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

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 200
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • HaEmek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Paracetamol; Drug: Diclofenac; Drug: Tramadol hydrochloride; Please see arm description; Drug: TAB. Percocet (Oxycodone 5MG/Paracetamol 325 MG)
Experimental: Spinal morphine; The women will receive 150 mcg morphine with the spinal anesthesia given in the cesarean section	Drug: Morphine; Please see arm description

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient satisfaction	Each patient will fill in a satisfaction questioner which is given 48 hours after surgery	48 hours after surgery
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
The efficacy of pain management during 4 days past surgery	Pain sensation will be assessed using the VAS scale	during 4 days past surgery

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel

Publications and helpful links

General Publications

• Yefet E, Nassar S, Carmeli J, Massalha M, Hasanein J, Zafran N, Rudin M, Nachum Z. Oral analgesia in fixed-time interval administration versus spinal morphine for post-Cesarean pain: a randomised controlled trial. Arch Gynecol Obstet. 2022 Apr;305(4):893-901. doi: 10.1007/s00404-021-06196-3. Epub 2021 Aug 31.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): May 1, 2017
• Study Completion (Actual): May 1, 2017

Study Registration Dates

• First Submitted: May 7, 2015
• First Submitted That Met QC Criteria: May 8, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Actual): May 9, 2017
• Last Update Submitted That Met QC Criteria: May 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antipyretics; Analgesics, Opioid; Narcotics; Acetaminophen; Morphine; Diclofenac; Tramadol; Oxycodone
• Other Study ID Numbers: 0028-15