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

Not Applicable

Completed

• Conditions: Anesthesia
• Interventions: Procedure: Trans-incisional Quadratus lumborum block; Procedure: Caudal block

• Registration Number: NCT04790318
• Lead Sponsor: Ain Shams University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-02
• Study First Submitted QC: 2021-03-05
• Study First Posted: 2021-03-10
• Study Start: 2021-03-15
• Primary Completion: 2022-09-15
• Study Completion: 2022-10-20
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-20
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anesthesia +TiQLB	Trans-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 limited to 20 ml
General Anesthesia+ Caudal block	Caudal 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.

Primary Outcome Measures

Name	Time	Method
First time to analgesic requirement	1st 24 hour	Ketorolac 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 Outcome Measures

Name	Time	Method
Face, leg, activity, cry, consolability scale (FLACC)	1st 24 hours postoperatively	Pain 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).
total analgesic consumption	1st 24 hour	Ketorolac 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 .

Trial Locations

Locations (1)

Ain Shams University hospitals; 🇪🇬 Cairo, Egypt