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

Pain research study

What is the primary objective of this study?

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.

Who is eligible to participate?

Inclusion Criteria: - 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be eligible to participate in this study Exclusion Criteria: - Patients who have refused, are unable to give or have withdrawn consent - Patients unable to communicate fluently in English - Patients with American Society of Anesthesiologists (ASA) classification of 3 or greater -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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Pain

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Gabapentin

Drug:lactose

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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

Placebolactose capsules

Study Status

Completed

Start Date: May 2013

Completed Date: February 2014

Phase: N/A

Type: Interventional

Design:

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

Secondary Outcome: VAS score on movement at 48 hours after surgical incision

Study sponsors, principal investigator, and references

Principal Investigator: Jose CA Carvalho, MD

Lead Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01848119

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