Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, Saphenous Nerve Block
Intervention: Bupivacaine Only; Bupivacaine with 1 mg of Dexamethasone; Bupivacaine with 4 mg of Dexamethasone
Intervention description: This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).; This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.; This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; Bupivacaine; BB 1101
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 195.0
Sex: All
Minimum age: 16 Years
Maximum age: 65 Years
Healthy volunteers: No
Keywords: Dexamethasone; Glucocorticoids; Physiological Effects of Drugs; Therapeutic Uses; Anterior Cruciate Ligament Reconstruction; Regional Anesthesia, nerve block; Ultrasonic Imaging; Post-Operative Complications: muscle weakness, pain, nausea and vomiting; Dexamethasone (as local anesthetic additive)

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.
    

Eligibility 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).