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)
Sponsor:
Information provided by:
Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:
NCT00573664
First received: December 12, 2007
Last updated: July 29, 2009
Last verified: July 2009
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 ] [ Designated as safety issue: No ]
  • Opioid consumption at 4, 12, 24 & 48 hours postoperatively. [ Time Frame: 48 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to first maternal request for supplemental analgesia. [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Presence of pain 3 months postoperatively. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
  • Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission [ Time Frame: 48 hours ] [ Designated as safety issue: No ]
  • Neonatal pain response at vitamin K injection (0-100%) [ Time Frame: 1 hour ] [ Designated as safety issue: No ]
  • Maternal gabapentin levels (25 patients) [ Time Frame: 6 months (samples will be stored and sent together) ] [ Designated as safety issue: No ]

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
Gabapentin
Drug: Gabapentin
single oral dose of 600mg gabapentin
Other Name: Neurontin
Placebo Comparator: 2
Placebo
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.

  Eligibility

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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00573664

Locations
Canada, Ontario
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, New York
  More Information

No publications provided

Responsible Party: Dr. Jose C.A. Carvalho, Mount Sinai Hospital
ClinicalTrials.gov Identifier: NCT00573664     History of Changes
Other Study ID Numbers: 07-10, 07-0242-A
Study First Received: December 12, 2007
Last Updated: July 29, 2009
Health Authority: Canada: Ethics Review Committee
Canada: Health Canada

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

Additional relevant MeSH terms:
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Signs and Symptoms
Gabapentin
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anticonvulsants
Antiparkinson Agents
Anti-Dyskinesia Agents
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Anti-Anxiety Agents
Tranquilizing Agents
Central Nervous System Depressants
Psychotropic Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Antimanic Agents

ClinicalTrials.gov processed this record on September 18, 2014