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

Not Applicable

Completed

• Conditions: Cesarean Section; Pain Management
• Interventions: Drug: medications following demand protocol; Drug: Fix protocol

• Registration Number: NCT01764048
• Lead Sponsor: HaEmek Medical Center, Israel

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11
• Study First Submitted: 2013-01-02
• Study First Submitted QC: 2013-01-07
• Study First Posted: 2013-01-09
• Primary Completion: 2014-01
• Study Completion: 2014-06
• Status Verified: 2016-01
• Last Update Submitted: 2016-01-07
• Last Update Posted: 2016-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 214

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
medications following demand protocol	medications following demand protocol	The same combinations will be given as in the fixed protocol however only after patient request
Fix protocol	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.

Primary Outcome Measures

Name	Time	Method
The efficacy of pain management	during 48 hours from surgery	Pain sensation will be assessed using the VAS scale (visual analog scale) for measurement of acute pain

Secondary Outcome Measures

Name	Time	Method
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
Patient satisfaction	48 hours after surgery	Each patient will fill in a satisfaction questioner which is given 48 hours after surgery
adverse effect of the medications given in each protocol	during 48 hours following surgery
The necessity of additional medications (rescue doses)	During 48 hours after surgery

Trial Locations

Locations (1)

Departement of obstetric and gynecology, HaEmek medical center; 🇮🇱 Afula, Israel