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”

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.

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.

Intervention(s) in this Clinical Trial

• Drug: Gabapentin
  • single oral dose of 600mg gabapentin
• Other: lactose
  • Single dose

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • Gabapentin
• Placebo Comparator: 2
  • Placebo

Primary Measures

• Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
  • Time Frame: 24 hours
    Safety Issue?: No

Secondary Measures

• Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.
  • Time Frame: 48
    Safety Issue?: No
• Opioid consumption at 4, 12, 24 & 48 hours postoperatively.
  • Time Frame: 48
    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
    Safety Issue?: No
• Time to first maternal request for supplemental analgesia.
  • Time Frame: 48 hours
    Safety Issue?: No
• Presence of pain 3 months postoperatively.
  • Time Frame: 3 months
    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
    Safety Issue?: No
• Neonatal pain response at vitamin K injection (0-100%)
  • Time Frame: 1 hour
    Safety Issue?: No
• Maternal gabapentin levels (25 patients)
  • Time Frame: 6 months (samples will be stored and sent together)
    Safety Issue?: No

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 Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 50 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: Accepts Healthy Volunteers

Lead Investigator: Samuel Lunenfeld Research Institute, Mount Sinai Hospital Other

Overall Clinical Trial Officials and Contacts

Jose CA Carvalho, MD Principal Investigator Mount Sinai Hospital, New York  

Information obtained from ClinicalTrials.gov on February 02, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00573664

Study ID Number: 07-10

ClinicalTrials.gov Identifier: NCT00573664

Health Authority: Canada: Ethics Review Committee