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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2017-05-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Post Cesarean Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Fix protocol - Oral treatment

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.

Group Type EXPERIMENTAL

Tramadol hydrochloride

Intervention Type DRUG

Please see arm description

Paracetamol

Intervention Type DRUG

Diclofenac

Intervention Type DRUG

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

Intervention Type DRUG

Spinal morphine

The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section

Group Type EXPERIMENTAL

Morphine

Intervention Type DRUG

Please see arm description

Interventions

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Tramadol hydrochloride

Please see arm description

Intervention Type DRUG

Morphine

Please see arm description

Intervention Type DRUG

Paracetamol

Intervention Type DRUG

Diclofenac

Intervention Type DRUG

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No