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

NCT02506660 | Completed Phase 4 Results

• 1 other identifier: 2014-379
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain; Shoulder Arthroscopy

Outcome Measures

Primary Outcomes (1)

• Nerve Block Duration

  Time at which the pain relief from the block has completely worn off

  Postoperative day 2+

Secondary Outcomes (6)

• Numerical Rating Scale Pain Scores

  Duration of stay in recovery room after surgery (average of 3 hours)

• Opioid Consumption

  Postoperative day 2, postoperative day 3

• Side Effects

  Postoperative day 2, postoperative day 3

• Block Satisfaction

  Postoperative day 2, postoperative day 3

• Block-related Complications

  Postoperative day 7-10

Study Arms (2)

Intravenous dexamethasone

ACTIVE COMPARATOR

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

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

Perineural dexamethasone

EXPERIMENTAL

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

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

Interventions

Bupivacaine DRUG

Intravenous dexamethasone; Perineural dexamethasone

Perineural dexamethasone DRUG

Dexamethasone in nerve block

Perineural dexamethasone

Intravenous dexamethasone DRUG

Intravenous dexamethasone

Intravenous saline DRUG

Perineural dexamethasone

Perineural saline DRUG

Saline in nerve block

Intravenous dexamethasone

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients having ambulatory arthroscopic shoulder surgery under ultrasound-guided interscalene block (rotator cuffs, acromioplasties, stabilizations, labral repairs, etc.)
• Age 18-70 years

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital for Special Surgery, New York: lead

Study Sites (1)

Hospital for Special Surgery

New York, New York, 10021, United States

Location

Related Publications (1)

• 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.

  PMID: 29889698 DERIVED

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Dr. Richard Kahn
• Organization: Hospital of Special Surgery

KahnR@HSS.EDU

212-774-7274

Study Officials

• Richard Kahn

  Hospital for Special Surgery, New York

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 2, 2015
• First Posted: July 23, 2015
• Study Start: August 1, 2015
• Primary Completion: November 1, 2016
• Study Completion: November 1, 2016
• Last Updated: August 29, 2018
• Results First Posted: August 29, 2018

Record last verified: 2018-07

Locations

US (1)