To Compare the Efficacy and Patients' Satisfaction for the Treatment of Post Cesarean Pain of Two Protocols: Oral Medications in Fixed Time Interval Administration Versus Spinal Morphine

HaEmek Medical Center, Israel

Status

Completed

Conditions

Post Cesarean Pain Management

Treatments

Drug: Tramadol hydrochloride

Drug: Paracetamol

Drug: Diclofenac

Drug: Morphine

Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)

Study type

Interventional

Funder types

Other

Identifiers

NCT02440399

0028-15

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.

Full description

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:

Oral pain relievers' administration in fix protocol without need for patient demand
Spinal morphine given during the spinal anesthesia in the cesarean section

Enrollment

200 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

women that underwent cesarean section with sinal anesthesia

Exclusion criteria

Women who suffer from chronic pain
Women using chronic pain medications
Women with allergy to any drug used in the study
Women underwent general anesthesia during the surgery
Women who suffer from sleep apnea
Women who suffer from obesity (BMI>40)
Women who suffer from severe nausea and vomiting after previous surgery
Women who received perioperative magnesium
Women who suffer from hypertension
Women who suffer from renal failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

200 participants in 2 patient groups

Fix protocol - Oral treatment

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: