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

• Status: Completed
• Trial end date: 2014-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital for Special Surgery, New York
• Treatments: Anesthetics; Anesthetics, Local; BB 1101; Bupivacaine; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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).