NCT02513082

Brief Summary

This study aims to compare the effectiveness of adductor canal block and femoral nerve block in total knee arthroplasty in general anesthesia. Two block techniques were proved safe and effective in pain control after total knee arthroplasty. But some authors insist that quadriceps muscle power was decreased by femoral nerve block. The study design is a double-blind randomized controlled trial. Fifty patients planed to undergo simultaneously bilateral total knee arthroplasty are randomised to receive ultrasound-guided femoral nerve block on one leg and adductor canal block on the other, in addition to combined general anaesthesia. The primary outcome was comparative postoperative pain in either extremity at four, eight, 12, 24, 72 hours and 7days postoperatively. Secondary comparative outcomes included motor strength by cybex test.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

Typical duration for not_applicable

Status
unknown

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

First Submitted

Initial submission to the registry

July 28, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2015

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

November 5, 2015

Status Verified

November 1, 2015

Enrollment Period

1 year

First QC Date

July 28, 2015

Last Update Submit

November 3, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Visual pain scale

    Changes from the baseline visual pain scale to 1 week after surgery

Secondary Outcomes (1)

  • Changes in Quadriceps muscle power and strength by cybex muscle testing

    1 week postoperatively compared to baseline

Study Arms (2)

Femoral nerve block

EXPERIMENTAL

Femoral nerve block will be performed just one time after total knee arthroplasty in general anesthesia state

Procedure: Sono guided nerve block

Adductor canal block

ACTIVE COMPARATOR

Adductor canal block will be performed just one time after total knee arthroplasty in general anesthesia state

Procedure: Sono guided nerve block

Interventions

Sono guided nerve block is effectively and safely performed for pain relief after total knee arthroplasty

Also known as: femoral nerve block, adductor canal block
Adductor canal blockFemoral nerve block

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients for total knee arthroplasty having medicare insurance

You may not qualify if:

  • Alcohol, drug abuser Narcotics addiction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Koh HJ, Koh IJ, Kim MS, Choi KY, Jo HU, In Y. Does Patient Perception Differ Following Adductor Canal Block and Femoral Nerve Block in Total Knee Arthroplasty? A Simultaneous Bilateral Randomized Study. J Arthroplasty. 2017 Jun;32(6):1856-1861. doi: 10.1016/j.arth.2017.01.025. Epub 2017 Jan 26.

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Yong In, MD, PhD

    the Catholic Univerisity of Korea Seoul St Mary's hospital

    STUDY CHAIR

Central Study Contacts

Yong In, MD, PhD

CONTACT

Mansoo Kim, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2015

First Posted

July 31, 2015

Study Start

August 1, 2015

Primary Completion

August 1, 2016

Study Completion

August 1, 2017

Last Updated

November 5, 2015

Record last verified: 2015-11