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More info
You can access this
clinical trial
if you have
Major Ankle Surgery
and you are
over 18
years old
-
The phase for this study is not defined.
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The purpose

The most useful method to manage pain after major ankle surgery is infusion of local analgesics with a catheter close to the sciatic nerve. Sensation from the ankle are carried by three nerves: The tibial and peroneal nerve (unified in the sciatic nerve) and the saphenous nerve. Study purpose is to test whether continuous infusion of local analgesics by saphenous nerve catheter provide a better treatment of pain in comparison with a single injection nerve block. In addition cost-effectiveness of the two methods are compared. The 50 patients of the trial are randomized in clusters of ten. We intend to do a preliminary analysis of the data from the first 40 patients. However, it is not an interim analysis. Fifty patients will be included independent of the result of the preliminary analysis. The random allocation of the last 10 patients will also be double-blinded.

Provided treatments

  • Procedure: Continuous saphenous nerve block
  • Procedure: Placebo

Locations near you

Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Tris trial is registered with FDA with number: NCT01445210. The sponsor of the trial is University of Aarhus and it is looking for 50 volunteers for the current phase.
Official trial title:
A Randomized Comparison of Single Injection vs. Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block in Postoperative Pain Treatment After Major Ankle Surgery: Clinical Outcome and Cost Analysis