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
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