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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Pain

Intervention / Treatment
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* Drug: Gabapentin
* Other: lactose


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Gabapentin | Drug: Gabapentin<br>* single oral dose of 600mg gabapentin<br>* Other names: Neurontin;|
| Placebo Comparator: 2<br>Placebo | Other: lactose<br>* Single dose<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score by visual analogue scale (VAS) on movement at 24 hours postoperatively. |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Neonatal information: Apgar scores, arterial cord blood gases, arterial and venous cord blood gabapentin concentration, need for NICU admission |  | 48 hours | 
| Neonatal pain response at vitamin K injection (0-100%) |  | 1 hour | 
| Maternal gabapentin levels (25 patients) |  | 6 months (samples will be stored and sent together) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cesarean section, Gabapentin