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

Menoufia University

Status: Completed

Conditions: Chronic Post Cesarean Pain

Treatments: Drug: intrathecal bupivacaine; Drug: Intrathecal morphine; Procedure: Quadratus laborum block

Study type: Interventional

Funder types: Other

Identifiers

NCT05602038

10/2022ANET1-3

Details and patient eligibility

About

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.

Full 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

Enrollment: 100 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups, including a placebo group

Group Q

Active Comparator group

Description:

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

Treatment:

Drug: intrathecal bupivacaine

Procedure: Quadratus laborum block

Group M

Active Comparator group

Description:

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

Treatment:

Drug: intrathecal bupivacaine

Drug: Intrathecal morphine

Group QM

Active Comparator group

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

Treatment:

Drug: intrathecal bupivacaine

Procedure: Quadratus laborum block

Drug: Intrathecal morphine

Group C

Placebo Comparator group

Description:

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

Treatment:

Drug: intrathecal bupivacaine