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

Sponsor

Menoufia University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05602038

Collaborator

(none)

100

Enrollment

Arms

10.3

Anticipated Duration (Months)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Post Cesarean Pain	Procedure: Quadratus laborum block Drug: Intrathecal morphine Drug: intrathecal bupivacaine	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

randomized control studyrandomized control study

Masking:

Double (Care Provider, Outcomes 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

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 12, 2023

Arms and Interventions

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 morphine 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
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 morphine 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
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

Outcome Measures

Primary Outcome Measures

Visual analogue scale [Six months]
As zero is no pain and 10 is the maximum pain that can be felt

Secondary Outcome Measures

narcotic consumption [48 hours]
narcotic consumption

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

rabab Mohammad habeeb, Principal investigator, Menoufia University

ClinicalTrials.gov Identifier:

NCT05602038

Other Study ID Numbers:

10/2022ANET1-3

First Posted:

Nov 1, 2022

Last Update Posted:

Jan 25, 2023

Last Verified:

Jan 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

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.:

Additional relevant MeSH terms:

Chronic Pain

Morphine

Bupivacaine

Study Results

No Results Posted as of Jan 25, 2023