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

NCT ID: NCT04790318

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-03-15

Study Completion Date

2022-10-20

Brief Summary

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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

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Conditions

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Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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General Anesthesia +TiQLB

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

Group Type ACTIVE_COMPARATOR

Trans-incisional Quadratus lumborum block

Intervention Type PROCEDURE

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

General Anesthesia+ 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.

Group Type ACTIVE_COMPARATOR

Caudal block

Intervention Type PROCEDURE

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.

Interventions

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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 was limited to 20 ml

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

2 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Amin Mohammed Alansary Amin Ahmed Helwa

Assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University hospitals

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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FMASU R 48/2020/2021

Identifier Type: -

Identifier Source: org_study_id