NCT04778774

Brief Summary

Adductor canal block and femoral nerve block are the most commonly used nerve blocks for pain control after total knee arthroplasty. The block area for adductor canal is a sensory branch near the knee area, which can potentially reduce the effect of motor blockage of quadriceps muscle. We try to proof adductor canal block can reduce the pain level after surgery effectively and preserve the muscle power of quadriceps muscle. Therefore, the rehabilitation course can be reduced and further lowering the risks of falling and complications.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 24, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

February 25, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 18, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2021

Completed
Last Updated

March 2, 2022

Status Verified

February 1, 2021

Enrollment Period

8 months

First QC Date

February 25, 2021

Last Update Submit

February 28, 2022

Conditions

Quadriceps Function Monitored With Electromyography

Outcome Measures

Primary Outcomes (1)

  • Quadriceps muscle Electromyography voltage level change before and after nerve block

    surface electromyography level

    compare difference of Quadriceps muscle Electromyography voltage level 12 weeks after surgery,data were measured post operation day 1, day 2, day 5, 2 weeks, 6 weeks and 12 weeks

Study Arms (2)

Adductor canal block group

EXPERIMENTAL

Adductor canal block group

Procedure: Nerve block

Femoral nerve block group

EXPERIMENTAL

Femoral nerve block group

Procedure: Nerve block

Interventions

Nerve blockPROCEDURE

Two different nerve block types, Adductor canal block group and Femoral nerve block group

Adductor canal block groupFemoral nerve block group

Eligibility Criteria

Age50 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age at least 50 years old, not exceed 100 years old
  • Diagnosed Primary Knee Osteoarthritis
  • Accepted Total Knee Arthroplasty

You may not qualify if:

  • Diagnosed Osteonecrosis
  • Diagnosed inflammatory Arthritis、Rheumatoid Arthritis
  • Accepted Revision Total Knee Arthroplasty
  • Quadriceps muscle rupture, suture or repair history
  • Neurological or orthopedic disorders that could affect quadriceps muscle power
  • Allergy to amide anesthetics
  • Patients who cannot obey or follow directions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kaohsiung Municipal Ta-Tung Hospital

Kaohsiung City, 80145, Taiwan

Location

MeSH Terms

Interventions

Nerve Block

Intervention Hierarchy (Ancestors)

Anesthesia, ConductionAnesthesiaAnesthesia and AnalgesiaDenervationNeurosurgical ProceduresSurgical Procedures, Operative

Study Officials

  • Hsuan-Ti Huang, M.D

    Kaohsiung Medical University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 25, 2021

First Posted

March 3, 2021

Study Start

February 24, 2021

Primary Completion

October 18, 2021

Study Completion

November 29, 2021

Last Updated

March 2, 2022

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

TW(1)