Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks

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

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.

Study Overview

• Status: Completed
• Conditions: Orthopedic Disorder
• Intervention / Treatment: Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 18 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Fascia iliaca compartment block (FICB); 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.	Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml; Anesthetic agent used in peripheral nerve block; Other Names: Naropin
ACTIVE_COMPARATOR: Lumbar plexus block (LPB); 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.	Drug: Ropivacaine Hcl 0.5% Inj Vil 20Ml; Anesthetic agent used in peripheral nerve block; Other Names: Naropin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total Time to Perform the Regional Anesthesia Technique	The amount of time if takes to perform either the FICB or LPB.	Baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 24, 2019
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ACTUAL): January 31, 2020

Study Registration Dates

• First Submitted: November 16, 2018
• First Submitted That Met QC Criteria: November 16, 2018
• First Posted (ACTUAL): November 20, 2018

Study Record Updates

• Last Update Posted (ACTUAL): March 3, 2022
• Last Update Submitted That Met QC Criteria: February 9, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: IRB18-01102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No