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

Sponsor
Ain Shams University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04790318
Collaborator
(none)
40
1
2
20.1
2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Trans-incisional Quadratus lumborum block
  • Procedure: Caudal block
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Trans-incisional Quadratus Lumborum Block Versus Caudal Analgesia in Pediatric Open Renal Surgeries, a Randomized Clinical Trial.
Actual Study Start Date :
Feb 15, 2021
Anticipated Primary Completion Date :
Sep 15, 2022
Anticipated Study Completion Date :
Oct 20, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: 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

Procedure: 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

Active Comparator: 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.

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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 .

  2. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years to 11 Years
Sexes Eligible for Study:
All
Accepts 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:
    • patients whose guardians refuse to participate.
  1. -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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ain Shams University hospitals Cairo Egypt

Sponsors and Collaborators

  • Ain Shams University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Amin Mohammed Alansary Amin Ahmed Helwa, Assistant professor, Ain Shams University
ClinicalTrials.gov Identifier:
NCT04790318
Other Study ID Numbers:
  • FMASU R 48/2020/2021
First Posted:
Mar 10, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jul 8, 2022