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

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

Overview[ - collapse ][ - ]

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	Pain
Intervention	Drug: Gabapentin Other: lactose
Phase	N/A
Sponsor	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Responsible Party	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

Tracking Information[ + expand ][ + ]

First Received Date	December 12, 2007
Last Updated Date	July 29, 2009
Start Date	November 2007
Estimated Primary Completion Date	February 2009
Current 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]
Current 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]

Descriptive Information[ + expand ][ + ]

Brief Title	The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section
Official Title	The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section: A Randomized Placebo-controlled Trial
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.
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 Type	Interventional
Study Phase	N/A
Study Design	Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Condition	Pain
Intervention	Drug: Gabapentin single oral dose of 600mg gabapentin Other Names: NeurontinOther: lactose Single dose
Study Arm (s)	Active Comparator: 1 Gabapentin Placebo Comparator: 2 Placebo

Recruitment Information[ + expand ][ + ]

Recruitment Status	Terminated
Estimated Enrollment	46
Estimated Completion Date	February 2009
Estimated Primary Completion Date	November 2008
Eligibility 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
Gender	Female
Ages	18 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Canada

Administrative Information[ + expand ][ + ]

NCT Number	NCT00573664
Other Study ID Numbers	07-10
Has Data Monitoring Committee	No
Information Provided By	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Study Sponsor	Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Collaborators	Not Provided
Investigators	Principal Investigator: Jose CA Carvalho, MD Mount Sinai Hospital, New York
Verification Date	July 2009

Locations[ + expand ][ + ]