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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01459861
Other study ID # 11-09-003
Secondary ID
Status Terminated
Phase N/A
First received October 6, 2011
Last updated March 4, 2013
Start date October 2011
Est. completion date September 2012

Study information

Verified date February 2013
Source Saint Francis Care
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date September 2012
Est. primary completion date September 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

- knee arthroplasty

- ages 18-80

Exclusion Criteria:

- 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Caregiver), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Canal Block and Capsular Injection
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.
Femoral Nerve Block with Tibial Nerve Block
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.

Locations

Country Name City State
United States Saint Francis Hospital and Medical Center Hartford Connecticut

Sponsors (1)

Lead Sponsor Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. No
Secondary Pain scores at rest and with knee flexion. Measures of pain score using numeric pain rating scale (0=no pain, 10=worst pain) completed by patient in recovery room and every 6 hours for a 72 hour period after discharge from recovery room. Up to 3 days ( 72 hours) after surgery No
Secondary Pain Medication Consumption Amount of opioid consumption post surgery for 72 hours. Up to 3 days (72 hours) post surgery No
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