Postoperative PainPhase 1/2GRIPPNCT03750773
Gabapentin for Relief of Immediate Postoperative Pain
A Phase 1/2 study testing Gabapentin 600mg in people with Postoperative Pain, run by Indiana University.
Trial summary
The purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Gabapentin 600mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 2 Jul 2019to Apr 2020
- Phase
- Phase 1/2
- 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
- Pregnant women at least 18 years of age
- Gestational age > or = to 30 weeks
- Singleton gestation
- Women undergoing a non-emergent cesarean delivery
- Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
- Ability to undergo the informed consent process in English
Who cannot join
- Vertical skin incision
- General anesthesia for cesarean
- History of major depression or postpartum depression requiring medication
- Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not include opioids given for labor anesthesia.
- Magnesium sulfate treatment postpartum
- Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder
About this study
Official title: GRIPP: Gabapentin for Relief of Immediate Postoperative Pain
The purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery.
Read the detailed description
This is a randomized, placebo controlled, double blind study. After consent, the subject will complete a Depression Screening to establish a baseline score. Within 2 hours following completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin) or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have the option to take routine opioid pain medication if her pain is uncontrolled. She will be asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For breastfeeding infants, data will be collected regarding overall feeding quality, somnolence levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin level while inpatient and any treatment for this as applicable. The subject will complete the Depression Scale again at 48 hours following delivery. At one week postpartum, they will receive a phone call and the following will be addressed: a final pain survey, a Depression survey, nausea level, number of pain pills left in their prescription, adverse events, whether or not they would take the study drug again if they should happen to have another cesarean section, and infant well-being if breastfeeding.
- Conditions
- Postoperative Pain
- Being tested
- Gabapentin 600mg, Placebo oral capsule
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gabapentin 600mgDrug
Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.
Placebo oral capsuleDrug
Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.
| Study group | Role | What they receive |
|---|---|---|
| Subjects receiving gabapentin drug | Active comparator | Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean Receives: Drug: Gabapentin 600mg |
| Subjects receiving placebo oral capsule | Placebo comparator | Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean Receives: Drug: Placebo oral capsule |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine milligram equivalents consumed in the first 48 hours postoperatively
The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.
Measured: 48 hours
Secondary outcomes (3)
Total morphine milligram equivalents from hospital discharge to one week postoperatively
The total number of pills of postoperative opioid pain medication consumed will be recorded, converted into morphine milligram equivalents, and compared between the two arms.
Measured: one week
Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively
Each subject will report a measure of pain on a Visual Analog Scale before and 2-4 hours after each dose of study drug or placebo, and at 24, 36, and 48 hours postoperatively.
Measured: 48 hours
Number and type of adverse events potentially associated with study drug (Safety and Tolerability)
Adverse events of maternal dizziness, nausea, notable peripheral edema, suicidal behavior or ideation, infant somnolence, and drug reactions will be recorded
Measured: one week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2018
- Study start2 Jul 2019 (estimated)
- Primary completionMar 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, David Haas, Indiana University
- Investigators
- David M Haas, MD, MS, Principal investigator, IUSM, Dept OBGYN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03750773
- Sponsor's protocol ID
- 1809661339
- Acronym
- GRIPP
- Status last verified
- Jul 2020
- First submitted
- 16 Nov 2018
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- GRIPP: Gabapentin for Relief of Immediate Postoperative Pain
- ClinicalTrials.gov ID
- NCT03750773
- Acronym / sponsor ID
- GRIPP / 1809661339
- Conditions
- Postoperative Pain
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 2 Jul 2019 (estimated)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 23 Nov 2018 (actual)
- 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.
The purpose of this study is to use gabapentin as an additional or alternative treatment for short term pain control following cesarean delivery in order to reduce the use of opioid pain medication and improve overall pain control following surgery.
Detailed description
This is a randomized, placebo controlled, double blind study. After consent, the subject will complete a Depression Screening to establish a baseline score. Within 2 hours following completion of a cesarean section, the subject will be given the study drug (600mg Gabapentin) or placebo. She will be given this every 8 hours for 48 hours scheduled. She will also have the option to take routine opioid pain medication if her pain is uncontrolled. She will be asked to rate her postoperative pain on a Visual Analog Scale prior to receiving the study drug, 2-4 hours after each dose, and at 24, 36, and 48 hours postoperatively. For breastfeeding infants, data will be collected regarding overall feeding quality, somnolence levels, gestational age at birth, infant weight at birth and discharge, the highest bilirubin level while inpatient and any treatment for this as applicable. The subject will complete the Depression Scale again at 48 hours following delivery. At one week postpartum, they will receive a phone call and the following will be addressed: a final pain survey, a Depression survey, nausea level, number of pain pills left in their prescription, adverse events, whether or not they would take the study drug again if they should happen to have another cesarean section, and infant well-being if breastfeeding.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects receiving gabapentin drug | Active comparator | Drug: Gabapentin 600mgAdministration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean |
| Subjects receiving placebo oral capsule | Placebo comparator | Drug: Placebo oral capsuleAdministration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Pregnant women at least 18 years of age
- Gestational age > or = to 30 weeks
- Singleton gestation
- Women undergoing a non-emergent cesarean delivery
- Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
Key exclusion criteria (6 listed)
- Vertical skin incision
- General anesthesia for cesarean
- History of major depression or postpartum depression requiring medication
- Chronic opiate use during pregnancy, defined as anyone who has taken an opioid or opioid replacement therapy in the 3 days prior to admission for delivery. This does not include opioids given for labor anesthesia.
- Magnesium sulfate treatment postpartum
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 |
|---|---|---|
| Gabapentin 600mgSubject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control. | Drug | Subjects receiving gabapentin drug |
| Placebo oral capsuleSubject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control. | Drug | Subjects receiving placebo oral capsule |
Primary outcome
Total morphine milligram equivalents consumed in the first 48 hours postoperatively
Time frame: 48 hours
The total morphine milligram equivalents consumed by the subjects within the first 48 hours postoperatively will be recorded and compared between the two arms.
3 secondary outcomes
Total morphine milligram equivalents from hospital discharge to one week postoperatively
Time frame: one week
Subject reported pain rating on a Visual Analog Scale within the first 48 hours postoperatively
Time frame: 48 hours
Number and type of adverse events potentially associated with study drug (Safety and Tolerability)
Time frame: one week
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
- 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.
David M Haas, MD, MS principal investigator
IUSM, Dept OBGYN
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Gabapentin 600mg in people with Postoperative Pain, run by Indiana University.
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 6 inclusion and 6 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: withdrawn, as of the sponsor's last update on 29 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Total morphine milligram equivalents consumed in the first 48 hours postoperatively (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jul 2020; AzTrials last refreshed its copy on 7 Nov 2026.