Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy

Study Overview
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Brief Summary
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Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.

Official Title
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Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy

Conditions
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Pain, Shoulder Arthroscopy

Intervention / Treatment
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* Drug: Bupivacaine
* Drug: Perineural dexamethasone
* Drug: Intravenous dexamethasone
* Drug: Intravenous saline
* Drug: Perineural saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.) Age 18-70 years Exclusion Criteria: Contraindication to interscalene block Known allergy/sensitivity to any study medications Having taken daily steroids for 10 days or longer anytime during the past year Body mass index <18 or >40 History of uncontrolled nausea and vomiting with opioids or severe post-op nausea and vomiting (to prevent any need for higher doses of IV dexamethasone) Non-English speaking Revision procedures Additional procedures (e.g., removal of hardware, procedures involving other areas, etc.) Planned open procedures History of diabetes Arthroscopic irrigation and debridement secondary to infection Peripheral neuropathies affecting the operative extremity Having taken opiates daily for 10 days or longer immediately preceding surgery, 3 times a week for greater than 3 months anytime in the past year, or currently taking for anything other than shoulder pain

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intravenous dexamethasone<br>Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline. | Drug: Bupivacaine<br> <br> Drug: Intravenous dexamethasone<br> <br> Drug: Perineural saline<br>* Saline in nerve block<br>|
| Experimental: Perineural dexamethasone<br>Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone. | Drug: Bupivacaine<br> <br> Drug: Perineural dexamethasone<br>* Dexamethasone in nerve block<br>Drug: Intravenous saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nerve Block Duration | Time at which the pain relief from the block has completely worn off | Postoperative day 2+ | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale Pain Scores | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. no pain) to '10' representing the other pain extreme (e.g. pain as bad as you can imagine or worst pain imaginable) | Duration of stay in recovery room after surgery (average of 3 hours) | 
| Opioid Consumption |  | Postoperative day 2, postoperative day 3 | 
| Side Effects | Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only. For each symptom, severity is assessed by the question: (If yes), how severe was it usually? (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4) | Postoperative day 2, postoperative day 3 | 
| Block Satisfaction | 0-10 scale (0=not satisfied; 10=extremely satisfied) | Postoperative day 2, postoperative day 3 | 
| Block-related Complications |  | Postoperative day 7-10 | 
| % of Participants Who Guessed the Correct Group | Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group | Postoperative day 7-10 |