FNB in ACL Recon Under SA
Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under Spinal Anesthesia: A Randomized Controlled Trial
1 other identifier
interventional
100
1 country
1
Brief Summary
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2023
Longer than P75 for not_applicable
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
September 13, 2023
CompletedStudy Start
First participant enrolled
September 18, 2023
CompletedFirst Posted
Study publicly available on registry
September 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 18, 2028
September 22, 2023
September 1, 2023
5 years
September 13, 2023
September 20, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
postoperative pain after 24hours
VAS (Visual analog scale) measured 24 hours after operation * the unabbreviated scale title: The visual analog scale * the minimum and maximum values: 0, 10 * higher scores mean a worse outcome.
24hours
Secondary Outcomes (1)
postoperative pain after 1, 3, 6, 12, 18, 48 hours
1, 3, 6, 12, 18, 48 hours
Study Arms (2)
FNB
EXPERIMENTALsono-guided injection with 20ml ropivacaine
no FNB
PLACEBO COMPARATORsono-guided injection with 20ml 0.9% saline
Interventions
After spinal anesthesia, patients will be injected around femoral nerve using ultrasonography.
After spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.
After spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.
Eligibility Criteria
You may qualify if:
- individuals who are scheduled to undergo arthroscopic anterior cruciate ligament reconstruction surgery and must be received sufficient explanation about the research prior to surgery and have provided their informed consent to participate.
You may not qualify if:
- who require simultaneous surgery for concomitant cartilage injury, medial meniscus tear, and lateral collateral ligament tear.
- who have previously undergone surgical treatment within the knee joint.
- who have declined to participate in the research.
- where medical, surgical, or anesthetic complications occurred during surgery.
- other cases deemed necessary by the researchers.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Chuncheon Sacred Heart Hospital
Chuncheon, Gangwon-do, 24253, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
September 13, 2023
First Posted
September 21, 2023
Study Start
September 18, 2023
Primary Completion (Estimated)
September 18, 2028
Study Completion (Estimated)
September 18, 2028
Last Updated
September 22, 2023
Record last verified: 2023-09