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

HaEmek Medical Center, Israel

Status: Completed

Conditions: Cesarean Section; Pain Management

Treatments: Drug: Fix protocol; Drug: medications following demand protocol

Study type: Interventional

Funder types: Other

Identifiers

NCT01764048

0120-12-EMC

Details and patient eligibility

About

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.

Enrollment: 214 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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214 participants in 2 patient groups

Fix protocol

Experimental group

Description:

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.

Treatment:

Drug: Fix protocol

medications following demand protocol

Experimental group

Description:

The same combinations will be given as in the fixed protocol however only after patient request

Treatment:

Drug: medications following demand protocol