Does Pregabalin Improve Post-operative Pain After C-section Delivery

Study Overview
=================
Brief Summary
-----------------
Pregabalin due to its antihyperalgesic effect, has proven its efficacy on neuropathic pain, essentially in nociceptive surgeries. Few studies have attempted to identify the utility of pregabalin as a premedication before cesarean delivery. The investigators aimed to determine whether or not pregabalin as premedication improves analgesia post cesarean delivery.

Detailed Description
-----------------
The investigators conducted a controlled, randomised, prospective and double-blind trial. One hundred thirty eight participants were included, with American Society of Anesthesiologists physical status classification of I to II, with pregnancies of at least 36 weeks of gestation who were scheduled for elective caesarean delivery under spinal anaesthesia. One hour before induction of anaesthesia participants received a capsule containing sugar placebo (placebo group), pregabalin 150 mg or pregabalin 300 mg. Data related to surgical history, pre-existing medical problems, indications for cesarean and peroperative hemodynamic changes were analyzed. The primary outcome was first analgesic request. Secondary outcomes included maternal pain scores at rest and during movement, rescue analgesics consumption, sedation, nausea, vomiting, pruritus and Apgar scores. All maternal secondary outcome variables were recorded 0, 2, 4, 6, 12, 18, and 24 h after delivery. Common side effects linked to pregabalin such as somnolence, blurred or abnormal vision, or fetal distress were collected.

Official Title
-----------------
Does Pregabalin Improve Post-operative Pain After C-section Delivery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Pregabalin 150mg
* Drug: Placebos
* Drug: Pregabalin 300mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists class I or II single pregnancies at term under spinal anesthesia Exclusion Criteria: conversion to general anesthesia post partum hemorrhage requiring specific resuscitation local anesthetic toxicity violation of the protocol

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Group C<br>two capsules filled with sugar | Drug: Placebos<br>* two capsules filled with sugar ingested orally one hour before cesarean section<br>* Other names: C;|
| Active Comparator: Group P150<br>two capsules; one of them containing sugar (like the placebo one), the other is the active drug (pregabalin 150 mg) | Drug: Pregabalin 150mg<br>* two capsules, one is placebo, the other correspond to pregabalin 150 mg ingested orally one hour before cesarean section<br>* Other names: P150;|
| Active Comparator: Group P300<br>two capsules of pregabalin (150 mg) | Drug: Pregabalin 300mg<br>* two capsules of pregabalin 150 mg ingested orally one hour before cesarean section<br>* Other names: P300;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first analgesic request | in minutes, the time between the end of the operation to the first demand of analgesics | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analog scale (VAS) at rest and movement | Checked at hours 2, 4, 6,12,18 and 24 post operatively | 24 hours | 
| Maternal satisfaction | Measured by a Visual Analog Scale, ranging from 0 to 100; 0=not satisfied at all | 24 hours | 
| Maternal consumption of paracetamol postoperatively | grams | 24 hours | 
| Apgar scores | Ranging from 0 to 10; 7 to 10 correspond to an excellent condition | 1 and 5 minutes after birth | 
| Heart rate | beats per minute | Per operative period | 
| Non-invasive blood pressure | measured in millimeters of mercury | Per operative period | 
| Visual disturbances | present or not | 24 hours post operatively | 
| Fluids administered to the mother per operatively | in milliliters | Per operative period | 
| Dose of ephedrine administered to the mother per operatively | in milligrams | Per operative period | 
| Ramsay score for sedation | Ranging from 1 to 6 | 24 hours post operatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative pain, pregabalin, cesarean section