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

Pain Clinical Trial

Official title:

The Effectiveness and Safety of Gabapentin for Post-operative Pain After Cesarean Section: A Randomized Placebo-controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00573664
• Other study ID #: 07-10
• Secondary ID: 07-0242-A
• Status: Terminated
• Phase: N/A
• First received: December 12, 2007
• Last updated: July 29, 2009
• Start date: November 2007
• Est. completion date: February 2009

Study information

• Verified date: July 2009
• Source: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 46
• Est. completion date: February 2009
• Est. primary completion date: November 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain
• Pain, Postoperative

Intervention

Drug:
• Gabapentin
single oral dose of 600mg gabapentin

Other:
• lactose
Single dose

Locations

Country	Name	City	State
Canada	Mount Sinai Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.		24 hours	No
Secondary	Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.		48	No
Secondary	Opioid consumption at 4, 12, 24 & 48 hours postoperatively.		48	No
Secondary	Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required.		48 hours	No
Secondary	Time to first maternal request for supplemental analgesia.		48 hours	No
Secondary	Presence of pain 3 months postoperatively.		3 months	No
Secondary	Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission		48 hours	No
Secondary	Neonatal pain response at vitamin K injection (0-100%)		1 hour	No
Secondary	Maternal gabapentin levels (25 patients)		6 months (samples will be stored and sent together)	No