NCT03335436

Brief 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).

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2018

Typical duration for phase_4

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 9, 2017

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 7, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

April 1, 2018

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

February 18, 2019

Status Verified

February 1, 2019

Enrollment Period

2.6 years

First QC Date

October 9, 2017

Last Update Submit

February 14, 2019

Conditions

Cesarean DeliveryPain Management

Keywords

buprenorphine maintenance

Outcome Measures

Primary Outcomes (2)

  • Total opioid use 24 hours after cesarean delivery

    Total opioid use tallied in morphine milligram equivalents at 24 hours after cesarean delivery

    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

    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

    4 hours post-partum

  • Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 4 hours post-partum

    4 hours post-partum

  • Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 24 hours post-partum

    24 hours post-partum

  • Pain assessment using 11-point Visual/Verbal Analog (VAS) at movement 24 hours post-partum

    24 hours post-partum

  • Pain assessment using 11-point Visual/Verbal Analog (VAS) at rest 48 hours post-partum

    48 hours post-partum

  • +5 more secondary outcomes

Study Arms (2)

Gabapentin

EXPERIMENTAL

Gabapentin 600 mg by mouth one hour prior to scheduled cesarean delivery and 400 mg by mouth every 8 hours post delivery

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

Drug: Placebo

Interventions

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

Gabapentin
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

Placebo

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • singleton, term pregnancy
  • currently on buprenorphine maintenance therapy
  • scheduled for elective CD under spinal anesthesia

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Agnosia

Interventions

Gabapentin

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AminesOrganic Chemicalsgamma-Aminobutyric AcidAminobutyratesButyratesAcids, AcyclicCarboxylic AcidsCyclohexanecarboxylic AcidsAcids, CarbocyclicCyclohexanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsAmino AcidsAmino Acids, Peptides, and Proteins

Study Officials

  • Holly B Ende, M.D,

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst Professor

Study Record Dates

First Submitted

October 9, 2017

First Posted

November 7, 2017

Study Start

April 1, 2018

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

February 18, 2019

Record last verified: 2019-02

Data Sharing

IPD Sharing
Will not share