To Compare the Efficacy and Patient's Satisfaction From Pain Management of Women After Cesarean Section by Pain Relievers' Administration in Fix Protocol Compared to Protocol Following Demand

Study Overview
=================
Brief Summary
-----------------
Cesarean deliveries are prevalent. Unlike other operations, quick recovery is required for the mother to nurture the newborn child and establishing an appropriate mother-child bonding. Therefore, effective pain management is crucial. In this study we would like to compare between two pain relievers' administration protocols: (1) pain relievers' administration in fix protocol (type of medications, dose and intervals) or (2) pain relievers' administration following demand (the same type and doses, however, medications will be given only following patient's request). The primary outcome will be patient satisfaction, pain control and the necessity of additional medications (rescue doses). The protocols will be used for the first 48 hours following surgery.

Conditions
-----------------
Pain Management, Cesarean Section

Intervention / Treatment
-----------------
* Drug: Fix protocol
* Drug: medications following demand protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women that underwent cesarean section Exclusion Criteria: Women suffering from chronic pain Women using chronic pain medications Allergy to any drug used in the study Women underwent general anesthesia during the surgery women with elevated liver enzymes

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fix protocol<br>During 48 hours following surgery pain medications will be given as followed (listed in brackets are the generic names of each medication): At patient arrival to the department: Intravenous Tramadol hydrochloride 100 milligrams + TAB. Paracetamol 500 milligrams + TAB. Diclofenac 100 milligrams After 6 hours from patient arrival and every 6 hours: TAB. Zaldiar (Paracetamol 650 milligrams + Tramadol 75 milligrams). After 12, 24 and 48 hours from patient arrival: TAB. Diclofenac 100 milligrams. Rescue medication: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)as necessary up to 4 times per day. The total amount of paracetamol is limited to 4 gr per day. | Drug: Fix protocol<br>* Please see arm description<br>|
| Experimental: medications following demand protocol<br>The same combinations will be given as in the fixed protocol however only after patient request | Drug: medications following demand protocol<br>* Please see arm description<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of pain management | Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain | during 48 hours from surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adverse effect of the medications given in each protocol |  | during 48 hours following surgery | 
| to compare the amount of breastfeeding between 2 groups |  | following the week after surgery | 
| The number of times that pain medications were given in each study group |  | during 48 hours following surgery | 
| The necessity of additional medications (rescue doses) |  | During 48 hours after surgery | 
| Patient satisfaction | Each patient will fill in a satisfaction questioner which is given 48 hours after surgery | 48 hours after surgery | 

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