NCT02495805

Brief Summary

The purpose of the study is to compare continuous femoral nerve block with continuous proximal adductor canal block for postoperative pain control and rehabilitation.

Trial Health

15
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2015

Status
withdrawn

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

June 30, 2015

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 13, 2015

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2015

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

December 9, 2016

Status Verified

December 1, 2016

Enrollment Period

1.2 years

First QC Date

June 30, 2015

Last Update Submit

December 8, 2016

Conditions

Total Knee Arthroplasty

Keywords

a continuous proximal adductor canal block (ACB)continuous femoral nerve block (FNB)

Outcome Measures

Primary Outcomes (1)

  • Motor effects

    Subjects' change in motor effects will be assessed as maximum voluntary isometric contraction (MVIC) in the quadriceps muscle.

    24 hours (postoperatively)

Secondary Outcomes (5)

  • Pain score

    On average between 6 and 8 hours postoperatively

  • Pain score

    24 hours (postoperatively)

  • Opioid consumption

    On average between 6 and 8 hours postoperatively

  • Opioid consumption

    24 hours (postoperatively)

  • Motor effects

    On average between 6 and 8 hours postoperatively

Study Arms (2)

adductor canal block (ACB)

ACTIVE COMPARATOR

Subjects randomized to this groups receive a continuous proximal adductor canal block (ACB) during surgery.

Procedure: Continuous proximal adductor canal block

femoral nerve block (FNB)

ACTIVE COMPARATOR

Subjects randomized to this groups receive a continuous femoral nerve block (FNB) during surgery.

Procedure: Continuous femoral nerve block

Interventions

Continuous proximal adductor canal blockPROCEDURE

Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).

Also known as: ACB
adductor canal block (ACB)
Continuous femoral nerve blockPROCEDURE

Subjects will be randomized into 2 groups: those who will receive a continuous proximal adductor canal block (ACB) and those who will receive a continuous femoral nerve block (FNB).

Also known as: FNB
femoral nerve block (FNB)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score of 1 or 2 that are healthy without systemic disease or have mild systemic disease, respectively.
  • The patient will need to be able to have decision-making capacity and ability to consent for the study.

You may not qualify if:

  • Patients with an American Society of Anesthesiologists Physical Status Classification System (ASA) score greater than 2.
  • Patients unable to have decision-making capacity and ability to consent for the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Richa Wardham, MD

    Yale University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 13, 2015

Study Start

September 1, 2015

Primary Completion

November 1, 2016

Study Completion

November 1, 2016

Last Updated

December 9, 2016

Record last verified: 2016-12