Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks
1 other identifier
interventional
15
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2019
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 16, 2018
CompletedFirst Posted
Study publicly available on registry
November 20, 2018
CompletedStudy Start
First participant enrolled
April 24, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
January 31, 2020
CompletedResults Posted
Study results publicly available
March 3, 2022
CompletedMarch 3, 2022
February 1, 2022
9 months
November 16, 2018
February 9, 2022
February 9, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Total Time to Perform the Regional Anesthesia Technique
The amount of time if takes to perform either the FICB or LPB.
Baseline
Secondary Outcomes (2)
Opioid Consumption in the PACU
Immediately to 1 hour post-op
Post-op Pain Scores
48 hours post-op
Study Arms (2)
Fascia iliaca compartment block (FICB)
ACTIVE COMPARATORFICB 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.
Lumbar plexus block (LPB)
ACTIVE COMPARATORLPB 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.
Interventions
Anesthetic agent used in peripheral nerve block
Eligibility Criteria
You may qualify if:
- ASA grade I-III
- Undergoing elective orthopedic surgical procedures involving the hip and upper thigh
You may not qualify if:
- Local anesthetic allergy
- Skin or localized infection at the site of catheter insertion
- Patient or parent refusal
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
MeSH Terms
Conditions
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Senthil Krishna
- Organization
- Nationwide Children's Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending Anesthesiologist
Study Record Dates
First Submitted
November 16, 2018
First Posted
November 20, 2018
Study Start
April 24, 2019
Primary Completion
January 31, 2020
Study Completion
January 31, 2020
Last Updated
March 3, 2022
Results First Posted
March 3, 2022
Record last verified: 2022-02
Data Sharing
- IPD Sharing
- Will not share