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

Study Overview
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Brief Summary
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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: 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone); 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone; 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.

Official Title
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Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction

Conditions
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Anterior Cruciate Ligament Reconstruction, Regional Anesthesia, Saphenous Nerve Block

Intervention / Treatment
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* Drug: Bupivacaine Only
* Drug: Bupivacaine with 1 mg of Dexamethasone
* Drug: Bupivacaine with 4 mg of Dexamethasone


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control<br> | Drug: Bupivacaine Only<br>* 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).<br>|
| Active Comparator: Dexamethasone 1 mg<br> | Drug: Bupivacaine with 1 mg of Dexamethasone<br>* 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.<br>|
| Active Comparator: Dexamethasone 4 mg<br> | Drug: Bupivacaine with 4 mg of Dexamethasone<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-perceived Duration of Analgesia | After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution. | Up to 2 days following surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NRS (Numerical Rating Scale) Pain Scores | Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable. | Postoperative day 1 | 
| Patient Satisfaction | Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied); | Up to 2 days following surgery | 
| Postoperative Morphine Consumption | Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge. | Up to 2 days following surgery | 
| Opioid-Related Side Effects (Drowsiness) | Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms. | Up to 2 days following surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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)