Ketamine Added to Quadratus Lumborum Block for Pain Relief After Infant Pyeloplasty

NCT07596810 | Completed Phase 4

• 1 other identifier: 0307848
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized study evaluates the effect of adding ketamine to bupivacaine in ultrasound-guided quadratus lumborum (QL) block for postoperative pain management in infants undergoing open pyeloplasty. Forty infants aged 0-12 months undergoing elective open pyeloplasty are randomly assigned to receive either QL block with bupivacaine plus ketamine or QL block with bupivacaine alone. Postoperative pain is assessed using the CRIES pain scale. Additional outcomes include duration of analgesia, rescue opioid requirements, total opioid consumption, length of hospital stay, and occurrence of complications.

Conditions

Ureteropelvic Junction Obstruction; Postoperative Pain

Keywords

Ketamine; Quadratus Lumborum Block QL Block; Ultrasound-Guided Regional Anesthesia; Bupivacaine; Open Pyeloplasty

Outcome Measures

Primary Outcomes (1)

• Postoperative Pain Assessed by CRIES Pain Scale by the end of 24 hours after surgery

  Postoperative pain severity assessed using the CRIES pain scale during the first 24 hours after surgery. Higher scores indicate greater pain severity.

  24 hours after surgery

Secondary Outcomes (4)

• Time to First Rescue Opioid Administration

  24 hours after surgery

• Total Postoperative Opioid Consumption

  24 hours after surgery

• Length of Hospital Stay

  Until hospital discharge (approximately 1-3 days)

• Occurrence of Postoperative Complications

  24 hours after surgery until discharge

Study Arms (2)

Ketamine + Bupivacaine QL Block

EXPERIMENTAL

Participants receive ultrasound-guided quadratus lumborum block using ketamine hydrochloride (1 mg/kg) combined with bupivacaine 0.25% (0.5 mL/kg) during open pyeloplasty.

Drug: Ketamine + Bupivacaine

Bupivacaine QL Block

ACTIVE COMPARATOR

Participants receive ultrasound-guided quadratus lumborum block using bupivacaine 0.25% (0.5 mL/kg) alone during open pyeloplasty.

Drug: Bupivacaine

Interventions

Ketamine + Bupivacaine DRUG

Ketamine hydrochloride (1 mg/kg) added to bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.

Ketamine + Bupivacaine QL Block

Bupivacaine DRUG

Bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.

Bupivacaine QL Block

Eligibility Criteria

• Age: Up to 12 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Infants aged 0 to 12 months
• Scheduled for elective open pyeloplasty
• Eligible for ultrasound-guided quadratus lumborum block
• Parent or legal guardian able to provide informed consent

You may not qualify if:

• Congenital heart disease
• Prematurity
• Mechanical ventilation dependence
• Contraindications to regional anesthesia
• Coagulopathy or bleeding disorders
• Local infection at the injection site
• Known allergy or hypersensitivity to ketamine, bupivacaine, or study medications

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University

Alexandria, Egypt

Location

MeSH Terms

Conditions

Multicystic renal dysplasia, bilateral; Pain, Postoperative

Interventions

Ketamine; Bupivacaine

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Medication solutions were prepared by an independent anesthetist not involved in patient care or data collection. The anesthetist performing the block, surgical and nursing staff, and outcome assessors were blinded to group allocation and study medications.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Model Details: Participants are randomly assigned in a parallel design to receive ultrasound-guided quadratus lumborum block with either bupivacaine plus ketamine or bupivacaine alone during open pyeloplasty.

Study Record Dates

• First Submitted: May 13, 2026
• First Posted: May 19, 2026
• Study Start: June 1, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Locations

EG (1)