Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

Phase 2

Completed

• Conditions: Orthopedic Disorder
• Interventions: Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml

• Registration Number: NCT03746951
• Lead Sponsor: Nationwide Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-11-16
• Study First Submitted QC: 2018-11-16
• Study First Posted: 2018-11-20
• Study Start: 2019-04-24
• Primary Completion: 2020-01-31
• Study Completion: 2020-01-31
• Status Verified: 2022-02
• Results First Submitted: 2022-02-09
• Results First Submitted QC: 2022-02-09
• Last Update Submitted: 2022-02-09
• Results First Posted: 2022-03-03
• Last Update Posted: 2022-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Lumbar plexus block (LPB)	Ropivacaine Hcl 0.5% Inj Vil 20Ml	LPB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the back.
Fascia iliaca compartment block (FICB)	Ropivacaine Hcl 0.5% Inj Vil 20Ml	FICB is a local anesthetic nerve block, a type of local anesthesia, used for the hip, thigh, and knee. It is performed by inserting the needle into the groin.

Primary Outcome Measures

Name	Time	Method
Total Time to Perform the Regional Anesthesia Technique	Baseline	The amount of time if takes to perform either the FICB or LPB.

Secondary Outcome Measures

Name	Time	Method
Opioid Consumption in the PACU	Immediately to 1 hour post-op	Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).
Post-op Pain Scores	48 hours post-op	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.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States