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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Bupivacaine QL Block | Active Comparator | Participants receive ultrasound-guided quadratus lumborum block using bupivacaine 0.25% (0.5 mL/kg) alone during open pyeloplasty. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time to First Rescue Opioid Administration | Time elapsed from completion of surgery to first administration of rescue opioid analgesia (intravenous fentanyl). | 24 hours after surgery |
| Total Postoperative Opioid Consumption |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alexandria University | Alexandria | Egypt |
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| ID | Term |
|---|---|
| C537373 | Multicystic renal dysplasia, bilateral |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007649 | Ketamine |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
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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.
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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.
| Bupivacaine | Drug | Bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty. |
|
Total postoperative fentanyl consumption during the postoperative observation period.
| 24 hours after surgery |
| Length of Hospital Stay | Duration of hospitalization measured in days following surgery. | Until hospital discharge (approximately 1-3 days) |
| Occurrence of Postoperative Complications | Incidence of adverse events and complications related to the intervention or postoperative period. | 24 hours after surgery until discharge |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D000588 | Amines |