Clinical trial NCT00573664: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Keywords: Cesarean section
Gabapentin
Lead sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Sponsor class: OTHER
First posted: 2007-12-14
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.
timeFrame: 24 hours
Secondary outcomes:
measure: Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.
timeFrame: 48
measure: Opioid consumption at 4, 12, 24 & 48 hours postoperatively.
timeFrame: 48
measure: Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required.
timeFrame: 48 hours
measure: Time to first maternal request for supplemental analgesia.
timeFrame: 48 hours
measure: Presence of pain 3 months postoperatively.
timeFrame: 3 months
measure: Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission
timeFrame: 48 hours
measure: Neonatal pain response at vitamin K injection (0-100%)
timeFrame: 1 hour
measure: Maternal gabapentin levels (25 patients)
timeFrame: 6 months (samples will be stored and sent together)
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: MOUNT SINAI HOSPITAL
name: Jose CA Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References: