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

NCT ID: NCT06764667

Last Updated: 2025-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-10

Study Completion Date

2026-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Donor Nephrectomy Perioperative Pain Management

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Quadratus Lumborum Block (QLB)

Intervention Type 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.

General Anesthesia

Intervention Type 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.

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.

Group Type EXPERIMENTAL

Spinal anesthesia adjuvant

Intervention Type 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.

General Anesthesia

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role collaborator

Indonesia University

OTHER

Sponsor Role lead

Responsible Party

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Dita Aditianingsih

Prof. Dr. dr. Dita Aditianingsih, Sp.An-TI., Subsp.T.I.(K).

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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RSUP dr. Cipto Mangunkusumo

Jakarta Pusat, Jakarta Special Capital Region, Indonesia

Site Status RECRUITING

Countries

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Indonesia

Central Contacts

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Dita Aditianingsih, Prof.

Role: CONTACT

+628151819244

Facility Contacts

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Dita Aditianingsih, Prof.

Role: primary

+628151819244

Role: backup

Other Identifiers

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IndonesiaUAnes048

Identifier Type: -

Identifier Source: org_study_id

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