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

NCT04790318 | Completed

• 1 other identifier: FMASU R 48/2020/2021
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

• First time to analgesic requirement

  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.

  1st 24 hour

Secondary Outcomes (2)

• total analgesic consumption

  1st 24 hour

• Face, leg, activity, cry, consolability scale (FLACC)

  1st 24 hours postoperatively

Study Arms (2)

General Anesthesia +TiQLB

ACTIVE COMPARATOR

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

Procedure: Trans-incisional Quadratus lumborum block

General Anesthesia+ Caudal block

ACTIVE COMPARATOR

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.

Procedure: Caudal block

Interventions

Trans-incisional Quadratus lumborum block 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 +TiQLB

Caudal block 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.

General Anesthesia+ Caudal block

Eligibility Criteria

• Age: 2 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).
• physical status American Society of Anesthesiologists (ASA) I or II.

You may not qualify if:

• \- patients whose guardians refuse to participate.
• 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).
• 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.

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain Shams University hospitals

Cairo, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: March 2, 2021
• First Posted: March 10, 2021
• Study Start: March 15, 2021
• Primary Completion: September 15, 2022
• Study Completion: October 20, 2022
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

EG (1)