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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00573664
Recruitment Status : Terminated (Interim analysis showed a significant reduction in the pain scores)
First Posted : December 14, 2007
Last Update Posted : July 30, 2009
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

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
Pain Drug: Gabapentin Other: lactose Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
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 : November 2007
Actual Primary Completion Date : November 2008
Actual Study Completion Date : February 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arm Intervention/treatment
Active Comparator: 1
Drug: Gabapentin
single oral dose of 600mg gabapentin
Other Name: Neurontin

Placebo Comparator: 2
Other: lactose
Single dose

Primary Outcome Measures :
  1. Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. [ Time Frame: 24 hours ]

Secondary Outcome Measures :
  1. Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 ]
  2. Opioid consumption at 4, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 ]
  3. Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required. [ Time Frame: 48 hours ]
  4. Time to first maternal request for supplemental analgesia. [ Time Frame: 48 hours ]
  5. Presence of pain 3 months postoperatively. [ Time Frame: 3 months ]
  6. Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission [ Time Frame: 48 hours ]
  7. Neonatal pain response at vitamin K injection (0-100%) [ Time Frame: 1 hour ]
  8. Maternal gabapentin levels (25 patients) [ Time Frame: 6 months (samples will be stored and sent together) ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00573664

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Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
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Principal Investigator: Jose CA Carvalho, MD MOUNT SINAI HOSPITAL

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Responsible Party: Dr. Jose C.A. Carvalho, Mount Sinai Hospital Identifier: NCT00573664     History of Changes
Other Study ID Numbers: 07-10
First Posted: December 14, 2007    Key Record Dates
Last Update Posted: July 30, 2009
Last Verified: July 2009
Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Cesarean section
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Neurologic Manifestations
Signs and Symptoms
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antimanic Agents