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

This study has been terminated.
(Interim analysis showed a significant reduction in the pain scores)
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital Identifier:
First received: December 12, 2007
Last updated: July 29, 2009
Last verified: July 2009
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 Intervention
Pain Drug: Gabapentin Other: lactose

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:

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

Secondary Outcome Measures:
  • Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 ]
  • Opioid consumption at 4, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 ]
  • 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 ]
  • Time to first maternal request for supplemental analgesia. [ Time Frame: 48 hours ]
  • Presence of pain 3 months postoperatively. [ Time Frame: 3 months ]
  • Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission [ Time Frame: 48 hours ]
  • Neonatal pain response at vitamin K injection (0-100%) [ Time Frame: 1 hour ]
  • Maternal gabapentin levels (25 patients) [ Time Frame: 6 months (samples will be stored and sent together) ]

Enrollment: 46
Study Start Date: November 2007
Study Completion Date: February 2009
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Drug: Gabapentin
single oral dose of 600mg gabapentin
Other Name: Neurontin
Placebo Comparator: 2
Other: lactose
Single dose

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.


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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00573664

Canada, Ontario
Mount Sinai Hospital
Toronto, Ontario, Canada, M5G 1X5
Sponsors and Collaborators
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
  More Information

Responsible Party: Dr. Jose C.A. Carvalho, Mount Sinai Hospital Identifier: NCT00573664     History of Changes
Other Study ID Numbers: 07-10
Study First Received: December 12, 2007
Last Updated: July 29, 2009

Keywords provided by Samuel Lunenfeld Research Institute, Mount Sinai Hospital:
Cesarean section

Additional relevant MeSH terms:
Pain, Postoperative
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
gamma-Aminobutyric Acid
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents
GABA Agents processed this record on September 21, 2017