Quadratus Lumborum Block Versus Epidural for Laparoscopic Nephrectomy Kidney Donor

N/ACompletedNCT03520205

Indonesia University62 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

Conditions

Renal Transplant Donor of Left Kidney

Interventions

Quadratus Lumborum BlockPROCEDURE

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

Continuous EpiduralPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Cipto Mangunkusumo Central National Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Outcomes

Primary Outcomes

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.

Secondary Outcomes

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

Data from ClinicalTrials.gov

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