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Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries.

Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries, a Randomized Clinical Trial.

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04790318
Enrollment
40
Registered
2021-03-10
Start date
2021-03-15
Completion date
2022-10-20
Last updated
2022-12-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia

Brief summary

There is scare literature about the usage of QLB in pediatric population, particularly the trans-incisional approach. Hence, the purpose of this study is to compare the postoperative analgesic efficacy of ultrasound-guided caudal epidural block versus ultrasound-guided QLB (trans-incisional) in combination with general anesthesia in pediatric patients undergoing elective open renal surgeries regarding pain scores, total analgesic consumption, and adverse effects.

Interventions

PROCEDURETrans-incisional Quadratus lumborum block

patients will receive combined general anesthesia and quadratus lumborum block (trans-incisional) with 0.5 mL/kg of bupivacaine 0.2 %. with maximum volume was limited to 20 ml

PROCEDURECaudal block

patients will receive combined general anesthesia and caudal analgesia (just after wound closure) with 1.25 mL/kg of bupivacaine 0.2 % (three parts 0.25 % bupivacaine to one part saline.

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
2 Years to 11 Years
Healthy volunteers
No

Inclusion criteria

1. patients who will be scheduled for indicated open pediatric renal surgery in the lateral decubitus position (nephrectomy, partial nephrectomy, pyeloplasty and nephrolithotomy for complex renal stones). 2. physical status American Society of Anesthesiologists (ASA) I or II.

Exclusion criteria

1. \- patients whose guardians refuse to participate. 2. -ASA physical status \>II. 3-patients who have contraindications to regional analgesic procedures. 4-patients who have major illnesses (e.g., cardiac, respiratory, renal, hepatic or neurological). 5-spine or chest wall deformity. 6-History of previous renal surgeries. 7-Coagulation abnormalities. 8-Infection at the injection site. 9-An allergy or contraindications to the drugs used in the study.

Design outcomes

Primary

MeasureTime frameDescription
First time to analgesic requirement1st 24 hourKetorolac is an IV NSAID that has been shown to have similar efficacy to morphine . Ketorolac will be dosed at 0.5 mg/kg every 6-8 hours for the 1st 24 h postoperatively as an analgesic after request.

Secondary

MeasureTime frameDescription
total analgesic consumption1st 24 hourKetorolac will be dosed at 0.5 mg/kg every 6-8 hours for the 1st 24 h postoperatively as an analgesic after request.Total ketorolac consumption per 24 h will be calculated .
Face, leg, activity, cry, consolability scale (FLACC)1st 24 hours postoperativelyPain scores will be evaluated by a blinded observer anesthesiologist at the time of arrival in the PACU and 10, 20, and 30 min and 1, 2, 4, 6, 12, and 24 h thereafter using the face, leg, activity, cry, consolability scale (FLACC) (ranging from 0-10, where 0 = no pain, 10 = worst pain).

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026