Comparative Study on the Effect of Quadratus Lumborum Block Versus Intrathecal Morphine on the Incidence of Chronic Pain Post Caesarean Section in a University Hospital of Middle-income Country

Comparative Study on the Effect of Quadratus Lumborum Block Versus Intrathecal Morphine on the Incidence of Chronic Pain Post Caesarean Section in a University Hospital of Middle-income Country; A Randomized Control Study

The aim of this study is to compare the incidence of CPSCP in patients receiving QLB quadratus lumborum block and ITM versus control as a primary outcome and associated risk factors that might predispose patients to develop CPSCP.

Study Overview

• Status: Completed
• Conditions: Chronic Post Cesarean Pain
• Intervention / Treatment: Procedure: Quadratus laborum block; Drug: intrathecal bupivacaine; Drug: Intrathecal morphine

Detailed Description

The aim of this study is to compare the incidence of chronic post cesarean pain in patients receiving quadratus laborum block and and intrathecal morphine versus control as a primary

Study design:

Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Data will be collected regarding the demographic data, gestational stage, parity and number of previous cesarean section, previous abdominal surgeries, and narcotic consumption.

Postoperative pain day 1 and day2 will be followed by anesthetist who is blinded to the applied technique used. Follow up for the subsequent period of observation (2,4and 6 months) will be done by the department secretary who will contact the patients by phone to ask them if there is any "concern" after the operation. If the patient refers to a pain at the surgical site that has been lasting for the past three months a call will be conducted by the anesthetist and a referral schedule will be appointed to the pain clinic consultant for further evaluation

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: rabab M habeeb; Phone Number: 02 +201001970973; Email: rabab_habeeb@med.menofia.edu.eg

Study Locations

• Egypt
  • Menoufia, Egypt, 32817
    • Menoufia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• patients admitted to the operating theatre for elective caesarean section

Exclusion Criteria:

• lack of informed consent
• Allergy to drugs used during the study
• Depression and epilepsy that required antidepressants or anticonvulsants
• known coagulopathy as a contraindication for spinal anesthesia

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group Q; QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side	Procedure: Quadratus laborum block; quadratus lumborum block will be performed using ultrasound machine (Sonosite Portable Ultrasound System, SonoSite, Bothell, Washington, USA). A 5-8 MHZ curved probe will be used with the patient positioned on the lateral side; Drug: intrathecal bupivacaine; intrathecal bupivacaine 0.5% 15mg and fentanyl
Active Comparator: Group M; Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg	Drug: intrathecal bupivacaine; intrathecal bupivacaine 0.5% 15mg and fentanyl; Drug: Intrathecal morphine; Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg
Active Comparator: Group QM; Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain	Procedure: Quadratus laborum block; quadratus lumborum block will be performed using ultrasound machine (Sonosite Portable Ultrasound System, SonoSite, Bothell, Washington, USA). A 5-8 MHZ curved probe will be used with the patient positioned on the lateral side; Drug: intrathecal bupivacaine; intrathecal bupivacaine 0.5% 15mg and fentanyl; Drug: Intrathecal morphine; Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg
Placebo Comparator: Group C; Control group with intrathecal bupivacaine 0.5% 15mg and fentanyl 20 µg.	Drug: intrathecal bupivacaine; intrathecal bupivacaine 0.5% 15mg and fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual analogue scale	As zero is no pain and 10 is the maximum pain that can be felt	Six months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
narcotic consumption	narcotic consumption	48 hours

Collaborators and Investigators

• Sponsor: Menoufia University

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2023
• Primary Completion (Actual): December 1, 2023
• Study Completion (Actual): December 12, 2023

Study Registration Dates

• First Submitted: October 24, 2022
• First Submitted That Met QC Criteria: October 26, 2022
• First Posted (Actual): November 1, 2022

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Bupivacaine; Morphine
• Other Study ID Numbers: 10/2022ANET1-3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No