Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Meniscal Tear Under Spinal Anesthesia: A Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- postoperative pain after 24hours
Study Overview
Brief Summary
The investigators will compare the results of sono-guided femoral nerve block in arthroscopic surgery for meniscal tear 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 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 spinal 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 19 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Not provided
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.
Arms & Interventions
FNB
sono-guided femoral nerve injection with 20ml ropivacaine
Intervention: Sono-guided injection (Procedure)
No FNB
sono-guided femoral nerve injection with 20ml 0.9% saline
Intervention: Sono-guided injection (Procedure)
No FNB
sono-guided femoral nerve injection with 20ml 0.9% saline
Intervention: Saline injection (Drug)
FNB
sono-guided femoral nerve injection with 20ml ropivacaine
Intervention: Ropivacaine injection (Drug)
Outcomes
Primary Outcomes
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
- postoperative pain after 1, 3, 6, 12, 18, 48 hours(1, 3, 6, 12, 18, 48 hours)
Investigators
Jung-Taek Hwang
Professor
Chuncheon Sacred Heart Hospital