Comparison of Spinal Anesthesia Adjuvant and Quadratus Lumborum Block on the Opioid Requirement and Perioperative Pain of Laparoscopic Kidney Transplant Donor

This study aims to compare the effectiveness of spinal anesthesia adjuvant and quadratus lumborum block on the opioid requirement and perioperative pain on patients undergoing laparoscopic kidney transplant donor.

Study Overview

• Status: Recruiting
• Conditions: Laparoscopic Donor Nephrectomy; Perioperative Pain Management
• Intervention / Treatment: Procedure: Quadratus Lumborum Block (QLB); Procedure: General Anesthesia; Procedure: Spinal anesthesia adjuvant

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dita Aditianingsih, Prof.; Phone Number: +628151819244; Email: ditaaditiaa@gmail.com

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Recruiting
      • RSUP dr. Cipto Mangunkusumo
      • Contact: Dita Aditianingsih, Prof.; Phone Number: +628151819244; Email: ditaaditiaa@gmail.com
      • Contact: Email: ditaaditiaa@gmail.com
      • Contact: Alfan Mahdi Nugroho, dr.
      • Contact: Dita Aditianingsih, Prof.
      • Contact: Muncieto Andreas, dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients aged 18-65 years undergoing laparoscopic donor nephrectomy
• Patients with BMI ≤ 35 kg/m2
• Patients with American Society of Anesthesiology (ASA) physical status 1-2
• Patients who are willing to participate in this study

Exclusion Criteria:

• Cardiovascular disease (uncontrolled stage 2 hypertension, heart failure, arrhytmia)
• Recent onset cerebrovascular diseasae of < 3 months
• Infection on spinal site
• Coagulopathy
• Elevated intracranial pressure
• Severe renal or liver dysfunction
• Valvular heart disease or atrioventricular block

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Quadratus lumborum block; Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation.	Procedure: Quadratus Lumborum Block (QLB); Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation.; Procedure: General Anesthesia; The subject will undergo preoxygenation with 100% oxygen for 3 minutes. Following preoxygenation, anesthesia induction will be performed using lidocaine at a dose of 1.5 mg/kg, fentanyl at 1.5 mcg/kg, and propofol at 2.0 mg/kg. Once the subject is adequately sedated, baseline neuromuscular monitoring using the train-of-four (TOF) technique will be conducted, followed by the administration of rocuronium at a dose of 0.8 mg/kg. Endotracheal intubation will be performed using direct laryngoscopy once the TOF value reaches 0, utilizing an appropriately sized endotracheal tube (ETT). Ten milligrams of intravenous dexamethasone is administered after induction.
Experimental: Spinal anesthesia adjuvant; Patients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia.	Procedure: General Anesthesia; The subject will undergo preoxygenation with 100% oxygen for 3 minutes. Following preoxygenation, anesthesia induction will be performed using lidocaine at a dose of 1.5 mg/kg, fentanyl at 1.5 mcg/kg, and propofol at 2.0 mg/kg. Once the subject is adequately sedated, baseline neuromuscular monitoring using the train-of-four (TOF) technique will be conducted, followed by the administration of rocuronium at a dose of 0.8 mg/kg. Endotracheal intubation will be performed using direct laryngoscopy once the TOF value reaches 0, utilizing an appropriately sized endotracheal tube (ETT). Ten milligrams of intravenous dexamethasone is administered after induction.; Procedure: Spinal anesthesia adjuvant; Patients in this arm will receive 10 mg 0.5% hyperbaric Bupivacaine, 100 mcg Morphine, 100 mcg Sulfas Atropine, and 0.9% normal saline to total volume of 4 ml before induction of anesthesia.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain	Postoperative pain measured with Numerical Rating Scale (NRS) during rest and movement.	Hour 2, 6, 12, and 24
Opioid requirement	Morphine requirement on Patient-Controlled Analgesia (PCA).	Hour 2, 6, 12, and 24

Collaborators and Investigators

• Sponsor: Indonesia University
• Collaborators: Cipto Mangunkusumo Hospital, Jakarta, Indonesia

Study record dates

Study Major Dates

• Study Start (Actual): February 10, 2025
• Primary Completion (Estimated): November 30, 2025
• Study Completion (Estimated): January 31, 2026

Study Registration Dates

• First Submitted: January 2, 2025
• First Submitted That Met QC Criteria: January 2, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 1, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: Perioperative pain management; Quadratus lumborum block; Laparoscopic donor nephrectomy; Spinal anesthesia adjuvant
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Anesthetics; Adjuvants, Anesthesia
• Other Study ID Numbers: IndonesiaUAnes048

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No