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

Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Status

Terminated

Conditions

Pain

Treatments

Drug: Gabapentin

Other: lactose

Study type

Interventional

Funder types

Other

Identifiers

NCT00573664

07-10

07-0242-A

Details and patient eligibility

About

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.

Full 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.

Enrollment

46 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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