FNB in ACL Recon Under SA

Not Applicable

Not yet recruiting

• Conditions: Anterior Cruciate Ligament Rupture; Femoral Nerve Block
• Interventions: Procedure: Sono-guided injection; Drug: Ropivacaine injection; Drug: Saline injection

• Registration Number: NCT06048874
• Lead Sponsor: Chuncheon Sacred Heart Hospital

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.

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.

Study Timeline

• Status Verified: 2023-09
• Study First Submitted: 2023-09-13
• Study Start: 2023-09-18
• Study First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-20
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-22
• Primary Completion: 2028-09-18
• Study Completion: 2028-09-18

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FNB	Sono-guided injection	sono-guided injection with 20ml ropivacaine
FNB	Ropivacaine injection	sono-guided injection with 20ml ropivacaine
no FNB	Sono-guided injection	sono-guided injection with 20ml 0.9% saline
no FNB	Saline injection	sono-guided injection with 20ml 0.9% saline

Primary Outcome Measures

Name	Time	Method
postoperative pain after 24hours	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 Outcome Measures

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

Trial Locations

Locations (1)

Chuncheon Sacred Heart Hospital; 🇰🇷 Chuncheon, Gangwon-do, Korea, Republic of