FNB in Meniscal Tear Under GA

September 20, 2023 updated by: Jung-Taek Hwang, Chuncheon Sacred Heart Hospital

Effects of Sono-guided Femoral Nerve Block in Arthroscopic Surgery for Meniscal Tear Under General Anesthesia: A Randomized Controlled Trial

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gangwon-do
      • Chuncheon, Gangwon-do, Korea, Republic of, 24253
        • Chuncheon Sacred Heart Hospital
        • Principal Investigator:
          • Jung-Taek Hwang, MD, PhD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: FNB
sono-guided femoral nerve injection with 20ml ropivacaine
Procedure: Sono-guided injection
After general anesthesia, patients will be injected around femoral nerve using ultrasonography.
Drug: Ropivacaine injection
After general anesthesia, patients will be injected 20ml ropivacaine around femoral nerve.
Placebo Comparator: No FNB
sono-guided femoral nerve injection with 20ml 0.9% saline
Procedure: Sono-guided injection
After general anesthesia, patients will be injected around femoral nerve using ultrasonography.
Drug: Saline injection
After general anesthesia, patients will be injected 20ml 0.9% saline around femoral nerve.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1, 3, 6, 12, 18, 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Chuncheon Sacred Heart Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 18, 2023

Primary Completion (Estimated)

September 18, 2026

Study Completion (Estimated)

September 18, 2026

Study Registration Dates

First Submitted

September 13, 2023

First Submitted That Met QC Criteria

September 19, 2023

First Posted (Actual)

September 21, 2023

Study Record Updates

Last Update Posted (Actual)

September 22, 2023

Last Update Submitted That Met QC Criteria

September 20, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-07-019-001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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