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

Sponsor:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information provided by:	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
ClinicalTrials.gov Identifier:	NCT00573664

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:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Cesarean Section Nausea and Vomiting

Drug Information available for: Lactose Gabapentin

U.S. FDA Resources

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
1: Active Comparator Gabapentin	Drug: Gabapentin single oral dose of 600mg gabapentin
2: Placebo Comparator 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

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

More Information

No publications provided

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

Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gabapentin
Anti-Dyskinesia Agents
Physiological Effects of Drugs
Psychotropic Drugs
Antiparkinson Agents
Calcium Channel Blockers
Excitatory Amino Acid Agents
Pain
Membrane Transport Modulators
Signs and Symptoms
Pathologic Processes
Sensory System Agents

Therapeutic Uses
Analgesics
Pain, Postoperative
Excitatory Amino Acid Antagonists
Tranquilizing Agents
Central Nervous System Depressants
Cardiovascular Agents
Antimanic Agents
Pharmacologic Actions
Postoperative Complications
Anti-Anxiety Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Anticonvulsants

ClinicalTrials.gov processed this record on February 08, 2010