Clinical trial NCT02506660: Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy
Official title: Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Shoulder Arthroscopy
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-07-23
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Nerve Block Duration
timeFrame: Postoperative day 2+
Secondary outcomes:
measure: Numerical Rating Scale Pain Scores
timeFrame: Duration of stay in recovery room after surgery (average of 3 hours)
measure: Opioid Consumption
timeFrame: Postoperative day 2, postoperative day 3
measure: Side Effects
timeFrame: Postoperative day 2, postoperative day 3
measure: Block Satisfaction
timeFrame: Postoperative day 2, postoperative day 3
measure: Block-related Complications
timeFrame: Postoperative day 7-10
measure: % of Participants Who Guessed the Correct Group
timeFrame: Postoperative day 7-10
Other outcomes:
Locations:
city: New York
country: United States
facility: Hospital for Special Surgery
state: New York
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Richard Kahn
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kahn RL, Cheng J, Gadulov Y, Fields KG, YaDeau JT, Gulotta LV. Perineural Low-Dose Dexamethasone Prolongs Interscalene Block Analgesia With Bupivacaine Compared With Systemic Dexamethasone: A Randomized Trial. Reg Anesth Pain Med. 2018 Aug;43(6):572-579. doi: 10.1097/AAP.0000000000000817.