An interventional study of Quadratus Lumborum Block and Continuous Epidural in Renal Transplant Donor of Left Kidney, sponsored by Indonesia University. Completed at 1 site in Indonesia. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-10-22.
Sponsored by Indonesia University · Not applicable, Interventional, and Supportive care
This study aimed to compare Quadratus Lumborum Block to Epidural on Stress Response and Perioperative Cellular Immunological Function of Laparoscopic Nephrectomy Kidney Donor
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.
Indonesia University is the lead sponsor of 448 studies on the registry; 56 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Have contraindication for quadratus lumborum block
Patient will receive quadratus lumborum block
Procedure: Quadratus Lumborum Block
Patient will receive epidural anesthesia
Procedure: Continuous Epidural
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
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.
Change from Baseline Interleukin-6 at 24 hours after abdominal insufflation
Measure by ELISA
Time frame: 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
Time frame: 2 hours, 6 hours, 12 hours, 24 hours.
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Intraoperative and 24 hours
Change from Baseline hs-CRP at 48 hours after abdominal insufflation
Measured with ELISA
Time frame: 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
Time frame: 24 hours
Total bupivacaine used in 24 hours
Total bupivacaine used until 24 hours postoperatively
Time frame: 24 hours
Change from baseline motor block at 2, 6, 12, and 24 hours after anesthesia recovery
Measured by Bromage score
Time frame: 2, 6, 12, and 24 hours after procedure
Number of participants with paresthesia after procedure
in percentage
Time frame: 24 hours
Duration of urinary catheter
in hours
Time frame: 24 hours
Level of sensory block after procedure
Measured by cold and pin prick sensation
Time frame: 24 hours
Plan to share: Undecided
This study is completed, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.
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Indonesia University