CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 24 enrolled
Drug / intervention
Ropivacaine 0.1% +1 moredrug
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/NCT01898689
NCT01898689Phase 4Completed

Optimizing Local Anesthetic Concentration for Continuous Popliteal-Sciatic Nerve Blocks

University of California, San Diego·interventional·Posted Jul 12, 2013·Updated Mar 19, 2021

In Brief

A Phase 4 clinical trial evaluating Ropivacaine 0.1% and Ropivacaine 0.4% for Relatively Healthy Volunteers. Completed, enrolled 24 participants across 1 site.

Detailed Summary

A continuous peripheral nerve block-also termed "perineural local anesthetic infusion"-involves the insertion of a tiny tube (a "catheter") through the skin and adjacent to a peripheral nerve, followed by local anesthetic (numbing medicine) administration via the catheter, providing pain control following surgery. Continuous peripheral nerve blocks may be provided in the hospital setting, but the use of lightweight, portable pumps permits infusion at home as well. However, it remains unknown if the concentration of the local anesthetic influences the block effects; or, is it rather simply the total dose of medication that is important. If it is the latter, then the concentration of local anesthetic could be increased, allowing a decreased basal infusion rate, which would allow patients at home to receive twice the duration of potent pain control since their infusion pump local anesthetic reservoir would last twice as long as current practice. In addition, if one concentration/dose combination results in less muscle weakness, but with at least equivalent analgesia, then the risk of falling might be decreased as well. The investigators will test the hypothesis that providing ropivacaine at different concentrations and rates (0.1% at 8 mL/hour vs. 0.4% at 2 mL/hour)-but at an equivalent total basal (8 mg/hour)-produces comparable effects when used in a continuous popliteal-sciatic nerve block.

Study Details

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

Timeline

Phase 4CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 12, 2013
Enrollment StartJul 1, 2013
Primary CompletionNov 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 13.0 years ago

Interventions

Ropivacaine 0.1%drug

A sciatic catheter was inserted and ropivacaine 0.1% was administered as a basal infusion for 6 hours.

Ropivacaine 0.4%drug

A sciatic catheter was inserted and ropivacaine 0.4% was administered as a basal infusion for 6 hours.