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

Study Overview
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Brief Summary
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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
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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

Official Title
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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; A Randomized Control Study

Conditions
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Chronic Post Cesarean Pain

Intervention / Treatment
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* Procedure: Quadratus laborum block
* Drug: Intrathecal morphine
* Drug: intrathecal bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized control study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group Q<br>QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side | Procedure: Quadratus laborum block<br>* 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<br>Drug: intrathecal bupivacaine<br>* intrathecal bupivacaine 0.5% 15mg and fentanyl<br>|
| Active Comparator: Group M<br>Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg | Drug: Intrathecal morphine<br>* Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg<br>Drug: intrathecal bupivacaine<br>* intrathecal bupivacaine 0.5% 15mg and fentanyl<br>|
| Active Comparator: Group QM<br>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<br>* 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<br>Drug: Intrathecal morphine<br>* Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg<br>Drug: intrathecal bupivacaine<br>* intrathecal bupivacaine 0.5% 15mg and fentanyl<br>|
| Placebo Comparator: Group C<br>Control group with intrathecal bupivacaine 0.5% 15mg and fentanyl 20 µg. | Drug: intrathecal bupivacaine<br>* intrathecal bupivacaine 0.5% 15mg and fentanyl<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual analogue scale | As zero is no pain and 10 is the maximum pain that can be felt | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| narcotic consumption | narcotic consumption | 48 hours |