NCT01459861

Brief Summary

The purpose of this study is to assess early ambulation following total knee replacement in patients receiving continuous adductor canal block with posterior capsular injection compared to continuous femoral nerve block with tibial nerve block.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Oct 2011

Geographic Reach
1 country

1 active site

Status
terminated

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 Start

First participant enrolled

October 1, 2011

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

October 6, 2011

Completed
20 days until next milestone

First Posted

Study publicly available on registry

October 26, 2011

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
Last Updated

March 6, 2013

Status Verified

February 1, 2013

Enrollment Period

11 months

First QC Date

October 6, 2011

Last Update Submit

March 4, 2013

Conditions

Keywords

early ambulationknee arthroplasty

Outcome Measures

Primary Outcomes (1)

  • Ability to ambulate post operatively.

    Ability to ambulate and perform tasks of the rehabilitation program and reach rehabilitation milestones after total knee arthroplasty.

    Up to 3 days (72 hours) post surgery.

Secondary Outcomes (2)

  • Pain scores at rest and with knee flexion.

    Up to 3 days ( 72 hours) after surgery

  • Pain Medication Consumption

    Up to 3 days (72 hours) post surgery

Study Arms (2)

Canal Block and Capsular Injection

EXPERIMENTAL

Adductor canal block with a continuous catheter and ultrasound guided posterior capsular injection with local anesthetic solution.

Procedure: Canal Block and Capsular Injection

Femoral with Tibial Nerve Block

ACTIVE COMPARATOR

Continuous femoral nerve block with catheter and selective tibial nerve block in the popliteal fossa.

Procedure: Femoral Nerve Block with Tibial Nerve Block

Interventions

Continuous Adductor canal block with 15ml of ropivacaine 0.2% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30ml ropivacaine 0.2% with epinephrine 1:400,000.

Canal Block and Capsular Injection

Continuous femoral nerve block with 15ml of ropivacaine 0.2% followed by an infusion of ropivacaine 0.2% at 6ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.5% up to 15ml.

Femoral with Tibial Nerve Block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • knee arthroplasty
  • ages 18-80

You may not qualify if:

  • history of neurological disease
  • diabetes
  • pregnancy
  • neuropathy
  • chronic narcotic use
  • allergy to local anesthetic solution or NSAIDS
  • inability to give consent or cooperate with the study protocol

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

PainOsteoarthritis

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Sanjay Sinha, M.D.

    Saint Francis Hospital

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 6, 2011

First Posted

October 26, 2011

Study Start

October 1, 2011

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

March 6, 2013

Record last verified: 2013-02

Locations