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Completed

NCT Number: NCT07596810

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

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Key information

Conditions

Ureteropelvic Junction Obstruction Multicystic renal dysplasia, bilateral Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Signs and Symptoms

Age range

Up to 12 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Bupivacaine

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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).

  2. Total Postoperative Opioid Consumption

    Time frame: 24 hours after surgery

    Total postoperative fentanyl consumption during the postoperative observation period.

  3. Length of Hospital Stay

    Time frame: Until hospital discharge (approximately 1-3 days)

    Duration of hospitalization measured in days following surgery.

  4. 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.

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: KETA-QLB

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 19, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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