NCT06048341

Brief Summary

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

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
5mo left

Started Sep 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Sep 2023Sep 2026

First Submitted

Initial submission to the registry

September 13, 2023

Completed
5 days until next milestone

Study Start

First participant enrolled

September 18, 2023

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 21, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 18, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 18, 2026

Last Updated

September 22, 2023

Status Verified

September 1, 2023

Enrollment Period

3 years

First QC Date

September 13, 2023

Last Update Submit

September 20, 2023

Conditions

Meniscus TearFemoral Nerve Block

Keywords

Meniscus TearFemoral Nerve Block

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 injectionDrug: Ropivacaine injection

No FNB

PLACEBO COMPARATOR

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

Procedure: Sono-guided injectionDrug: Saline injection

Interventions

Sono-guided injectionPROCEDURE

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

FNBNo FNB
Ropivacaine injectionDRUG

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

FNB
Saline injectionDRUG

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

No FNB

Eligibility Criteria

Age19 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chuncheon Sacred Heart Hospital

Chuncheon, Gangwon-do, 24253, South Korea

Location

MeSH Terms

Interventions

RopivacaineSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium 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)