Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

This study has been completed.
Sponsor:
Collaborator:
The Cleveland Clinic
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego
ClinicalTrials.gov Identifier:
NCT00923598
First received: June 17, 2009
Last updated: June 12, 2012
Last verified: June 2012
  Purpose

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.


Condition Intervention Phase
Total Knee Arthroplasty
Knee Pain
Drug: 0.1% and 0.4% perineural ropivicaine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

Resource links provided by NLM:


Further study details as provided by University of California, San Diego:

Primary Outcome Measures:
  • Quadriceps femoris muscle strength maximum voluntary isometric contraction (MVIC) [ Time Frame: morning of postoperative day 2 ] [ Designated as safety issue: No ]

Enrollment: 48
Study Start Date: June 2009
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1) 0.1% Ropivicaine on Right Leg
Patients will be randomized ot 0.1% Ropivicaine infusion on the right leg and therefore 0.4% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.
Drug: 0.1% and 0.4% perineural ropivicaine
Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.
Active Comparator: 2) 0.4% Ropivicaine on Right Leg
Patients will be randomized ot 0.4% Ropivicaine infusion on the right leg and therefore 0.1% Ropivicain in fusion for the left leg for pain due to bilateral TKA. The outcome measures will be measured on both legs, starting with the right leg each time. The infusion will last for the two days following surgery, that the patient is staying in the hospital.
Drug: 0.1% and 0.4% perineural ropivicaine
Patients will be randomized to one of two groups: Ropivicaine 0.1% infusion on the right leg and Ropivicaine 0.4% infusion on the left leg, or Ropivicaine 0.4% infusion on the right leg and Ropiviciane 0.1% infusion on the left leg for treatment of postoperative pain following bilateral TKA. Both groups will receive the same total dose of medication and will have the infusion for the two days following surgery.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00923598

Locations
United States, Ohio
The Cleveland Clinic, Main Campus
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
University of California, San Diego
The Cleveland Clinic
Investigators
Principal Investigator: Daniel I Sessler, M.D. The Cleveland Clinic, Chair, Department of Outcomes Research
  More Information

No publications provided

Responsible Party: Brian M. Ilfeld, MD, MS, Associate Professor, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT00923598     History of Changes
Other Study ID Numbers: Cleveland TKA Study
Study First Received: June 17, 2009
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Diego:
TKA
Bilateral
Cleveland Clinic
UCSD
Catheter
Nerve block
Postoperative pain
Femoral Catheter
Bilateral Total Knee Arthroplasty
Bilateral Femoral Catheter

Additional relevant MeSH terms:
Anesthetics
Anesthetics, Local
Central Nervous System Agents
Central Nervous System Depressants
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014