Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy (Dex ISB)

Hospital for Special Surgery (HSS)

Status and phase: Completed; Phase 4

Conditions: Shoulder Arthroscopy; Pain

Treatments: Drug: Perineural dexamethasone; Drug: Intravenous saline; Drug: Bupivacaine; Drug: Intravenous dexamethasone; Drug: Perineural saline

Study type: Interventional

Funder types: Other

Identifiers

NCT02506660

2014-379

Details and patient eligibility

About

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.

Enrollment: 128 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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128 participants in 2 patient groups

Intravenous dexamethasone

Active Comparator group

Description:

Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.

Treatment:

Drug: Perineural saline

Drug: Intravenous dexamethasone

Drug: Bupivacaine

Perineural dexamethasone

Experimental group

Description:

Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.

Treatment:

Drug: Bupivacaine

Drug: Intravenous saline

Drug: Perineural dexamethasone