The Effectiveness and Safety of Gabapentin for Post-Operative Pain After Cesarean Section
Information source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Pain
Intervention: Gabapentin (Drug); lactose (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Official(s) and/or principal investigator(s):
Jose CA Carvalho, MD, Principal Investigator, Affiliation: MOUNT SINAI HOSPITAL
Overall contact:
Jose CA Carvalho, MD, Phone: 416-586-4800, Ext: 2681, Email: jose.carvalho@uhn.on.ca
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.
Clinical Details
Official title: The Effectiveness and Safety of Gabapentin for Post-Operative Pain After Cesarean Section: A Randomized Placebo-Controlled Trial
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
Secondary outcome: Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.Opioid consumption at 4, 12, 24 & 48 hours postoperatively. Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required. Time to first maternal request for supplemental analgesia. Presence of pain 3 months postoperatively. Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission Neonatal pain response at vitamin K injection (0-100%) Maternal gabapentin levels (25 patients)
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
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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
Locations and Contacts
Jose CA Carvalho, MD, Phone: 416-586-4800, Ext: 2681, Email: jose.carvalho@uhn.on.ca
Mount Sinai Hospital, Toronto, Ontario M5G 1X5, Canada; Recruiting
Jose CA Carvalho, MD, Phone: 416-586-4800, Ext: 2681, Email: jose.carvalho@uhn.on.ca
Albert Moore, MD, Sub-Investigator
Joseph Costello, MD, Sub-Investigator
Vibhuti Shah, MD, Sub-Investigator
Anna Taddio, MD, Sub-Investigator
Additional Information
Starting date: November 2007
Ending date: October 2009
Last updated: November 13, 2008
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