Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

Not Applicable

Completed

• Conditions: Renal Transplant Donor of Left Kidney
• Interventions: Procedure: Quadratus Lumborum Block; Procedure: Continuous Epidural

• Registration Number: NCT03520205
• Lead Sponsor: Indonesia University

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-04-15
• Study First Submitted QC: 2018-04-26
• Study Start: 2018-05-01
• Study First Posted: 2018-05-09
• Primary Completion: 2018-10-30
• Study Completion: 2018-12-31
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-21
• Last Update Posted: 2019-10-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Quadratus Lumborum Block	Quadratus Lumborum Block	Patient will receive quadratus lumborum block
Continuous Epidural	Continuous Epidural	Patient will receive epidural anesthesia

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Cipto Mangunkusumo Central National Hospital; 🇮🇩 Jakarta Pusat, DKI Jakarta, Indonesia