Drug UsagePhase 1NCT02490345
Gabapentin as Adjunctive Treatment for Postoperative Pain Control
A Phase 1 study testing gabapentin in people with Drug Usage, run by Indiana University at 2 sites in United States.
Trial summary
The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Drug Usage
- 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
- 13 participants
- Where
- 2 sitesUnited States
- Study dates
- Oct 2015to 29 Jun 2017
- Phase
- Phase 1
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Pregnant women at least 18 years of age
- Singleton gestation
- Gestational age equal to or greater than 30 weeks
- Women undergoing a non-emergent (often scheduled) repeat cesarean delivery
- Spinal anesthesia utilized during cesarean
Who cannot join
- History of opiate abuse
- Women on opiates during pregnancy
- Women requiring treatment with magnesium sulfate postpartum
- Preexisting Fibromyalgia, chronic pain syndrome, or rheumatologic disorder
- General anesthesia required for cesarean
- Plans to breastfeed
- History of major depression or postpartum depression requiring medication
- Planned classical cesarean section
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Eskenazi Health
Indianapolis, Indiana, 46202
Eskenazi Hospital
Indianapolis, Indiana, 46202
About this study
Official title: Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section
The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control.
Read the detailed description
After consent has been obtained for the study and the cesarean has been completed, when the participant is in the recovery room, she will take the first pill of the study drug. This will occur approximately 30-60 minutes after the cesarean is completed. The time of first dose will be noted on the data capture form. The following will then occur:
- Participants will take study capsules (either 600 mg gabapentin or placebo) every 8 hours for the first 48 hours after beginning the study. The nurse on the unit will be sent the study drug in a blinded capsule by the Investigational Pharmacy.
- Participants will be asked about postoperative pain on a Visual Analog Scale by the care nurses or study personnel before each dose of study drug, before receiving any opioid medication, 2-4 hours after study drugs are consumed, at 24, 36 and 48 hours post surgery, and any other times during routine postoperative clinical care would warrant. Women record pain postoperatively on a similar scale as part of routine clinical care. Prescription pain medication will be given per clinical routine care. Study personnel will note how many pills were sent home.
- One week (6-9 days) after the cesarean delivery, participants will be contacted by phone or other preferred method and asked about pain score, somnolence scores, dizziness, nausea, depression, any problems they are experiencing, and asked how many pain pills are left in their prescriptions given when they went home. These data will be recorded.
An Edinburgh Depression Scale will also be administered upon consent, at 48 hours, and again at one week after delivery. If the scores meet the specified criteria, the provider will by notified or if the subject has already been discharged from the hospital, she will be given contact information for follow up care.
- Conditions
- Drug Usage
- Being tested
- gabapentin, Placebo
- Keywords
- gabapentin
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gabapentinDrug
gabapentin usage as adjunctive treatment for pain control
PlaceboDrug
Identical placebo
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin Administration | Active comparator | gabapentin 600mg orally every 8 hours x 48 hours Receives: Drug: gabapentin |
| Placebo | Placebo comparator | Placebo , 1 tablet, orally every 8 hours x 48 hours Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amount of opioid equivalents consumed
Measured: 48 hours after cesarean delivery
Secondary outcomes (3)
Amount of opioid equivalents consumed
Measured: one week after cesarean delivery
VAS pain scores
Measured: one week after cesarean delivery
Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions
Measured: one week after cesarean delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2015 (estimated)
- Study startOct 2015
- Primary completion29 Jun 2017
- Study completion29 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug UsageStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 13 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 Haas, MD, MS, Principal investigator, Indiana School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02490345
- Sponsor's protocol ID
- 1507497375
- Status last verified
- Aug 2017
- First submitted
- 1 Jul 2015
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Gabapentin on Postoperative Pain Control After a Cesarean Section
- ClinicalTrials.gov ID
- NCT02490345
- Acronym / sponsor ID
- 1507497375
- Conditions
- Drug Usage
- Keywords
- gabapentin
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- 29 Jun 2017 (actual)
- Study completion
- 29 Jun 2017 (actual)
- First posted
- 3 Jul 2015 (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.
The specific aims of this research study are to use 600 mg gabapentin as an adjunctive treatment for acute postoperative pain control in order to reduce postoperative opiate consumption and improve postoperative pain control.
Detailed description
After consent has been obtained for the study and the cesarean has been completed, when the participant is in the recovery room, she will take the first pill of the study drug. This will occur approximately 30-60 minutes after the cesarean is completed. The time of first dose will be noted on the data capture form. The following will then occur:
- Participants will take study capsules (either 600 mg gabapentin or placebo) every 8 hours for the first 48 hours after beginning the study. The nurse on the unit will be sent the study drug in a blinded capsule by the Investigational Pharmacy.
- Participants will be asked about postoperative pain on a Visual Analog Scale by the care nurses or study personnel before each dose of study drug, before receiving any opioid medication, 2-4 hours after study drugs are consumed, at 24, 36 and 48 hours post surgery, and any other times during routine postoperative clinical care would warrant. Women record pain postoperatively on a similar scale as part of routine clinical care. Prescription pain medication will be given per clinical routine care. Study personnel will note how many pills were sent home.
- One week (6-9 days) after the cesarean delivery, participants will be contacted by phone or other preferred method and asked about pain score, somnolence scores, dizziness, nausea, depression, any problems they are experiencing, and asked how many pain pills are left in their prescriptions given when they went home. These data will be recorded.
An Edinburgh Depression Scale will also be administered upon consent, at 48 hours, and again at one week after delivery. If the scores meet the specified criteria, the provider will by notified or if the subject has already been discharged from the hospital, she will be given contact information for follow up care.
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 |
|---|---|---|
| Gabapentin Administration | Active comparator | Drug: gabapentingabapentin 600mg orally every 8 hours x 48 hours |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo , 1 tablet, orally every 8 hours x 48 hours |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Pregnant women at least 18 years of age
- Singleton gestation
- Gestational age equal to or greater than 30 weeks
- Women undergoing a non-emergent (often scheduled) repeat cesarean delivery
- Spinal anesthesia utilized during cesarean
Key exclusion criteria (8 listed)
- History of opiate abuse
- Women on opiates during pregnancy
- Women requiring treatment with magnesium sulfate postpartum
- Preexisting Fibromyalgia, chronic pain syndrome, or rheumatologic disorder
- General anesthesia required for cesarean
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 usage as adjunctive treatment for pain control | Drug | Gabapentin Administration |
| PlaceboIdentical placebo | Drug | Placebo |
Primary outcome
Amount of opioid equivalents consumed
Time frame: 48 hours after cesarean delivery
3 secondary outcomes
Amount of opioid equivalents consumed
Time frame: one week after cesarean delivery
VAS pain scores
Time frame: one week after cesarean delivery
Adverse events (somnolence, dizziness, nausea, depression, suicidal ideation, or notable peripheral edema) or drug reactions
Time frame: one week after cesarean delivery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Individual participant dataSharing planned: Undecided
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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 Haas, MD, MS principal investigator
Indiana School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing gabapentin in people with Drug Usage, run by Indiana University at 2 sites 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 5 inclusion and 8 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 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 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.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Amount of opioid equivalents consumed (time frame: 48 hours after cesarean delivery). 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 23 Aug 2017.