Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

NCT00923598 | Completed Phase 4 Results

• 1 other identifier: Cleveland TKA Study
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Total Knee Arthroplasty; Knee Pain

Keywords

TKA; Bilateral; Cleveland Clinic; UCSD; Catheter; Nerve block; Postoperative pain; Femoral Catheter; Bilateral Total Knee Arthroplasty; Bilateral Femoral Catheter

Outcome Measures

Primary Outcomes (1)

• Quadriceps Femoris Muscle Strength Maximum Voluntary Isometric Contraction (MVIC)

  A device was used called a dynamometer to measure the force during maximum voluntary isometric contraction. The dynamometer was placed on ipsilateral anterior tibia perpendicular to the tibial crest, just proximal to the medial malleolus. Subjects were asked to take 2 seconds to come to maximum effort contracting the quadriceps, maintain this effort for 5 seconds, and then relax.

  morning of postoperative day 2

Study Arms (2)

1) 0.1% Ropivicaine on Right Leg

ACTIVE COMPARATOR

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

2) 0.4% Ropivicaine on Right Leg

ACTIVE COMPARATOR

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

Interventions

0.1% and 0.4% perineural ropivicaine DRUG

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.

1) 0.1% Ropivicaine on Right Leg; 2) 0.4% Ropivicaine on Right Leg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Primary, bilateral TKA
• Age 18 years or older
• Postoperative analgesic pain includes bilateral continuous femoral nerve blocks

You may not qualify if:

• Chronic, high-dose opioid use
• History of opioid abuse
• Any neuro-muscular deficit of either femoral nerves and/or quadriceps muscles
• Pregnancy
• Incarceration

Sponsors & Collaborators

• University of California, San Diego: lead
• The Cleveland Clinic: collaborator

Study Sites (1)

The Cleveland Clinic, Main Campus

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Limitations and Caveats

Study may not be applicable to other catheter designs or insertion techniques; local anesthetic types, concentrations, or doses; infusion delivery methods or durations; and certainly anatomic catheter locations.

Results Point of Contact

• Title: Dr. Brian Ilfeld, Professor of Anesthesiology, In Residence
• Organization: University of California San Diego

bilfeld@ucsd.edu

(858) 444-5949

Study Officials

• Daniel I Sessler, M.D.

  The Cleveland Clinic, Chair, Department of Outcomes Research

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, In Residence

Study Record Dates

• First Submitted: June 17, 2009
• First Posted: June 18, 2009
• Study Start: June 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 2, 2019
• Results First Posted: December 2, 2019

Record last verified: 2019-11

Locations

US (1)