Sponsor study identifier
interventional
24
1 country
1
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 2013
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
July 9, 2013
Actual (reported)July 12, 2013
Actual (reported)November 2013
Actual (reported)November 2013
Actual (reported)March 19, 2021
Actual (reported)Maximum Tolerance to Transcutaneous Electrical Stimulation
Electrocardiogram pads are placed on the lateral aspect of the plantar surface of the foot which is covered by the sciatic nerve distribution; and, the tolerance to cutaneous electrical current is obtained using a nerve stimulator. The current is increased from 0 mA until subjects detect the electrical current (up to a maximum of 80 mA), at which time the current is recorded and the nerve stimulator turned off.
Hour 6
Maximum Tolerance to Transcutaneous Electrical Stimulation
baseline, Hours 1-14 (except 6 which was the primary outcome) and Hour 22
Percent of Maximum Voluntary Isometric Contraction Baseline (Quadriceps Femoris)
baseline, Hours 1-14 and Hour 22
Bilateral sciatic perineural catheters were inserted and ropivacaine administered as a basal infusion concurrently. For the right catheter, ropivacaine 0.1% was infused at 8 mL/h basal for 6 hours. For the left catheter, ropivacaine 0.4% was infused at 2 mL/h for 6 hours.
Bilateral sciatic perineural catheters were inserted and ropivacaine administered as a basal infusion concurrently. For the right catheter, ropivacaine 0.4% was infused at 8 mL/h basal for 6 hours. For the left catheter, ropivacaine 0.1% was infused at 2 mL/h for 6 hours.
A sciatic catheter was inserted and ropivacaine 0.1% was administered as a basal infusion for 6 hours.
University California San Diego
San Diego, California, 92103, United States
Madison SJ, Monahan AM, Agarwal RR, Furnish TJ, Mascha EJ, Xu Z, Donohue MC, Morgan AC, Ilfeld BM. A randomized, triple-masked, active-controlled investigation of the relative effects of dose, concentration, and infusion rate for continuous popliteal-sciatic nerve blocks in volunteers. Br J Anaesth. 2015 Jan;114(1):121-9. doi: 10.1093/bja/aeu333. Epub 2014 Sep 23.
Brian M Ilfeld, MD, MS
University California San Diego
24 participants (actual enrollment reported by the registry).
First Submitted
July 9, 2013
First Posted
A sciatic catheter was inserted and ropivacaine 0.4% was administered as a basal infusion for 6 hours.
Contact the study team to confirm eligibility.
July 12, 2013
Study Start
July 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
November 2013
Actual (reported)Study Completion
November 2013
Actual (reported)Last Updated
March 19, 2021
Results First Posted
March 19, 2021
Record last verified: 2021-03
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Source: ClinicalTrials.gov.
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