use. It is
known that genetic variability in drug metabolizing enzymes may impact the response to
opioids. For example, poor metabolizers may not convert opioids to their active forms
resulting in less pain relief and potentially higher doses of medications. Conversely those
who are fast metabolizers may have higher levels of active forms and thus require lower doses
of narcotics. One well-characterized cytochrome P450 (CYP) enzyme is CYP2D6, which
metabolizes commonly used opioids such as codeine, tramadol, hydrocodone and oxycodone. The
CYP2D6 gene has several genetic variants, which result in different metabolizer statuses
ranging from poor metabolizers (PM), intermediate metabolizers (IM), extensive metabolizers
(EM), to ultrarapid metabolizers (UM). These different CYP2D6 profiles may be clinically
important for opioid use, as they may contribute to the variability in efficacy and adverse
events to these drugs. Because this study will provide detailed information about narcotic
use, this will be an ideal study for this exploratory pharmacogenetics analysis.
Given the risk of overall postoperative pain and neuropathic gluteal pain after a SSLF 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.
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 SSLF 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.
The aim of this study is 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 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 it is possible that we are
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.
An exploratory component of this study will be a pharmacogenetics aim for narcotic use. It is
known that genetic variability in drug metabolizing enzymes may impact the response to
opioids. For example, poor metabolizers may not convert opioids to their active forms
resulting in less pain relief and potentially higher doses of medications. Conversely those
who are fast metabolizers may have higher levels of active forms and thus require lower doses
of narcotics. One well-characterized cytochrome P450 (CYP) enzyme is CYP2D6, which
metabolizes commonly used opioids such as codeine, tramadol, hydrocodone and oxycodone. The
CYP2D6 gene has several genetic variants, which result in different metabolizer statuses
ranging from poor metabolizers (PM), intermediate metabolizers (IM), extensive metabolizers
(EM), to ultrarapid metabolizers (UM). These different CYP2D6 profiles may be clinically
important for opioid use, as they may contribute to the variability in efficacy and adverse
events to these drugs. Because this study will provide detailed information about narcotic
use, this will be an ideal study for this exploratory pharmacogenetics analysis.
Given the risk of overall postoperative pain and neuropathic gluteal pain after a SSLF 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.
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 POP (midurethral sling is not an exclusion)
- Planning a concurrent TVH, 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
We found this trial at
1
site
CHapel Hill, North Carolina 27599
Principal Investigator: Jennifer M Wu, MD
Phone: 919-966-4717
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