Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients

Post Operative Pain Clinical Trial

Official title:

Ultrasound-Guided Lumbar Erector Spinae Plane Block Versus Caudal Block for Postoperative Analgesia in Hip and Proximal Femur Surgery in Pediatric Patients: A Prospective Randomized Controlled Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05157516
• Other study ID #: MD-340-2020
• Status: Completed
• Phase: Phase 3
• Start date: December 21, 2021
• Est. completion date: June 28, 2022

Study information

• Verified date: July 2022
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will compare Ultrasound-Guided Lumbar Erector Spinae Plane Block and caudal block for Postoperative Analgesia in Hip and Proximal Femur Surgery in pediatric patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: June 28, 2022
• Est. primary completion date: June 2, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 7 Years

Eligibility

Inclusion Criteria:

• ASA I-II.

• Scheduled to undergo hip or proximal femur surgeries.

Exclusion Criteria:

• Refusal of participation by parents or caregivers

• Known local anesthetic (LA) drug sensitivity

• Bleeding disorders with INR > 1.5 and/or platelets < 100,000/mm3.

• Skin lesions or wounds at the site of proposed needle insertion.

Related Conditions & MeSH terms

• Pain, Postoperative
• Post Operative Pain

Intervention

Procedure:
• erector spinea block
the patients will receive a single injection erector spinea block after induction of general anesthesia
• Caudal epidural block
the patients will receive caudal epidural block after induction of general anesthesia

Locations

Country	Name	City	State
Egypt	Kasr Alaini hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score	By using face, legs, activity, and cry consolability scale [FLACC ]; FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.; Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain	2 hours post-operatively
Secondary	pain scores	By using face, legs, activity, and cry consolability scale [FLACC ]; FLACC scale will be measured as following: Each category (face,legs,activity, and cry consolability) is scored on the 0-2 scale which results in a total score of 0-10.; Assessment of the final score: 0 = Relaxed and comfortable 1-3 = Mild discomfort 4-6 = Moderate pain 7-10 = Severe discomfort/pain	at 2 hour intervals during the first 24 hours postoperatively
Secondary	Block failure rate	The block will be considered a failed block if the patient required more than two doses of rescue analgesia in the first hour postoperatively	First hour postoperatively
Secondary	Block performance time		Preoperative
Secondary	The incidence of adverse effects		Up to one week after the block
Secondary	Duration of the block		UP to 48 hours postoperatively
Secondary	Degree of contralateral motor blockage and lower limb weakness	By using modified bromage scale as following: Grade I : Free movement of legs and feet Degree of block :Nil (0%); Grade II :Just able to flex knees with free movement of feet Degree of block :Partial (33%); Grade III :Unable to flex knees, but with free movement of feet Degree of block: Almost complete (66%); Grade IV :Unable to move legs or feet Degree of block: Complete (100%)	UP to 48 hours postoperatively