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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

Primary Purpose

Chronic Post Cesarean Pain

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Quadratus laborum block

Intrathecal morphine

intrathecal bupivacaine

About this trial

This is an interventional treatment trial for Chronic Post Cesarean Pain

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group Q

Group M

Group QM

Group C

Arm Description

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

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

Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain

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

Outcomes

Primary Outcome Measures

Visual analogue scale

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

Secondary Outcome Measures

narcotic consumption

Full Information

NCT ID

NCT05602038

First Posted

October 24, 2022

Last Updated

January 22, 2023

Sponsor

Menoufia University

1. Study Identification

Unique Protocol Identification Number

NCT05602038

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Not yet recruiting

Study Start Date

February 1, 2023 (Anticipated)

Primary Completion Date

December 1, 2023 (Anticipated)

Study Completion Date

December 12, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Menoufia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Post Cesarean Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

randomized control study

Masking

Care ProviderOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group Q

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group M

Arm Type

Active Comparator

Arm Description

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

Arm Title

Group QM

Arm Type

Active Comparator

Arm Description

Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain

Arm Title

Group C

Arm Type

Placebo Comparator

Arm Description

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

Intervention Type

Procedure

Intervention Name(s)

Quadratus laborum block

Intervention Description

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

Drug

Intervention Name(s)

Intrathecal morphine

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

intrathecal bupivacaine

Intervention Description

intrathecal bupivacaine 0.5% 15mg and fentanyl

Primary Outcome Measure Information:

Title

Visual analogue scale

Description

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

Time Frame

Six months

Secondary Outcome Measure Information:

Title

narcotic consumption

Description

narcotic consumption

Time Frame

48 hours

10. Eligibility

Sex

Female

Gender Based

Yes

Gender Eligibility Description

Post operative cesarean section pain

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

rabab M habeeb

Phone

+201001970973

Ext

rabab_habeeb@med.menofia.edu.eg

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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