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

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.

Study Overview

• Status: Completed
• Conditions: Cesarean Section; Pain Management
• Intervention / Treatment: Drug: Fix protocol; Drug: medications following demand protocol

• Study Type: Interventional
• Enrollment (Actual): 214
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel, 18101
    • Departement of obstetric and gynecology, HaEmek medical center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fix protocol; 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; Please see arm description
Experimental: medications following demand protocol; The same combinations will be given as in the fixed protocol however only after patient request	Drug: medications following demand protocol; Please see arm description

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
Patient satisfaction	Each patient will fill in a satisfaction questioner which is given 48 hours after surgery	48 hours after surgery
The necessity of additional medications (rescue doses)		During 48 hours after surgery
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

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): June 1, 2014

Study Registration Dates

• First Submitted: January 2, 2013
• First Submitted That Met QC Criteria: January 7, 2013
• First Posted (Estimate): January 9, 2013

Study Record Updates

• Last Update Posted (Estimate): January 8, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: cesarean section; pain management
• Other Study ID Numbers: 0120-12-EMC