Cesarean DeliveryPhase 4NCT03335436
Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient
A Phase 4 study testing Gabapentin in people with Cesarean Delivery and Pain Management, run by Vanderbilt University Medical Center.
Trial summary
The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cesarean delivery (CD). Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Cesarean Delivery, Pain Management
- 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
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2018to Dec 2020
- Phase
- Phase 4
- 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 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- singleton, term pregnancy
- currently on buprenorphine maintenance therapy
- scheduled for elective CD under spinal anesthesia
Who cannot join
- use illicit drugs or relapse during the last trimester of pregnancy
- positive drug screen at the time of delivery
- allergies to any medications used in the study
- taking prescribed gabapentin at the time of admission for CD
- contraindications to neuraxial anesthesia or require general anesthesia for CD
- designated ASA physical status 4 or above
About this study
Official title: A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient
The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cesarean delivery (CD).
Read the detailed description
Many strategies have been suggested to improve post-CD pain management in parturients on buprenorphine. While effective pain relief can be achieved, women maintained on buprenorphine during pregnancy have been shown to require up to 50% more opioids after CD compared to women with opioid use disorder not on a maintenance regimen. The perioperative use of gabapentin has been shown to reduce pain scores and opioid consumption following a variety of surgeries, ranging from cardiac bypass to total abdominal hysterectomy. The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective CD.
- Conditions
- Cesarean Delivery, Pain Management
- Being tested
- Gabapentin, Placebo
- Keywords
- buprenorphine maintenance
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GabapentinDrug
Participants will receive Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery
PlaceboDrug
Participants will receive Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery
| Study group | Role | What they receive |
|---|---|---|
| Gabapentin | Experimental | Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery Receives: Drug: Gabapentin |
| Placebo | Placebo comparator | Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid use 24 hours after cesarean delivery
Total opioid use tallied in morphine milligram equivalents at 24 hours after cesarean delivery
Measured: 24 hours after cesarean delivery
Total opioid use at time of hospital discharge after cesarean delivery
Total opioid use tallied in morphine milligram equivalents from the end cesarean delivery to the time of hospital discharge after cesarean delivery
Measured: From the end of cesarean delivery to the time of hospital discharge after cesarean delivery, approximately 4 days
Secondary outcomes (10)
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 4 hours post-partum
Pain assessment using VAS at rest 4 hours post-partum when 0 is no pain and 10 is worst pain
Measured: 4 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 4 hours post-partum
Pain assessment using VAS at movement 4 hours post-partum when 0 is no pain and 10 is worst pain
Measured: 4 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 24 hours post-partum
Pain assessment using VAS at rest 24 hours post-partum when 0 is no pain and 10 is worst pain
Measured: 24 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 24 hours post-partum
Pain assessment using VAS at movement 24 hours post-partum when 0 is no pain and 10 is worst pain
Measured: 24 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 48 hours post-partum
Pain assessment using VAS at rest 48 hours post-partum when 0 is no pain and 10 is worst pain
Measured: 48 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 48 hours post-partum
Pain assessment using VAS at movement 48 hours post-partum when 0 is no pain and 10 is worst pain
Measured: 48 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 30 days post-partum
Pain assessment using VAS at rest 30 days post-partum when 0 is no pain and 10 is worst pain
Measured: 30 days post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 30 days post-partum
Pain assessment using VAS at movement 30 days post-partum when 0 is no pain and 10 is worst pain
Measured: 30 days post-partum
Presence of persistent pain
Presence of persistent pain defined as pain score greater than baseline at 30 days post-partum
Measured: 30 days post-partum
Return to normal daily function
Return to normal daily function assessed with the Veterans RAND 12-item questionnaire
Measured: 30 days post-partum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2017
- Study start1 Apr 2018
- Primary completionNov 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: Lack of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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 4
- 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
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holly Ende, Vanderbilt University Medical Center
- Investigators
- Holly B Ende, M.D,, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03335436
- Sponsor's protocol ID
- 171688
- Status last verified
- Feb 2019
- First submitted
- 9 Oct 2017
- Last updated
- 18 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled Trial of Gabapentin in the Post-cesarean Pain Management of Buprenorphine Patient
- ClinicalTrials.gov ID
- NCT03335436
- Acronym / sponsor ID
- 171688
- Conditions
- Cesarean Delivery, Pain Management
- Keywords
- buprenorphine maintenance
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- Nov 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 7 Nov 2017 (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 determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective cesarean delivery (CD).
Detailed description
Many strategies have been suggested to improve post-CD pain management in parturients on buprenorphine. While effective pain relief can be achieved, women maintained on buprenorphine during pregnancy have been shown to require up to 50% more opioids after CD compared to women with opioid use disorder not on a maintenance regimen. The perioperative use of gabapentin has been shown to reduce pain scores and opioid consumption following a variety of surgeries, ranging from cardiac bypass to total abdominal hysterectomy. The purpose of this study is to determine whether a perioperative course of gabapentin in parturients on buprenorphine maintenance would improve analgesia after elective CD.
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 | Experimental | Drug: GabapentinGabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- singleton, term pregnancy
- currently on buprenorphine maintenance therapy
- scheduled for elective CD under spinal anesthesia
Key exclusion criteria (6 listed)
- use illicit drugs or relapse during the last trimester of pregnancy
- positive drug screen at the time of delivery
- allergies to any medications used in the study
- taking prescribed gabapentin at the time of admission for CD
- contraindications to neuraxial anesthesia or require general anesthesia for CD
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 |
|---|---|---|
| GabapentinParticipants will receive Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery | Drug | Gabapentin |
| PlaceboParticipants will receive Placebo with similar appearance to gabapentin by mouth one hour prior to scheduled cesarean delivery and by mouth every 8 hours post delivery | Drug | Placebo |
Primary outcome
Total opioid use 24 hours after cesarean delivery
Time frame: 24 hours after cesarean delivery
Total opioid use tallied in morphine milligram equivalents at 24 hours after cesarean delivery
Total opioid use at time of hospital discharge after cesarean delivery
Time frame: From the end of cesarean delivery to the time of hospital discharge after cesarean delivery, approximately 4 days
Total opioid use tallied in morphine milligram equivalents from the end cesarean delivery to the time of hospital discharge after cesarean delivery
10 secondary outcomes
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 4 hours post-partum
Time frame: 4 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 4 hours post-partum
Time frame: 4 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 24 hours post-partum
Time frame: 24 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 24 hours post-partum
Time frame: 24 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 48 hours post-partum
Time frame: 48 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 48 hours post-partum
Time frame: 48 hours post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 30 days post-partum
Time frame: 30 days post-partum
Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 30 days post-partum
Time frame: 30 days post-partum
Presence of persistent pain
Time frame: 30 days post-partum
Return to normal daily function
Time frame: 30 days post-partum
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 18 Feb 2019.
- Individual participant dataSharing planned: No
Related trials for Cesarean Delivery
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Ultrasound Assessment Of Gastric Volume In Pregnant Women Undergoing Elective Cesarean Section
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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.
Holly B Ende, M.D, principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gabapentin in people with Cesarean Delivery and Pain Management, run by Vanderbilt University Medical Center.
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 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 18 Feb 2019. 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 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?
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 opioid use 24 hours after cesarean delivery (time frame: 24 hours after cesarean delivery). The study lists 2 primary outcomes in all. 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 18 Feb 2019.