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

NCT ID: NCT00573664

Last Updated: 2009-07-30

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

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-02-28

Brief Summary

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The purpose of this study is to determine whether a single dose of gabapentin, given before cesarean section, will reduce pain in the initial 24 hours after surgery. Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of surgeries. We believe that it may be effective for treating pain after cesarean sections, but it has never been studied for this purpose.

Detailed Description

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A cesarean section is a surgical procedure and, like all surgeries, there is pain after the operation. The purpose of this study is to find out if patients have less pain after a cesarean delivery when they receive a single dose of a gabapentin before the surgery. We are also interested in whether or not the dose of gabapentin reduces the need for other pain-killing medication during this time.

Patients will be randomly assigned to receive either gabapentin or a placebo. In addition, all patients will receive the usual standard of care and medication for pain (intrathecal morphine,oral paracetamol and diclofenac). At 4, 12, 24 and 48 hours after the operation, patients will be asked about their pain and satisfaction with pain management. The dose of gabapentin given is thought to be safe for the baby, and we plan to investigate whether the gabapentin has any effect on the baby's pain response when given his/her vitamin K injection. Gabapentin has also been shown to reduce long-term pain that can develop, and patients will be followed up at 6 weeks to be asked about their pain at that time.

Conditions

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Pain

Keywords

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Cesarean section Gabapentin

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

Gabapentin

Group Type ACTIVE_COMPARATOR

Gabapentin

Intervention Type DRUG

single oral dose of 600mg gabapentin

2

Placebo

Group Type PLACEBO_COMPARATOR

lactose

Intervention Type OTHER

Single dose

Interventions

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Gabapentin

single oral dose of 600mg gabapentin

Intervention Type DRUG

lactose

Single dose

Intervention Type OTHER

Other Intervention Names

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Neurontin

Eligibility Criteria

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Inclusion Criteria

* Women undergoing elective cesarean delivery

Exclusion Criteria

* Patients unable to communicate in English
* Patients with an American Society of Anesthesiologists (ASA) classification of 3 or higher
* Patients with contraindications to any of the medications used in the study
* Patients with contraindications to spinal anesthesia
* Patients who have taken any pain medication in the past week
* Patients with fetuses having congenital abnormalities
* Patients with severe mental disorders
* Patients with HIV or hepatitis infections
* Intravenous drug users
* Patients with uncontrolled hypertension and diabetes
* Patients with central nervous system tumours
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Samuel Lunenfeld Research Institute, Mount Sinai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mount Sinai Hospital

Principal Investigators

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Jose CA Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

MOUNT SINAI HOSPITAL

Locations

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Mount Sinai Hospital

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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07-0242-A

Identifier Type: -

Identifier Source: secondary_id

07-10

Identifier Type: -

Identifier Source: org_study_id