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

Not Applicable

Completed

• Conditions: Post Cesarean Pain Management
• Interventions: Drug: Tramadol hydrochloride; Drug: Morphine; Drug: Paracetamol; Drug: Diclofenac; Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)

• Registration Number: NCT02440399
• 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.

Detailed 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:

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 Timeline

• Study First Submitted: 2015-05-07
• Study First Submitted QC: 2015-05-08
• Study First Posted: 2015-05-12
• Study Start: 2015-07
• Status Verified: 2017-05
• Primary Completion: 2017-05
• Study Completion: 2017-05
• Last Update Submitted: 2017-05-08
• Last Update Posted: 2017-05-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fix protocol - Oral treatment	TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)	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.
Fix protocol - Oral treatment	Tramadol hydrochloride	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.
Fix protocol - Oral treatment	Paracetamol	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.
Fix protocol - Oral treatment	Diclofenac	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.
Spinal morphine	Morphine	The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patient satisfaction	48 hours after surgery	Each patient will fill in a satisfaction questioner which is given 48 hours after surgery
The efficacy of pain management during 4 days past surgery	during 4 days past surgery	Pain sensation will be assessed using the VAS scale
The necessity of additional medications (rescue doses)	During 48 hours after surgery
Adverse effect of the medications given in each protocol on the mother and neonates	during 48 hours following surgery
To compare the amount of breastfeeding between 2 groups	Following the week after surgery
Total amount of pain medications required in each study group	during 48 hours following surgery and after 7 days

Trial Locations

Locations (1)

Haemek Medical Center; 🇮🇱 Afula, Israel