Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

Orthopedic Disorder Clinical Trial

Official title:

Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks for Pain Management After Orthopedic Surgical Procedures Involving Hip and Femur in Pediatrics.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03746951
• Other study ID #: IRB18-01102
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: April 24, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: February 2022
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The investigators aim to compare the use of a suprainguinal fascia iliaca compartment block vs lumbar plexus block as an adjunct to general anesthesia in pediatric patients undergoing orthopedic procedures involving the hip or upper femur. This study will help determine the efficacy of the two techniques and their advantages when compared to each other including time to perform the block, opioid consumption reduction, effects on postoperative pain, and the length of stay.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 18 Years

Eligibility

Inclusion Criteria:

• ASA grade I-III
• Undergoing elective orthopedic surgical procedures involving the hip and upper thigh

Exclusion Criteria:

• Local anesthetic allergy
• Skin or localized infection at the site of catheter insertion
• Patient or parent refusal

Related Conditions & MeSH terms

• Musculoskeletal Diseases
• Orthopedic Disorder

Intervention

Drug:
• Ropivacaine Hcl 0.5% Inj Vil 20Ml
Anesthetic agent used in peripheral nerve block

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Nationwide Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total Time to Perform the Regional Anesthesia Technique	The amount of time if takes to perform either the FICB or LPB.	Baseline
Secondary	Opioid Consumption in the PACU	Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).	Immediately to 1 hour post-op
Secondary	Post-op Pain Scores	Pain scores during the post-operative recovery period. Pain score scale is 0-10 with 0 being no pain and 10 being worst pain imaginable.	48 hours post-op