Comparison of Quadratus Lumborum Block and Epidural Analgesia Following Kidney Transplant Surgery

Study Overview
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Brief Summary
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Quadratus lumborum block as an alternative for postoperative analgesia compared with epidural block

Detailed Description
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Epidural analgesia is the main choice of analgesia following kidney transplant surgery. However, continuous epidural technique had some concerning side effects such as hemodynamic instabilities, urine retention, motor/sensory disturbances/weakness, and mobilisation comfort, it could also cause hypotension which could affect graft success. Quadratus lumborum (QL) block had lesser side effects thus could be an option for postoperative analgesia, however there are no study showing the safety and success rate of QL block techniques for patients who underwent kidney transplant surgery.

Official Title
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Comparison of Ultrasound-Guided Quadratus Lumborum Block and Epidural Analgesia for Postoperative Pain Management After Renal Transplantation

Conditions
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Postoperative Pain

Intervention / Treatment
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* Procedure: Continuous Epidural analgesia
* Procedure: Bilateral Quadratus Lumborum block


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing elective kidney transplant laparotomy surgery Agrees to participate in research BMI < 30 kg/m2 Exclusion Criteria: Declines to participate in research Contraindications to intervention procedures (epidural or quadratus lumborum block) History of local anaesthetic allergy Systemic allergic reactions, anaphylactic reaction, cardiac arrest Failure of intervention procedures (epidural or quadratus lumborum block) Intraoperative complications (massive bleeding, hypotension)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

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
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Epidural Analgesia<br>Continuous epidural analgesia using ropivacaine 0.375% 3 mL boluses followed by ropivacaine 0.2% with rate 6 mL per hour for 24 hours | Procedure: Continuous Epidural analgesia<br>* Continuous Epidural catheter is inserted at the Thoracic 11-T12 level, using Ropivacaine 0.375% 3 mL bolus followed by Ropivacaine 0.2% with rate 6 mL/hour for 24 hours after laparoscopic nephrectomy<br>|
| Experimental: Bilateral Quadratus Lumborum Block<br>Bilateral Quadratus lumborum block using ropivacaine 0.2% 20 mL each injection after surgery | Procedure: Bilateral Quadratus Lumborum block<br>* Bilateral anterior Quadratus Lumborum block using Ropivacaine 0.375% 20 mL each injection as postoperative analgesia treatment for 24 hours<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Additional analgesia required at 2, 6, 12, and 24 hours after surgery | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity | Pain intensity measured using the Visual Analogue Scale (VAS) at 2, 6, 12, and 24 hours after surgery. VAS assessed with horizontal line 0-100 mm for no pain to the worst pain, with range 0-30 mm for none to mild pain, 31-70 mm for moderate pain, 71-100 mm for severe pain. | 24 hours | 
| First time morphine required | Total time gap from postoperative analgesia procedure administration to first morphine requirement | 24 hours | 
| Total minimum and maximum dose of vasoactive agents | Minimum and maximum dose of norepinephrine and dobutamine as vasoactive agents within 24 hours after surgery | 24 hours | 
| Urine output | Urine output (mL/kgBW/hour) after surgery | 24 hours | 
| Bromage score | Bromage score at 2, 6, 12, and 24 hours after surgery to assess lower limb motoric block. Score for Bromage: free movement partial block almost complete complete block | 24 hours | 
| Ramsay score | Ramsay score at 2, 6, 12, and 24 hours after surgery to assess patient sedation level. | 24 hours | 
| Dermatomal coverage of analgesia procedure | dermatome sensory block distribution using cold sensation test | Immediately after anaesthesia completion | 
| Blood ropivacaine level | Arterial blood sample of all subjects will be withdrawn approximately 3 mL from the arterial line at 0, 30, 45, 60 minute, and 2, 4, 6,12,18, 24 hours after designated analgesia procedure, and will be used for ropivacaine blood level measurements using High-Performance Liquid Chromatography (HPLC), to measure Total plasma ropivacaine concentration (Cstop), maximum plasma concentration (Cmax), time of maximum plasma concentration, area under the curve (AUC) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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quadratus lumborum block, continuous epidural, postoperative analgesia, kidney transplant