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

NCT05602038 | Completed

• 1 other identifier: 10/2022ANET1-3
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Chronic Post Cesarean Pain

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  As zero is no pain and 10 is the maximum pain that can be felt

  Six months

Secondary Outcomes (1)

• narcotic consumption

  48 hours

Study Arms (4)

Group Q

ACTIVE COMPARATOR

QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side

Procedure: Quadratus laborum block; Drug: intrathecal bupivacaine

Group M

ACTIVE COMPARATOR

Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg

Drug: Intrathecal morphine; Drug: intrathecal bupivacaine

Group QM

ACTIVE COMPARATOR

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; Drug: Intrathecal morphine; Drug: intrathecal bupivacaine

Group C

PLACEBO COMPARATOR

Control group with intrathecal bupivacaine 0.5% 15mg and fentanyl 20 µg.

Drug: intrathecal bupivacaine

Interventions

Quadratus laborum block PROCEDURE

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

Group Q; Group QM

Intrathecal morphine DRUG

Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg

Group M; Group QM

intrathecal bupivacaine DRUG

intrathecal bupivacaine 0.5% 15mg and fentanyl

Group C; Group M; Group Q; Group QM

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Post operative cesarean section pain
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• patients admitted to the operating theatre for elective caesarean section

You may not qualify if:

• 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

Sponsors & Collaborators

• Menoufia University: lead

Study Sites (1)

Menoufia University

Menoufia, Menoufia, 32817, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: randomized control study

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 1, 2022
• Study Start: February 1, 2023
• Primary Completion: December 1, 2023
• Study Completion: December 12, 2023
• Last Updated: January 31, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)