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

NCT06764667 | Recruiting

• 1 other identifier: IndonesiaUAnes048
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Laparoscopic Donor Nephrectomy; Perioperative Pain Management

Keywords

Quadratus lumborum block; Spinal anesthesia adjuvant; Laparoscopic donor nephrectomy; Perioperative pain management

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Quadratus lumborum block

ACTIVE COMPARATOR

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); Procedure: General Anesthesia

Spinal anesthesia adjuvant

EXPERIMENTAL

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: Spinal anesthesia adjuvant; Procedure: General Anesthesia

Interventions

Spinal anesthesia adjuvant PROCEDURE

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.

Spinal anesthesia adjuvant

Quadratus Lumborum Block (QLB) PROCEDURE

Patients in this arm will receive quadratus lumborum block with 20-30 ml of 0.25% Bupivacaine after induction of anesthesia and after operation.

Quadratus lumborum block

General Anesthesia PROCEDURE

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.

Quadratus lumborum block; Spinal anesthesia adjuvant

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indonesia University: lead
• Dr Cipto Mangunkusumo General Hospital: collaborator

Study Sites (1)

RSUP dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, 10430, Indonesia

RECRUITING

MeSH Terms

Interventions

Anesthesia, General

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia

Central Study Contacts

Dita Aditianingsih, Prof.

CONTACT

+628151819244; ditaaditiaa@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. dr. Dita Aditianingsih, Sp.An-TI., Subsp.T.I.(K).

Study Record Dates

• First Submitted: January 2, 2025
• First Posted: January 8, 2025
• Study Start: February 10, 2025
• Primary Completion: November 30, 2025
• Study Completion: January 31, 2026
• Last Updated: March 4, 2025

Record last verified: 2025-03

Locations

ID (1)