Pelvic Organ ProlapsePhase 3GROUPNCT02999724
Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study")
A Phase 3 study testing Gabapentin in people with Pelvic Organ Prolapse, run by Mount Sinai Hospital, Canada at 1 site in Canada.
Trial summary
Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Jan 2018
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 years and older
- uterovaginal prolapse with or without stress urinary incontinence
- booked for vaginal hysterectomy, anterior and/or posterior vaginal repair, with or without TVT
Who cannot join
- Women already on gabapentin for other indications
- Women with proven allergy or sensitivity to gabapentin
- Women with a contraindication to gabapentin
- Women unable to understand spoken English
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Department of Obstetrics and Gynecology, Mount Sinai Hospital
Toronto, Ontario, M5G1Z5
Danny Lovatsis, MD MSc, 4165864566, dlovatsis@mtsinai.on.ca
Adrienne Li, MD, 416-586-4566, adrienne.lk.li@gmail.com
About this study
Official title: Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study"): A Randomized Control Trial in Women Undergoing Reconstructive Pelvic Surgery
Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed. Opioids are the first choice for pain medication administered after surgery, but carry significant side effects. Several studies have demonstrated that if patients are given gabapentin before surgery, they require less opioids after surgery. However, there have not been any studies examining gabapentin's effects on post-operative pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence. Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore patients experience a "bulge" or "pressure" in the vagina. Patients with these conditions are typically offered medical treatments, but some may require surgery, and this usually consists of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to patients undergoing urogynecologic surgery on their pain levels after surgery, including the amount of opioid pain medication required. We hypothesize that the patients who receive gabapentin before surgery will require significantly less opioids.
Over a six-month period, patients seen in Urogynecology clinics will be invited to participate in the study. Women who are already on gabapentin for other reasons, have an allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand spoken English will be excluded from the study. After providing informed consent, they will be randomized to either receive gabapentin or a placebo pill. They will receive the standard surgical care, including the usual anesthesia for surgery and routine pain medications available after surgery. We will then compare the differences in opioid consumption in the first 24 hours after surgery as well as the time from the end of surgery to leaving to the recovery room and the length of recovery room stay between the gabapentin and placebo groups. We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the patients in each group.
Read the detailed description
This study will be a randomized double blinded placebo controlled trial. All women presenting to Mount Sinai Hospital eligible for surgery with pelvic organ prolapse symptoms requiring hysterectomy with other pelvic reconstruction (repair of cystocele and/or rectocele, with or without TVT) will be provided with a written informed consent to be randomized to either receiving pre-operative gabapentin single dose or placebo 2 hours prior to surgery. The single dose of gabapentin will be 600 mg for patients under 65 years old and 300 mg for those 65 years old and above. All patients will have pre-operative assessment according to the usual routine that will include urogynecological history taking, physical examination, urodynamic testing and blood work. Urodynamic testing will include measurement of the post-void residual by urethral catheterization or bladder scan, uroflowmetry, a filling cystometrogram and urethral pressure profilometry. Medication and placebo will be prepared by the hospital pharmacy to look alike to blind staff and patients. Medication or placebo will be given with other pre-anesthesia medications such as celecoxib and acetaminophen according to usual protocol. Routine peri-operative surgical/anesthesia management will be unchanged from the usual care. Post-operative pain score will be measured using a visual analogue scale (VAS) from 1 to 10. Total Opioids use during the first 24 hours after surgery will be calculated from patients' paper and electronic chart, and conversion will be made to morphine equivalents.
- Conditions
- Pelvic Organ Prolapse
- Being tested
- Gabapentin, placebo
- 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
Gabapentin 300-600 mg 1 hour preop
placeboOther
Also called placebo capsule
placebo capsule(s) 1 hour preop
| Study group | Role | What they receive |
|---|---|---|
| gabapentin | Experimental | gabapentin 300-600 mg 1 hour preop Receives: Drug: Gabapentin |
| placebo | Placebo comparator | placebo capsule(s) 1 hour preop Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
opioid consumption postop
total opioid use 24 hours after surgery
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2016 (estimated)
- Study startJan 2017
- Primary completionSep 2017 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mount Sinai Hospital, Canada
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Danny Lovatsis, Mount Sinai Hospital, Canada
- Investigators
- Danny Lovatsis, MD, Principal investigator, Sinai Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02999724
- Sponsor's protocol ID
- 16-0262-A
- Acronym
- GROUP
- Status last verified
- Feb 2017
- First submitted
- 17 Dec 2016
- Last updated
- 14 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Li ALK, Wadsworth K, Siddiqui NT, Alarab M, McDermott CD, Lemos N, Dawood A, Lovatsis D. Does low-dose gapapentin reduce opioid use postoperatively?: A randomized controlled trial in women undergoing reconstructive pelvic surgery. Int Urogynecol J. 2019 Feb;30(2):211-217. doi: 10.1007/s00192-018-3617-3. Epub 2018 Mar 21.
