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NCT Number: NCT06048874

FNB in ACL Recon Under SA

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for anterior cruciate ligament reconstruction under spinal anesthesia.

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Key information

Age range

19 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Sono-guided injection

Procedure

After spinal anesthesia, patients will be injected around femoral nerve using ultrasonography.

Ropivacaine injection

Drug

After spinal anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.

Saline injection

Drug

After spinal anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.

Primary outcomes

  1. postoperative pain after 24hours

    Time frame: 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.

Secondary outcomes

  1. postoperative pain after 1, 3, 6, 12, 18, 48 hours

    Time frame: 1, 3, 6, 12, 18, 48 hours

    VAS (Visual analog scale) measured 1, 3, 6, 12, 18, 48 hours after operation

    • the unabbreviated scale title: The visual analog scale
    • the minimum and maximum values: 0, 10
    • higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Chuncheon Sacred Heart Hospital

Other

Registry information

Official study title

Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Anterior Cruciate Reconstruction Under Spinal Anesthesia: A Randomized Controlled Trial

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Sep 21, 2023
Registry last updated
Sep 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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