Back to resultsComparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks
Primary Purpose
Orthopedic Disorder
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine Hcl 0.5% Inj Vil 20Ml
Sponsored by
About this trial
This is an interventional treatment trial for Orthopedic Disorder
Eligibility Criteria
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
Sites / Locations
- Nationwide Children's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Fascia iliaca compartment block (FICB)
Lumbar plexus block (LPB)
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Total Time to Perform the Regional Anesthesia Technique
The amount of time if takes to perform either the FICB or LPB.
Secondary Outcome Measures
Opioid Consumption in the PACU
Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).
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.
Full Information
NCT ID
NCT03746951
First Posted
November 16, 2018
Last Updated
February 9, 2022
Sponsor
Nationwide Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03746951
Brief Title
Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks
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.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
April 24, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
January 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nationwide Children's Hospital
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Orthopedic Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fascia iliaca compartment block (FICB)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Lumbar plexus block (LPB)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hcl 0.5% Inj Vil 20Ml
Other Intervention Name(s)
Naropin
Intervention Description
Anesthetic agent used in peripheral nerve block
Primary Outcome Measure Information:
Title
Total Time to Perform the Regional Anesthesia Technique
Description
The amount of time if takes to perform either the FICB or LPB.
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
Opioid Consumption in the PACU
Description
Total number of subjects that required opioids to control pain in the post-anesthesia care unit (PACU).
Time Frame
Immediately to 1 hour post-op
Title
Post-op Pain Scores
Description
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.
Time Frame
48 hours post-op
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Nationwide Children's Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparative Evaluation of Lumbar Plexus and Suprainguinal Fascia Iliaca Compartment Blocks
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