Pelvic Organ ProlapsePhase 4NCT03123861
Gabapentin for Postop Pain After SSLF
A Phase 4 study testing Gabapentin in people with Pelvic Organ Prolapse, run by University of North Carolina, Chapel Hill at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse
- What is being tested?
- Gabapentin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 25 Jul 2020
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women age 18+
- English-speaking
- Planning to undergo a vaginal SSLF
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial 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 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.
Read the 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
- Being tested
- Gabapentin, Placebo oral capsule
- Keywords
- Pelvic Organ Prolapse, postoperative gluteal pain, opioid use
- Medical subject headings
- Pelvic Organ Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Also called neurontin
Patients randomized to this arm will receive 2 weeks of gabapentin post-operatively.
Placebo oral capsuleDrug
Also called Placebo
Patients randomized to this arm will receive 2 weeks of placebo post-operatively..
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Active comparator | 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. Receives: Drug: Gabapentin |
| Placebo oral capsule | Placebo comparator | Participants will take placebo for the 2 weeks after surgery. Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 7 days after surgery
Secondary outcomes (3)
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.
Measured: 7 days after surgery
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
Measured: 7 days after surgery
Daily Narcotic Use
Median daily post-op narcotic pain medication in morphine milliequivalents per day during the first 14 days after surgery
Measured: First 14 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2017
- Study start1 Jun 2017
- Primary completion25 Jul 2020
- Study completion25 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ ProlapseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jennifer Wu, MD, MPH, Principal investigator, UNC Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03123861
- Sponsor's protocol ID
- 16-3392
- Status last verified
- Sep 2020
- First submitted
- 26 Mar 2017
- Last updated
- 26 Oct 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35084369
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Gabapentin Versus Placebo for Postoperative Pain After Sacrospinous Ligament Fixation for Pelvic Organ Prolapse
- ClinicalTrials.gov ID
- NCT03123861
- Acronym / sponsor ID
- 16-3392
- Conditions
- Pelvic Organ Prolapse
- Keywords
- Pelvic Organ Prolapse, postoperative gluteal pain, opioid use
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 25 Jul 2020 (actual)
- Study completion
- 25 Jul 2020 (actual)
- First posted
- 21 Apr 2017 (actual)
- Results
- Posted 26 Oct 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Gabapentin | Active comparator | Drug: GabapentinParticipants 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. |
| Placebo oral capsule | Placebo comparator | Drug: Placebo oral capsuleParticipants will take placebo for the 2 weeks after surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women age 18+
- English-speaking
- Planning to undergo a vaginal SSLF
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GabapentinAlso: neurontinPatients randomized to this arm will receive 2 weeks of gabapentin post-operatively. | Drug | Gabapentin |
| Placebo oral capsuleAlso: PlaceboPatients randomized to this arm will receive 2 weeks of placebo post-operatively.. | Drug | Placebo oral capsule |
Primary outcome
Pain During Normal Activities (Surgical Pain Scale Item 2)
Time frame: 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.
3 secondary outcomes
Gluteal Pain During Normal Activities
Time frame: 7 days after surgery
Worst Pain (Surgical Pain Scale Item 4)
Time frame: 7 days after surgery
Daily Narcotic Use
Time frame: First 14 days after surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35084369Wu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Wu, MD, MPH principal investigator
UNC Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Pelvic Organ Prolapse, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain During Normal Activities (Surgical Pain Scale Item 2) (time frame: 7 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03123861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2020.