Ketamine Added to Quadratus Lumborum Block for Pain Relief After Infant Pyeloplasty (KETA-QLB)

May 13, 2026 updated by: ahmed ragab, Alexandria University

Ketamine As Adjuvant to Bupivacaine in Ultrasound Guided Quadratus Lumborum Block for Infants Undergoing Open Pyeloplasty

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postoperative pain management in infants undergoing open pyeloplasty remains challenging because opioid use may be associated with adverse effects, including respiratory depression, nausea, vomiting, and delayed recovery. Regional anesthesia techniques, including ultrasound-guided quadratus lumborum (QL) block, may improve postoperative analgesia and reduce opioid requirements.

Ketamine has analgesic properties through N-methyl-D-aspartate (NMDA) receptor antagonism and has been investigated as an adjuvant to local anesthetics in regional anesthesia. However, evidence regarding its use as an adjuvant in ultrasound-guided QL block in infants undergoing pyeloplasty is limited.

This prospective randomized study aims to evaluate the effectiveness of adding ketamine to bupivacaine in ultrasound-guided QL block for infants undergoing open pyeloplasty. Forty infants aged 0-12 months scheduled for elective open pyeloplasty are randomized into two groups. One group receives ultrasound-guided QL block using bupivacaine 0.25% (0.5 mL/kg) combined with ketamine hydrochloride (1 mg/kg), while the control group receives bupivacaine 0.25% (0.5 mL/kg) alone.

The primary outcome measure is postoperative pain assessed using the CRIES pain scale during the first 24 hours after surgery. Secondary outcome measures include time to first rescue opioid administration, total postoperative opioid consumption, length of hospital stay, and occurrence of adverse events or complications.

This study seeks to determine whether ketamine may improve postoperative analgesia and reduce opioid requirements when used as an adjuvant to bupivacaine in pediatric regional anesthesia.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ketamine + Bupivacaine QL Block
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
Ketamine hydrochloride (1 mg/kg) added to bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.
Active Comparator: Bupivacaine QL Block
Participants receive ultrasound-guided quadratus lumborum block using bupivacaine 0.25% (0.5 mL/kg) alone during open pyeloplasty.
Drug: Bupivacaine
Bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative Pain Assessed by CRIES Pain Scale by the end of 24 hours after surgery
Time Frame: 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to First Rescue Opioid Administration
Time Frame: 24 hours after surgery
Time elapsed from completion of surgery to first administration of rescue opioid analgesia (intravenous fentanyl).
24 hours after surgery
Total Postoperative Opioid Consumption
Time Frame: 24 hours after surgery
Total postoperative fentanyl consumption during the postoperative observation period.
24 hours after surgery
Length of Hospital Stay
Time Frame: Until hospital discharge (approximately 1-3 days)
Duration of hospitalization measured in days following surgery.
Until hospital discharge (approximately 1-3 days)
Occurrence of Postoperative Complications
Time Frame: 24 hours after surgery until discharge
Incidence of adverse events and complications related to the intervention or postoperative period.
24 hours after surgery until discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2025

Primary Completion (Actual)

January 1, 2026

Study Completion (Actual)

February 1, 2026

Study Registration Dates

First Submitted

May 13, 2026

First Submitted That Met QC Criteria

May 13, 2026

First Posted (Actual)

May 19, 2026

Study Record Updates

Last Update Posted (Actual)

May 19, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0307848

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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