drugset / Trial / NCT01586806

Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction

NCT01586806 ↗

Phase 4 Completed 195 enrolled Hospital for Special Surgery, New York
RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2012-07
Primary completion
2014-11
Completion
2014-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Dexamethasone Small molecule 1 mg Other
Comparator Dexamethasone Small molecule 4 mg Other
Comparator Bupivacaine Other / unclassified 0.5 % Other
Comparator Bupivacaine Other / unclassified 13 ml Other

Indications

No indication recorded.