FNB in ACL Recon Under SA
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Sono-guided injection, Ropivacaine injection, Saline injection.
- Who it may be relevant to
- Registry conditions: Anterior Cruciate Ligament Rupture, Femoral Nerve Block. Basic parameters: 19 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under Spinal Anesthesia: A Randomized Controlled Trial
Overview
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.
Detailed description
This study is a randomized controlled trial of 100 patients, who underwent history taking, physical examinations, x-rays, and MRI or ultrasonography, and were diagnosed with anterior cruciate ligament rupture from september 2023 to august 2028. The 100 patients will be assigned to Group I (with femoral nerve block) or Group II (without femoral nerve block) under double-blinded randomization. The randomization will be performed by an independent nurse using a computerized random sequence generator. The operators who participated in the procedure will be blinded to the participant's information. Both group will undergo spinal anesthesia for arthroscopic anterior cruciate ligament reconstruction. After anesthesia, sono-guided femoral nerve block will be performed. The injection for group1 is 20 mL ropivacaine and for groupII is 20 mL 0.9% saline. A visual analog scale (VAS) for pain will be recorded 1, 3, 6, 12, 18, 24, 36, 48 hours after the operation. VAS scores range from 0 to 10, with 0 being no pain and 10 being the most severe pain ever experienced. Injection with ultrasonography will be performed by a single anesthesiologist. 3 orthopedic surgeons will perform the surgery.
Interventions
- Procedure Sono-guided injection
After spinal anesthesia, patients will be injected around femoral nerve using ultrasonography. - Drug Ropivacaine injection
After spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve. - Drug Saline injection
After spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.
Primary outcome measures
- postoperative pain after 24hours [Time frame: 24hours]
Secondary outcome measures (1)
- postoperative pain after 1, 3, 6, 12, 18, 48 hours [Time frame: 1, 3, 6, 12, 18, 48 hours]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Supportive care
Study locations
South Korea · 1 center
- Chuncheon Sacred Heart Hospital — Chuncheon
Identifiers
NCT: NCT06048874 · 2023-07-022-001