NCT01805661

Brief Summary

To compare early ambulation and ability to participate in rehabilitation in patients undergoing total knee replacement using two different nerve block techniques for pain control. The 2 methods are 1) Adductor canal block with posterior capsular injection 2) femoral nerve block with tibial nerve block

Trial Health

87
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable pain

Timeline
Completed

Started Mar 2013

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

March 1, 2013

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

March 4, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 6, 2013

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

March 17, 2015

Status Verified

January 1, 2015

Enrollment Period

9 months

First QC Date

March 4, 2013

Last Update Submit

March 16, 2015

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)

Femoral With Tibial Nerve Block

ACTIVE COMPARATOR

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

Procedure: Femoral with Tibial Nerve Block

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

Interventions

Continuous Adductor canal block with 15-30ml of ropivacaine 0.1% with epinephrine 1:400,000 followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days post operatively. This is combined with ultrasound guided posterior capsular knee injection with 30 ml ropivacaine 0.1% with epinephrine 1:400,000.

Canal Block and Capsular Injection

Continuous femoral nerve block with 15 ml of ropivacaine 0.1% followed by an infusion of ropivacaine 0.1% at 6 ml per hour for 2 days after surgery combined with tibial nerve block in the popliteal fossa with ropivacaine 0.1% up to 15 ml.

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:

  • Patients having primary, unilateral total knee arthroplasty
  • ages 18 - 80

You may not qualify if:

  • history of neurological disease
  • neuropathy
  • diabetes
  • major systemic illness
  • pregnancy
  • chronic narcotic use
  • allergy to local anesthetic solution or NSAIDS
  • inability to give consent or cooperate with the study protocol
  • BMI\> 40

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 and Medical Center

    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

March 4, 2013

First Posted

March 6, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

March 17, 2015

Record last verified: 2015-01

Locations