Ureteropelvic Junction ObstructionPhase 4KETA-QLBNCT07596810
Ketamine Added to Quadratus Lumborum Block for Pain Relief After Infant Pyeloplasty
A Phase 4 study testing Ketamine + Bupivacaine and Bupivacaine in people with Ureteropelvic Junction Obstruction and Postoperative Pain, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 12 months
- Conditions the study is for
- Ureteropelvic Junction Obstruction, Postoperative Pain
- What is being tested?
- Ketamine + Bupivacaine and Bupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Feb 2026
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 12 months
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Ketamine + Bupivacaine, Bupivacaine
- Keywords
- Ketamine, Quadratus Lumborum Block QL Block, Ultrasound-Guided Regional Anesthesia, Bupivacaine, Open Pyeloplasty
- Medical subject headings
- Multicystic renal dysplasia, bilateral, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine + BupivacaineDrug
Ketamine hydrochloride (1 mg/kg) added to bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.
BupivacaineDrug
Bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 hours after surgery
Secondary outcomes (4)
Time to First Rescue Opioid Administration
Time elapsed from completion of surgery to first administration of rescue opioid analgesia (intravenous fentanyl).
Measured: 24 hours after surgery
Total Postoperative Opioid Consumption
Total postoperative fentanyl consumption during the postoperative observation period.
Measured: 24 hours after surgery
Length of Hospital Stay
Duration of hospitalization measured in days following surgery.
Measured: Until hospital discharge (approximately 1-3 days)
Occurrence of Postoperative Complications
Incidence of adverse events and complications related to the intervention or postoperative period.
Measured: 24 hours after surgery until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2026
- Study start1 Jun 2025
- Primary completion1 Jan 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteropelvic Junction ObstructionStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ahmed ragab, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07596810
- Sponsor's protocol ID
- 0307848
- Acronym
- KETA-QLB
- Status last verified
- May 2026
- First submitted
- 13 May 2026
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ketamine As Adjuvant to Bupivacaine in Ultrasound Guided Quadratus Lumborum Block for Infants Undergoing Open Pyeloplasty
- ClinicalTrials.gov ID
- NCT07596810
- Acronym / sponsor ID
- KETA-QLB / 0307848
- Keywords
- Ketamine, Quadratus Lumborum Block QL Block, Ultrasound-Guided Regional Anesthesia, Bupivacaine, Open Pyeloplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jan 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 19 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Ketamine + Bupivacaine QL Block | Experimental | Drug: Ketamine + BupivacaineParticipants 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 | Drug: BupivacaineParticipants receive ultrasound-guided quadratus lumborum block using bupivacaine 0.25% (0.5 mL/kg) alone during open pyeloplasty. |
Who may qualify
- Ages
- Up to 12 months
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- Congenital heart disease
- Prematurity
- Mechanical ventilation dependence
- Contraindications to regional anesthesia
- Coagulopathy or bleeding disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ketamine + BupivacaineKetamine hydrochloride (1 mg/kg) added to bupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty. | Drug | Ketamine + Bupivacaine QL Block |
| BupivacaineBupivacaine 0.25% (0.5 mL/kg) administered by ultrasound-guided quadratus lumborum block during open pyeloplasty. | Drug | Bupivacaine QL Block |
Primary outcome
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.
4 secondary outcomes
Time to First Rescue Opioid Administration
Time frame: 24 hours after surgery
Total Postoperative Opioid Consumption
Time frame: 24 hours after surgery
Length of Hospital Stay
Time frame: Until hospital discharge (approximately 1-3 days)
Occurrence of Postoperative Complications
Time frame: 24 hours after surgery until discharge
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2026.
Related trials for Ureteropelvic Junction Obstruction
Not yet recruitingPhase 4
Effect of Oxybutynin on Opioid Use After Urologic Surgery in Children
Ureteropelvic Junction Obstruction, Hypospadias
RecruitingObservational study
Renal SWE as a Predictor After Pediatric Pyeloplasty for UPJO
Ureteropelvic Junction Obstruction, Renal Functional Recovery
RecruitingObservational study
Ultrasound Localization Microscopy in Patient With Congenital Anomalies of the Kidney and Urinary Tract (CAKUT)
Congenital Anomalies of Kidney and Urinary Tract, Lower Urinary Tract Obstruction, Congenital
Active, not recruiting
Different Surgical Modalities in the Management of Pelvi-ureteric Junction Obstruction
Pelvi-ureteric Junction Obstruction
RecruitingObservational study
The PRO-FUTURE Project
Ureteropelvic Junction Obstruction, Chronic Kidney Diseases
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ketamine + Bupivacaine and Bupivacaine in people with Ureteropelvic Junction Obstruction and Postoperative Pain, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Assessed by CRIES Pain Scale by the end of 24 hours after surgery (time frame: 24 hours after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2026.