Postoperative Cesarean Delivery Pain Relief; Diclofenac Versus Bupivacaine

Study Overview
=================
Brief Summary
-----------------
This randomized controlled trial, compared postoperative pain score in patient undergoing cesarean delivery between bupivacaine peritoneal and subcutaneous infiltration and diclofenac intramuscular injection

Detailed Description
-----------------
Postoperative cesarean delivery was painful that can effect daily activity, resulted in poor quality of life and required morphine injection to relief pain which had both maternal and breastfeeding infancy side effect. So this study compare efficacy of diclofenac and bupivacaine by measured the pain score and requirement of morphine injection.

Official Title
-----------------
A Randomized Comparison of Bupivacaine Peritoneal and Subcutaneous Infiltration Versus Diclofenac Intramuscular Injection for Postoperative Pain Relief in Patient Undergoing Cesarean Delivery

Conditions
-----------------
Cesarean Delivery

Intervention / Treatment
-----------------
* Drug: Bupivacaine
* Drug: Diclofenac


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergo elective or urgency cesarean delivery at Rajavithi Hospital in 2016-2017 Urgency conditions: CPD, fail induction of labor, antepartum hemorrhage without hypovolemic shock, dystocia, previous cesarean section and active labor, malpresentation in labor, macrosomic presentation in labor Pregnant women more than 20 years of age Gestational age more than 37 week Cesarean section under regional or general anesthesia Ability to communicating, writing and reading Thai language Exclusion Criteria: Inability to communicating or writing or reading Thai language Contraindicated to bupivacaine or diclofenac or morphine Pregnant women with emergency conditions Have one or more complication of pregnancy Intraoperative arrhythmia Pregnant women less than 20 years of age Regional anesthesia with morphine

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group Bupivacaine<br>0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration | Drug: Bupivacaine<br>* 0.5% bupivacaine 20ml divided in two; 10 ml intraperitoneal infiltration and 10 ml subcutaneous infiltration<br>|
| Active Comparator: Group Diclofenac<br>diclofenac 75 mg intramuscular, 2 hours postoperation | Drug: Diclofenac<br>* diclofenac 75 mg intramuscular, 2 hours postoperation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compared pain score change from baseline at 2, 6 and 24 hours at post-operation between 2 groups by visual analogue scale |  | 2, 6 and 24 hours post-operation | 
| Compared rescued dose of morphine injection |  | Within 24 hours post-operation |