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More info
You can access this
clinical trial
if you have
Anterior Cruciate Ligament Reconstruction or Regional Anesthesia, Saphenous Nerve Block
and you are
between 16 and 65
years old
4
The primary goal of this phase is to monitor the long-term effects.
The treatment is already on the market.
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The purpose

For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia. Depending on the randomized treatment assignment, patients may receive one of the following: 1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone); 2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone; 3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone. Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.

Provided treatments

  • Drug: Bupivacaine Only
  • Drug: Bupivacaine with 1 mg of Dexamethasone
  • Drug: Bupivacaine with 4 mg of Dexamethasone

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: NCT01586806. The sponsor of the trial is Hospital for Special Surgery, New York and it is looking for 195 volunteers for the current phase.
Official trial title:
Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction