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

Phase 4

Completed

Conditions: Pain
Shoulder Arthroscopy

Interventions: Drug: Bupivacaine
Drug: Intravenous dexamethasone
Drug: Perineural dexamethasone
Drug: Perineural saline
Drug: Intravenous saline

Registration Number: NCT02506660

Lead Sponsor: Hospital for Special Surgery, New York

Brief Summary: 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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intravenous dexamethasone	Intravenous dexamethasone	Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Intravenous dexamethasone	Perineural saline	Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Perineural dexamethasone	Perineural dexamethasone	Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Perineural dexamethasone	Intravenous saline	Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Intravenous dexamethasone	Bupivacaine	Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Perineural dexamethasone	Bupivacaine	Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.

Primary Outcome Measures

Name	Time	Method
Nerve Block Duration	Postoperative day 2+	Time at which the pain relief from the block has completely worn off

Secondary Outcome Measures

Name	Time	Method
% of Participants Who Guessed the Correct Group	Postoperative day 7-10	Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group
Numerical Rating Scale Pain Scores	Duration of stay in recovery room after surgery (average of 3 hours)	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")
Side Effects	Postoperative day 2, postoperative day 3	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)
Block-related Complications	Postoperative day 7-10
Opioid Consumption	Postoperative day 2, postoperative day 3
Block Satisfaction	Postoperative day 2, postoperative day 3	0-10 scale (0=not satisfied; 10=extremely satisfied)