Erector Spinae Plane Block in Pediatric Lower Limb Surgery

NCT05369455 | Completed DMC

• 1 other identifier: 35040/11/21
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

Anesthesia will be induced in all patients using Fentanyl 1µg,propofol 2mg/kg and cisatracurium 0.15 mg/kg IV to facilitate endotracheal intubation, maintenance of anaesthesia afterward will be achieved by isoflurane1.5-2% in oxygen and air mixture, cisatracurium0.03 mg/kg. In both groups , ultrasound guided block will be performed by an experienced anesthesiologist who has no subsequent role in the study after induction of anesthesia and before starting of surgery in lateral position, sterilized and covered with sterile sheets. Aseptic precautions is taken by wearing sterile gowns and gloves A sterile preparation of the ultrasound probe is obligatory. Outcome parameters will be assessed by another anesthesiologist blinded to the groups of assignment. Group 1: group of ultrasound guided Erector spine plane block: Group 11: group of ultrasound guided Cauda block:

Conditions

Efficacy of Erector Spinae Plane Block in Lower Limb Surgery in Pediatric

Keywords

erector spinae -block-pediatric -lower limb

Outcome Measures

Primary Outcomes (1)

• pain score

  pain will be assessed using Face, Legs, Activity, Cry, and Consolability (FLACC) or Numeric Rating Scale (NRS) scores

  in first 24 hours postoperatively

Secondary Outcomes (1)

• total postoperative analgesic requirement

  first 24 hours postoperatively

Study Arms (2)

group 1

EXPERIMENTAL

group of ultrasound guided Erector spine plane block:

Procedure: erector spinae plane block

group 2

ACTIVE COMPARATOR

group of ultrasound guided Caudal block:

Procedure: ultrasound guided caudal block

Interventions

erector spinae plane block PROCEDURE

determine the efficacy and safety of ultra-sound guided erector spine plane block for providing postoperative analgesia in pediatric patients scheduled for lower limb surgeries as regard pain score , duration of analgesia and total postoperative analgesic requirement as a primary outcome as well as their safety as regard hemodynamics, adverse events local complications as secondary outcomes.

group 1

ultrasound guided caudal block PROCEDURE

determine the efficacy and safety of ultra-sound guided caudal block for providing postoperative analgesia in pediatric patients scheduled for lower limb surgeries as regard pain score , duration of analgesia and total postoperative analgesic requirement as a primary outcome as well as their safety as regard hemodynamics, adverse events local complications as secondary outcomes.

group 2

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• aged 2-15years old,
• classified by the American society of anesthesiologists as ASA I and II
• who will be scheduled for elective lower limb surgery will be enrolled in our study.

You may not qualify if:

• Parents refusal,
• spine or chest wall deformity,
• coagulation disorders, ,
• known respiratory and cardiac disorders, renal or hepatic insufficiency
• known allergy to study drugs, uncooperative patients.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, 31511, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: neither investigator nor outcome assessors know which block patient had received
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: principle investigator

Study Record Dates

• First Submitted: April 23, 2022
• First Posted: May 11, 2022
• Study Start: December 9, 2021
• Primary Completion: May 10, 2022
• Study Completion: July 30, 2022
• Last Updated: October 19, 2022

Record last verified: 2022-10

Locations

EG (1)