Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

Study Overview
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Brief Summary
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This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

Detailed Description
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Sixty-two subjects were given informed consent before enrolling the study and randomized into two groups; quadratus lumborum block and epidural. Non-invasive blood pressure monitor, electrocardiogram (ECG), and pulse-oxymetry were set on the subjects in the operation room. General anesthesia induction was done by fentanyl 2 mcg/kg and propofol 1-2 mg/kg. Endotracheal tube (ETT) intubation was facilitated with Atracurium 0.5mg/kg as muscle relaxant. Maintenance was done by sevoflurane, oxygen, and compressed air. On quadratus lumborum block group, bilateral block using ultrasound will be performed with stimuplex 100mm needle with 20 cc of bupivacaine 0.25% as regimen. On epidural group, epidural catheter was inserted under general anaesthesia on left lateral decubitus position (5 cm depth inside the epidural space) at level Th10-Th11. The catheter insertion was confirmed with vacuum aspiration and negative test-dose. Before first incision, patient will be given continuous epidural Bupivacaine 0.25% 6 mL/hour. Blood sample was drawn for interleukin-6, blood glucose, and c-reactive protein as baseline data. After surgery, patient were extubated until fully conscious and can follow command verbally. Patient will be transported in recovery room post operation.

Official Title
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Comparison Between Quadratus Lumborum Block and Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor

Conditions
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Renal Transplant Donor of Left Kidney

Intervention / Treatment
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* Procedure: Quadratus Lumborum Block
* Procedure: Continuous Epidural


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Kidney donor patients undergoing laparoscopic nephrectomy Body mass index below 30 Duration of surgery 4 to 6 hours Patients who agreed to participate in this study and sign informed consent. Exclusion Criteria: Have contraindication for quadratus lumborum block Have contraindication for epidural Previous history of local anesthetic drug allergy inability to communicate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Quadratus Lumborum Block<br>Patient will receive quadratus lumborum block | Procedure: Quadratus Lumborum Block<br>* Bilateral block using ultrasound will be performed before surgery and after surgery on patient using Stimuplex 100mm needle with Bupivacaine 0.25% 0.4 mL/kg, maximum dose 25 mL each side under general anaesthesia<br>|
| Active Comparator: Continuous Epidural<br>Patient will receive epidural anesthesia | Procedure: Continuous Epidural<br>* Patient will be given 6 mL/hour of Bupivacaine 0.25% for intraoperative analgesia and continued epidural 6 mL/hour Bupivacaine 0,125% as postoperative analgesia in 24 hours.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation | Measure by ELISA | Before procedure, at the end of surgery, and 24 hours after abdominal insufflation | 
| Cumulative morphine requirement at 2 hours, 6 hours, 12 hours, 24 hours postoperative | Cumulative morphine consumption at each time point in 24 hours after surgery | 2 hours, 6 hours, 12 hours, 24 hours. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Patient Controlled Analgesia at 2, 6, 12 and 24 hours after procedure | Measure by how many times patient use morphine PCA analgesia | 2, 6, 12, and 24 hours after procedure | 
| Change from Baseline Pain Intensity at 2, 6, 12, and 24 hours after procedure | Measured by Numerical Rating Scale | 2, 6, 12, and 24 hours after procedure | 
| Change from Baseline Blood Glucose at 2 hours after abdominal insufflation | Measured by finger-stick blood sample | Before procedure and 2 hours after abdominal insufflation | 
| Change from Baseline Blood pressure | Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery | Intraoperative and 24 hours | 
| Change from Baseline Mean Arterial Pressure | Measured by non-invasive blood pressure monitoring at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery | Intraoperative and 24 hours | 
| Change from Baseline Cardiac Index | Measured by cardiometry ICON® at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery | Intraoperative and 24 hours | 
| Change from Baseline Heart Rate | Measured by pulse oximetry at before anaesthesia induction (baseline), post-induction, gas-insufflation, Pfannenstiel incision, end of surgery, and 24 hours surgery | Intraoperative and 24 hours | 
| Change from Baseline hs-CRP at 48 hours after abdominal insufflation | Measured with ELISA | Before procedure, at the end of surgery, and 48 hours after abdominal insufflation | 
| Time to first morphine requirement | Duration from end of anesthesia until first attempt of morphine requirement in minutes | 24 hours | 
| Total bupivacaine used in 24 hours | Total bupivacaine used until 24 hours postoperatively | 24 hours | 
| Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery | Measured by Bromage score | 2, 6, 12, and 24 hours after procedure | 
| Number of participants with paresthesia after procedure | in percentage | 24 hours | 
| Duration of urinary catheter | in hours | 24 hours | 
| Level of sensory block after procedure | Measured by cold and pin prick sensation | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stress response, kidney donor, Cellular Imunological Function, quadratus lumborum block, numerical rating scale, morphine patient controlled analgesia