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
- Conditions
- Chronic Post Cesarean Pain
- Interventions
- Registration Number
- NCT05602038
- Lead Sponsor
- Menoufia University
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 100
- patients admitted to the operating theatre for elective caesarean section
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Group Q intrathecal bupivacaine QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side Group C intrathecal bupivacaine Control group with intrathecal bupivacaine 0.5% 15mg and fentanyl 20 µg. Group QM intrathecal bupivacaine 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 M intrathecal bupivacaine Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg Group Q Quadratus laborum block QLB group will receive 30 ml 0.125% bupivacaine (Sunnypivacaine by Sunny Pharmaceuticals) for each side Group M Intrathecal morphine Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg Group QM Quadratus laborum block 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 QM Intrathecal morphine Intrathecal morphine 100mcg will be added to bupivacaine 0.5% 15mg and fentanyl 20 µg combined by QLB of 30 ml 0.125%bupivacain
- Primary Outcome Measures
Name Time Method Visual analogue scale Six months As zero is no pain and 10 is the maximum pain that can be felt
- Secondary Outcome Measures
Name Time Method narcotic consumption 48 hours narcotic consumption
Trial Locations
- Locations (1)
Menoufia University
🇪🇬Menoufia, Egypt