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

Sponsor
Samuel Lunenfeld Research Institute, Mount Sinai Hospital (Other)
Overall Status
Terminated
CT.gov ID
NCT00573664
Collaborator
(none)
46
Enrollment
1
Location
2
Arms
15
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

Detailed Description

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section: A Randomized Placebo-controlled Trial
Study Start Date :
Nov 1, 2007
Actual Primary Completion Date :
Nov 1, 2008
Actual Study Completion Date :
Feb 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 1

Gabapentin

Drug: Gabapentin
single oral dose of 600mg gabapentin
Other Names:
  • Neurontin

    		•
    Placebo Comparator: 2

    Placebo

    Other: lactose
    Single dose

    Outcome Measures

    Primary Outcome Measures

    1. Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. [24 hours]

    Secondary Outcome Measures

    1. Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively. [48]

    2. Opioid consumption at 4, 12, 24 & 48 hours postoperatively. [48]

    3. Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required. [48 hours]

    4. Time to first maternal request for supplemental analgesia. [48 hours]

    5. Presence of pain 3 months postoperatively. [3 months]

    6. Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission [48 hours]

    7. Neonatal pain response at vitamin K injection (0-100%) [1 hour]

    8. Maternal gabapentin levels (25 patients) [6 months (samples will be stored and sent together)]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 50 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mount Sinai Hospital Toronto Ontario Canada M5G 1X5

    Sponsors and Collaborators

    • Samuel Lunenfeld Research Institute, Mount Sinai Hospital

    Investigators

    • Principal Investigator: Jose CA Carvalho, MD, MOUNT SINAI HOSPITAL

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    , ,
    ClinicalTrials.gov Identifier:
    NCT00573664
    Other Study ID Numbers:
    • 07-10
    • 07-0242-A
    First Posted:
    Dec 14, 2007
    Last Update Posted:
    Jul 30, 2009
    Last Verified:
    Jul 1, 2009
    Keywords provided by , ,
    Cesarean section
    Gabapentin
    Additional relevant MeSH terms:
    Pain, Postoperative
    Gabapentin

    Study Results

    No Results Posted as of Jul 30, 2009