Ketamine As Adjuvant to Bupivacaine in Ultrasound Guided Quadratus Lumborum Block for Infants Undergoing Open Pyeloplasty
Trial Snapshot
- Phase
- Phase 4
- Status
- Completed
- Sponsor
- Alexandria University
- Enrollment
- 40
- Locations
- 1
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- — to 12 Months (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Investigators
ahmed ragab
lecturer
Alexandria University