PubMed 29564507
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gabapentin Reduces Opioid Use Postoperatively ("GROUP Study"): A Randomized Control Trial in Women Undergoing Reconstructive Pelvic Surgery
- ClinicalTrials.gov ID
- NCT02999724
- Acronym / sponsor ID
- GROUP / 16-0262-A
- Conditions
- Pelvic Organ Prolapse
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Mount Sinai Hospital, CanadaUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Sep 2017 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 21 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gabapentin is a medication used primarily to treat seizures and pain. Studies have shown that this medication can help reduce pain after surgery, including hysterectomy, where the uterus or "womb" is removed. Opioids are the first choice for pain medication administered after surgery, but carry significant side effects. Several studies have demonstrated that if patients are given gabapentin before surgery, they require less opioids after surgery. However, there have not been any studies examining gabapentin's effects on post-operative pain in urogynecologic surgery, which treats pelvic organ prolapse and urinary incontinence. Pelvic organ prolapse occurs when female pelvic floor supports have weakened and therefore patients experience a "bulge" or "pressure" in the vagina. Patients with these conditions are typically offered medical treatments, but some may require surgery, and this usually consists of vaginal hysterectomy, pelvic floor repair, and a mid-urethral sling to treat any concurrent urinary incontinence. Our study aims to look at the effect of gabapentin given to patients undergoing urogynecologic surgery on their pain levels after surgery, including the amount of opioid pain medication required. We hypothesize that the patients who receive gabapentin before surgery will require significantly less opioids.
Over a six-month period, patients seen in Urogynecology clinics will be invited to participate in the study. Women who are already on gabapentin for other reasons, have an allergy to gabapentin, have a reason they cannot take gabapentin, or who cannot understand spoken English will be excluded from the study. After providing informed consent, they will be randomized to either receive gabapentin or a placebo pill. They will receive the standard surgical care, including the usual anesthesia for surgery and routine pain medications available after surgery. We will then compare the differences in opioid consumption in the first 24 hours after surgery as well as the time from the end of surgery to leaving to the recovery room and the length of recovery room stay between the gabapentin and placebo groups. We will also analyze the differences in anxiety, drowsiness, pain, and nausea as rated by the patients in each group.
Detailed description
This study will be a randomized double blinded placebo controlled trial. All women presenting to Mount Sinai Hospital eligible for surgery with pelvic organ prolapse symptoms requiring hysterectomy with other pelvic reconstruction (repair of cystocele and/or rectocele, with or without TVT) will be provided with a written informed consent to be randomized to either receiving pre-operative gabapentin single dose or placebo 2 hours prior to surgery. The single dose of gabapentin will be 600 mg for patients under 65 years old and 300 mg for those 65 years old and above. All patients will have pre-operative assessment according to the usual routine that will include urogynecological history taking, physical examination, urodynamic testing and blood work. Urodynamic testing will include measurement of the post-void residual by urethral catheterization or bladder scan, uroflowmetry, a filling cystometrogram and urethral pressure profilometry. Medication and placebo will be prepared by the hospital pharmacy to look alike to blind staff and patients. Medication or placebo will be given with other pre-anesthesia medications such as celecoxib and acetaminophen according to usual protocol. Routine peri-operative surgical/anesthesia management will be unchanged from the usual care. Post-operative pain score will be measured using a visual analogue scale (VAS) from 1 to 10. Total Opioids use during the first 24 hours after surgery will be calculated from patients' paper and electronic chart, and conversion will be made to morphine equivalents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| gabapentin | Experimental | Drug: Gabapentingabapentin 300-600 mg 1 hour preop |
| placebo | Placebo comparator | Other: placeboplacebo capsule(s) 1 hour preop |
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 years and older
- uterovaginal prolapse with or without stress urinary incontinence
- booked for vaginal hysterectomy, anterior and/or posterior vaginal repair, with or without TVT
Key exclusion criteria (4 listed)
- Women already on gabapentin for other indications
- Women with proven allergy or sensitivity to gabapentin
- Women with a contraindication to gabapentin
- Women unable to understand spoken English
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 |
|---|---|---|
| GabapentinGabapentin 300-600 mg 1 hour preop | Drug | gabapentin |
| placeboAlso: placebo capsuleplacebo capsule(s) 1 hour preop | Other | placebo |
Primary outcome
opioid consumption postop
Time frame: 24 hours
total opioid use 24 hours after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2017.
- Derived from this study: PubMed 29564507Li ALK, Wadsworth K, Siddiqui NT, Alarab M, McDermott CD, Lemos N, Dawood A, Lovatsis D. Does low-dose gapapentin reduce opioid use postoperatively?: A randomized controlled trial in women undergoing reconstructive pelvic surgery. Int Urogynecol J. 2019 Feb;30(2):211-217. doi: 10.1007/s00192-018-3617-3. Epub 2018 Mar 21.
- Individual participant dataSharing planned: No
Related trials for Pelvic Organ Prolapse
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Pelvic Floor Muscle Training During Pregnancy
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Perineal Protection Device for Reducing Perineal Trauma During Vaginal Delivery in First-time Mothers: a Multicenter Randomized Controlled Trial
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Suzetrigine Following Urogynecologic Surgery: Investigation of Postoperative Pain Management
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Clinical Outcomes of Rectopexy for Rectal Prolapse
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Patient-Centered Outcomes in the Surgical Treatment of Uterovaginal Prolapse
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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.
Danny Lovatsis, MD principal investigator
Sinai Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Gabapentin in people with Pelvic Organ Prolapse, run by Mount Sinai Hospital, Canada at 1 site in Canada.
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 4 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: status not confirmed, as of the sponsor's last update on 14 Feb 2017. 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 Canada. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danny Lovatsis, MD (416-586-4566, danny.lovatsis@sinaihealthsystem.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
opioid consumption postop (time frame: 24 hours). 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 NCT02999724, 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 14 Feb 2017.