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, Israel200 enrolled

Overview

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.

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. Oral pain relievers' administration in fix protocol without need for patient demand 2. Spinal morphine given during the spinal anesthesia in the cesarean section

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

200

Conditions

Post Cesarean Pain Management

Interventions

Tramadol hydrochlorideDRUG

Please see arm description

MorphineDRUG

Please see arm description

ParacetamolDRUG

DiclofenacDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Haemek Medical Center

Afula, Israel

Outcomes

Primary Outcomes

The efficacy of pain management

Pain sensation will be assessed using the NRS scale (numeric rating scale) for measurement of acute pain

Time frame: during 48 hours from surgery

Secondary Outcomes

Patient satisfaction

Each patient will fill in a satisfaction questioner which is given 48 hours after surgery

Time frame: 48 hours after surgery

The necessity of additional medications (rescue doses)

Time frame: During 48 hours after surgery

Adverse effect of the medications given in each protocol on the mother and neonates

Time frame: during 48 hours following surgery

To compare the amount of breastfeeding between 2 groups

Time frame: Following the week after surgery

Total amount of pain medications required in each study group

Time frame: during 48 hours following surgery and after 7 days

The efficacy of pain management during 4 days past surgery

Pain sensation will be assessed using the VAS scale

Time frame: during 4 days past surgery

Data from ClinicalTrials.gov

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