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Does a Perioperative Course of Gabapentin Improve Analgesia After Cesarean Delivery?

NCT01848119 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 204

Last updated 2014-10-13

No results posted yet for this study

Summary

Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of operations. A previous study at the investigators' hospital found that a single pre-operative dose of 600mg gabapentin produced a significant reduction in pain after cesarean section. However, 19% of patients complained of sedation. A subsequent study at the same institution looked to see if lowering the dose to 300mg would decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The results were inconclusive but it provided valuable information to guide the design of this study.

The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a 48 hour low-dose course will produce improvement in pain scores. This study will compare the efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and 200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin will result in decreased pain scores and increased satisfaction.

Conditions

Interventions

DRUG

Gabapentin

DRUG

lactose

Sponsors & Collaborators

  • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    lead OTHER

Principal Investigators

  • Jose CA Carvalho, MD · MOUNT SINAI HOSPITAL

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
55 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-05-31
Primary Completion
2013-12-31
Completion
2014-02-28

Countries

  • Canada

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01848119 on ClinicalTrials.gov