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

NCT ID: NCT05602038

Last Updated: 2024-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-01
• Study Completion Date: 2023-12-12

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.

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

Conditions

Chronic Post Cesarean Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group Q

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

Group Type: ACTIVE_COMPARATOR

Quadratus laborum block

Intervention Type: 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

intrathecal bupivacaine

Intervention Type: DRUG

intrathecal bupivacaine 0.5% 15mg and fentanyl

Group M

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

Group Type: ACTIVE_COMPARATOR

Intrathecal morphine

Intervention Type: DRUG

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

intrathecal bupivacaine

Intervention Type: DRUG

intrathecal bupivacaine 0.5% 15mg and fentanyl

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

Group Type: ACTIVE_COMPARATOR

Quadratus laborum block

Intervention Type: 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

Intrathecal morphine

Intervention Type: DRUG

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

intrathecal bupivacaine

Intervention Type: DRUG

intrathecal bupivacaine 0.5% 15mg and fentanyl

Group C

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

Group Type: PLACEBO_COMPARATOR

intrathecal bupivacaine

Intervention Type: DRUG

intrathecal bupivacaine 0.5% 15mg and fentanyl

Interventions

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

Intervention Type: PROCEDURE

Intrathecal morphine

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

Intervention Type: DRUG

intrathecal bupivacaine

intrathecal bupivacaine 0.5% 15mg and fentanyl

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Menoufia University

OTHER

Sponsor Role: lead

Responsible Party

rabab Mohammad habeeb

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Menoufia University

Menoufia, Menoufia, Egypt

Countries

Egypt

Other Identifiers

10/2022ANET1-3

Identifier Type: -

Identifier Source: org_study_id