FNB in Meniscal Tear Under GA

NCT06045884 | Not Yet Recruiting DMC

• 1 other identifier: 2023-07-019-001
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Meniscus Tear; Femoral Nerve Block

Keywords

Femoral Nerve Block; Meniscus Tear

Outcome Measures

Primary Outcomes (1)

• postoperative pain after 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.

  24hours

Secondary Outcomes (1)

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

  1, 3, 6, 12, 18, 48 hours

Study Arms (2)

FNB

EXPERIMENTAL

sono-guided femoral nerve injection with 20ml ropivacaine

Procedure: Sono-guided injection; Drug: Ropivacaine injection

No FNB

PLACEBO COMPARATOR

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

Procedure: Sono-guided injection; Drug: Saline injection

Interventions

Sono-guided injection PROCEDURE

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

FNB; No FNB

Ropivacaine injection DRUG

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

FNB

Saline injection DRUG

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

No FNB

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• \- 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chuncheon Sacred Heart Hospital: lead

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

MeSH Terms

Interventions

Ropivacaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 13, 2023
• First Posted: September 21, 2023
• Study Start: September 18, 2023
• Primary Completion (Estimated): September 18, 2026
• Study Completion (Estimated): September 18, 2026
• Last Updated: September 22, 2023

Record last verified: 2023-09

Locations

KR (1)