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Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

Information source: University of California, San Diego
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Total Knee Arthroplasty; Knee Pain

Intervention: 0.1% and 0.4% perineural ropivicaine (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: University of California, San Diego

Official(s) and/or principal investigator(s):
Daniel I Sessler, M.D., Principal Investigator, Affiliation: The Cleveland Clinic, Chair, Department of Outcomes Research

Summary

This is a randomized, observer-masked, controlled study. Subjects will be patients undergoing bilateral total knee arthroplasty (TKA). One side (left or right) will be randomized to one of two treatment groups: a postoperative ropivacaine concentration of 0. 1% or 0. 4%. The contralateral side will receive the other possible ropivacaine concentration of 0. 1% or 0. 4%. The basal rate and patient-controlled bolus volume will depend upon the treatment group, but the total dose of local anesthetic is the same for each. For the duration of the study, all patients will receive the current usual and customary analgesics for bilateral TKA patients. All patients will receive a ropivacaine perineural infusions initiated in the operating room and continued until at least the afternoon of postoperative day (POD) 2, as well as oral acetaminophen, a sustained-release oral opioid; and celecoxib. Rescue opioid and route of administration will be determined by pain severity using a Numeric Rating Scale of 0-10, with 0 equal to no pain and 10 being the worst imaginable pain.

Clinical Details

Official title: Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Quadriceps femoris muscle strength maximum voluntary isometric contraction (MVIC)

Detailed description: The investigators propose to test the null hypothesis that differing concentrations of ropivacaine (0. 1% vs. 0. 4%) at an equal total dose has no impact on quadriceps muscle strength during a continuous femoral nerve block following total knee arthroplasty (TKA). These results will help define the optimal concentration of local anesthetic used for continuous peripheral nerve blocks.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Primary, bilateral TKA

- Age 18 years or older

- Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

Exclusion Criteria:

- Chronic, high-dose opioid use

- History of opioid abuse

- Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles

- Pregnancy

- Incarceration

Locations and Contacts

The Cleveland Clinic, Main Campus, Cleveland, Ohio 44195, United States
Additional Information

Starting date: June 2009
Last updated: June 12, 2012

Page last updated: August 20, 2015

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