CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 48 enrolled
Drug / intervention
0.1% and 0.4% perineural ropivicainedrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00923598
NCT00923598Phase 4Completed

Optimizing Local Anesthetic Concentration for Continuous Femoral Nerve Blocks

University of California, San Diego·interventional·Posted Jun 18, 2009·Updated Dec 2, 2019

In Brief

A Phase 4 clinical trial evaluating 0.1% and 0.4% perineural ropivicaine for Total Knee Arthroplasty and Knee Pain. Completed, enrolled 48 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedJun 18, 2009
Enrollment StartJun 1, 2009
Primary CompletionApr 1, 2011
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 17.0 years ago

Interventions

0.1% and 0.4% perineural ropivicainedrug

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.