Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Completed · Phase 4
Conditions studied: Anterior Cruciate Ligament Reconstruction, Regional Anesthesia, Saphenous Nerve Block
In brief
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.
Key facts
- Study ID
- NCT01586806
- Run by
- Hospital for Special Surgery, New York
- People needed
- 195
- Starts
- 2012-07-01
- Expected to finish
- 2014-12-01
- Last updated by the study team
- 2016-11-28
Who can join
Age: 16 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.
- ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system]
- BMI < 35
- Smokers included
- Ages 16-65
You may not qualify if…
- Patients on steroids or requiring stress dose steroids
- BMI > 35
- Patient refusal
- Allergy to study medications,
- NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks
- Lower extremity neurological dysfunction
- Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)
- Not in included age range (under 16 or over 65 years of age)
- Contraindications to the use of dexamethasone
- Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).
Where it is running
- Hospital for Special Surgery — New York, New York, United States
Full record on ClinicalTrials.gov
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