Gabapentin for Relief of Immediate Postoperative Pain

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Clinical Phase

PHASE1/PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-02

Study Completion Date

2020-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Gabapentin as Adjunctive Treatment for Postoperative Pain Control

NCT02490345

Drug Usage

COMPLETED PHASE1

The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section

NCT00573664

Pain

TERMINATED NA

The Effectiveness of Gabapentin for Post-operative Pain Following Cesarean Section

NCT01094925

Pain

COMPLETED NA

Single Dose Preoperative Gabapentin Use in Minimally Invasive Hysterectomy for Acute Pain Management

NCT02703259

Pain, Postoperative

COMPLETED PHASE4

Gabapentin Dosages for Postoperative Analgesia Following Open Thoracotomy

NCT05172570

Thoracotomy Pain, Postoperative

TERMINATED PHASE3

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Postoperative Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Randomized 1:1 drug:placebo in blocks of 6 stratified by the hospital, double blind study

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Subjects receiving gabapentin drug

Administration of Gabapentin 600mg orally every 8 hours. Women will receive gabapentin for a total of 48 hours after cesarean

Group Type ACTIVE_COMPARATOR

Gabapentin 600mg

Intervention Type DRUG

Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.

Subjects receiving placebo oral capsule

Administration of identical placebo capsule orally every 8 hours. Women will receive placebo for 48 hours after cesarean

Group Type PLACEBO_COMPARATOR

Placebo oral capsule

Intervention Type DRUG

Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Gabapentin 600mg

Subject is given Gabapentin 600mg every 8 hours x 48 hours postoperatively for pain control.

Intervention Type DRUG

Placebo oral capsule

Subject is given a Placebo capsule every 8 hours x 48 hours postoperatively for pain control.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Pregnant women at least 18 years of age
2. Gestational age \> or = to 30 weeks
3. Singleton gestation
4. Women undergoing a non-emergent cesarean delivery
5. Spinal anesthesia or combined spinal-epidural anesthesia utilized during cesarean
6. Ability to undergo the informed consent process in English

Exclusion Criteria

1. Vertical skin incision
2. General anesthesia for cesarean
3. History of major depression or postpartum depression requiring medication
4. 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.
5. Magnesium sulfate treatment postpartum
6. Preexisting fibromyalgia, chronic pain syndrome, or rheumatologic disorder

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No