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

NCT00573664 | Terminated

• 2 other identifiers: 07-1007-0242-A
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain

Keywords

Cesarean section; Gabapentin

Outcome Measures

Primary Outcomes (1)

• Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively.

  24 hours

Secondary Outcomes (8)

• Pain at rest and on movement by VAS at 4, 12, 24 & 48 hours postoperatively.

  48

• Opioid consumption at 4, 12, 24 & 48 hours postoperatively.

  48

• Assessment of sedation, pruritis, nausea, vomiting and dizziness on a 4-point scale (absent, mild, moderate, severe) and document treatment if required.

  48 hours

• Time to first maternal request for supplemental analgesia.

  48 hours

• Presence of pain 3 months postoperatively.

  3 months

Study Arms (2)

1

ACTIVE COMPARATOR

Gabapentin

Drug: Gabapentin

2

PLACEBO COMPARATOR

Placebo

Other: lactose

Interventions

Gabapentin DRUG

single oral dose of 600mg gabapentin

Also known as: Neurontin

1

lactose OTHER

Single dose

2

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Women undergoing elective cesarean delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Pain

Interventions

Gabapentin; Lactose

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Amines; Organic Chemicals; gamma-Aminobutyric Acid; Aminobutyrates; Butyrates; Acids, Acyclic; Carboxylic Acids; Cyclohexanecarboxylic Acids; Acids, Carbocyclic; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Amino Acids; Amino Acids, Peptides, and Proteins; Disaccharides; Oligosaccharides; Polysaccharides; Carbohydrates; Sugars

Study Officials

• Jose CA Carvalho, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 12, 2007
• First Posted: December 14, 2007
• Study Start: November 1, 2007
• Primary Completion: November 1, 2008
• Study Completion: February 1, 2009
• Last Updated: July 30, 2009

Record last verified: 2009-07

Locations

CA (1)