Does a Perioperative Course of Gabapentin Improve Analgesia After Cesarean Delivery?

NCT01848119 | Completed

• 1 other identifier: 13-01
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 1

Brief Summary

Gabapentin has been very effective at treating pain after knee and hip operations, hysterectomies, and many other types of operations. A previous study at the investigators' hospital found that a single pre-operative dose of 600mg gabapentin produced a significant reduction in pain after cesarean section. However, 19% of patients complained of sedation. A subsequent study at the same institution looked to see if lowering the dose to 300mg would decrease pain scores whilst reducing the sedative side-effect seen in the first trial. The results were inconclusive but it provided valuable information to guide the design of this study. The purpose of this study is to see whether a preoperative dose of gabapentin, followed by a 48 hour low-dose course will produce improvement in pain scores. This study will compare the efficacy of a peri-operative course of gabapentin (600mg one hour before the operation and 200mg every 8 hours for 2 days post-operatively) and a similar course of placebo in women undergoing Cesarean section. The investigators' hypothesis is that a course of gabapentin will result in decreased pain scores and increased satisfaction.

Conditions

Pain

Keywords

Gabapentin; Cesarean section

Outcome Measures

Primary Outcomes (1)

• VAS score (VAS 0-100 mm) for maternal pain on movement at 24 hours after surgical incision.

  24 hours

Secondary Outcomes (11)

• VAS score on movement at 48 hours after surgical incision

  48 hours

• VAS scores at rest at 24 and 48 hours after surgical incision

  48 hours

• Maternal satisfaction scores at 24 and 48 hours after surgical incision.

  48 hours

• Opioid use in the first 48 hours after surgical incision

  48 hours

• Time to first analgesic

  48 hours

Study Arms (2)

Gabapentin

ACTIVE COMPARATOR

Gabapentin 600mg, 1 dose preoperatively, followed by Gabapentin 200mg tid for 5 doses.

Drug: Gabapentin

Placebo

PLACEBO COMPARATOR

lactose capsules

Drug: lactose

Interventions

Gabapentin DRUG

Also known as: Novo-gabapentin, Neurontin

Gabapentin

lactose DRUG

Placebo

Eligibility Criteria

• Age: 16 Years - 55 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• All women aged 16 years and over with term singleton pregnancies undergoing elective cesarean delivery at Mount Sinai Hospital under spinal anesthesia, who have given pre-operative informed written consent will be eligible to participate in this study

You may not qualify if:

• Patients who have refused, are unable to give or have withdrawn consent
• Patients unable to communicate fluently in English
• Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater
• Patients with history of epilepsy or chronic pain, or of use of anti-epileptic drugs or neuropathic analgesic drugs
• Patients with a history of opioid or intravenous drug abuse
• Patients with a known allergy or contra-indication to gabapentin, or to any other drugs used in this trial
• Patients who have refused spinal anaesthesia, or those in whom it is contra-indicated
• Patients with known congenital fetal abnormalities
• Patients who have taken antacid medication in the previous 24 hours

Sponsors & Collaborators

• Samuel Lunenfeld Research Institute, Mount Sinai Hospital: lead

Study Sites (1)

Mount Sinai Hospital

Toronto, Ontario, M5G1X5, 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
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2013
• First Posted: May 7, 2013
• Study Start: May 1, 2013
• Primary Completion: December 1, 2013
• Study Completion: February 1, 2014
• Last Updated: October 13, 2014

Record last verified: 2014-10

Locations

CA (1)