FNB in Meniscal Tear Under GA

Chuncheon Sacred Heart Hospital

Status: Not yet enrolling

Conditions: Femoral Nerve Block; Meniscus Tear

Treatments: Drug: Saline injection; Drug: Ropivacaine injection; Procedure: Sono-guided injection

Study type: Interventional

Funder types: Other

Identifiers

NCT06045884

2023-07-019-001

Details and patient eligibility

About

The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear under general anesthesia

Full 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 meniscal tear 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 general anesthesia for arthroscopic meniscal surgery. 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• individuals who are scheduled to undergo meniscal 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, 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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups, including a placebo group

FNB

Experimental group

Description:

sono-guided femoral nerve injection with 20ml ropivacaine

Treatment:

Drug: Ropivacaine injection

Procedure: Sono-guided injection

No FNB

Placebo Comparator group

Description:

sono-guided femoral nerve injection with 20ml 0.9% saline

Treatment:

Drug: Saline injection

Procedure: Sono-guided injection