Conventional Caudal Block, Ultrasound Guided Caudal Block and Ultrasound Guided Erector Spinae Block for Pediatric Hip Surgery

NCT04712370 | Unknown

• 1 other identifier: 33143/05/19
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief Summary

This study will be conducted to compare the efficacy and safety of ultrasound guided erector spinae block , ultrasound guided caudal block and conventional caudal block for pain management after pediatric hip surgery.

Conditions

Conventional Caudal Block; Ultrasound Guided Caudal Block; Ultrasound Guided Erector Spinae Block; Pediatric Hip Surgery

Outcome Measures

Primary Outcomes (1)

• Degree of pain intensity

  To evaluate the pain scores by (FLACC) scale. (FLACC) scale will be assessed after surgery over 24 hours where (0 = Relaxed and comfortable, 1-3 = Mild discomfort, 4-6 = Moderate pain ,7-10 = Severe discomfort /pain)

  First 24 hours postoperative

Secondary Outcomes (7)

• Changes in mean arterial blood pressure

  Intraoperative and first 24 hours postoperative

• Changes in heart rate

  Intraoperative and first 24 hours postoperative

• Amount of Analgesic required in the first day after surgery

  First 24 hours postoperative

• Time to first rescue analgesic demand after surgery.

  First 24 hours postoperative

• Success rate of block

  Intraoperative duration

Study Arms (3)

Conventional caudal block

ACTIVE COMPARATOR

Patients of this group will receive the conventional method (blind technique without ultrasound) of caudal block

Procedure: Conventional caudal block

Ultrasound-guided caudal block

EXPERIMENTAL

Patients of this group will receive caudal block using ultrasound.

Procedure: Ultrasound-guided caudal block

Ultrasound guided erector spinae plane Block

EXPERIMENTAL

Patients of this group will receive ultrasound guided erector spinae plane Block at the level of the transverse process of the second lumbar vertebrae(L2) .

Procedure: Ultrasound guided erector spinae plane Block

Interventions

Conventional caudal block PROCEDURE

Patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space) by the conventional method (blind technique without ultrasound).

Conventional caudal block

Ultrasound-guided caudal block PROCEDURE

Using ultrasound, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected in the caudal epidural space).

Ultrasound-guided caudal block

Ultrasound guided erector spinae plane Block PROCEDURE

Under ultrasound guidance, patients of this group will receive (0.5ml/kg) (plain bupivacaine 0.25% injected beneath the erector spinae muscle sheath) at the level of the transverse process of the second lumbar vertebrae(L2).

Ultrasound guided erector spinae plane Block

Eligibility Criteria

• Age: 4 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Both sex
• ASA physical activity I, II
• Age 4-12 years
• Admitted for elective hip surgery.

You may not qualify if:

• Parents refusal
• Children with severe systemic disease
• ASA III or IV
• Children with previous neurological or spinal anomaly, coagulation disorders
• History of premature birth
• Infection at the block injection site
• History of allergy to local anesthetics
• Bilateral hip surgery.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University Hospitals

Tanta, ElGharbiaa, 31527, Egypt

RECRUITING

Central Study Contacts

Eman Hamdy Abu-Shanab, MSc

CONTACT

+201005518097; eman.hamdy@med.tanta.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Assistant lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 15, 2021
• Study Start: January 16, 2021
• Primary Completion: September 1, 2021
• Study Completion: September 10, 2021
• Last Updated: January 20, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For 1 year after the end of the study
• Access Criteria: The principal investigator will review requests

Locations

EG (1)