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

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.

Study Overview

• Status: Completed
• Conditions: Pain; Shoulder Arthroscopy
• Intervention / Treatment: Drug: Bupivacaine; Drug: Intravenous saline; Drug: Intravenous dexamethasone; Drug: Perineural saline; Drug: Perineural dexamethasone

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Hospital For Special Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intravenous dexamethasone; 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; Saline in nerve block
Experimental: Perineural dexamethasone; 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: Intravenous saline; Drug: Perineural dexamethasone; Dexamethasone in nerve block

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Richard Kahn, Hospital for Special Surgery, New York

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 1, 2016
• Study Completion (Actual): November 1, 2016

Study Registration Dates

• First Submitted: July 2, 2015
• First Submitted That Met QC Criteria: July 21, 2015
• First Posted (Estimate): July 23, 2015

Study Record Updates

• Last Update Posted (Actual): August 29, 2018
• Last Update Submitted That Met QC Criteria: July 31, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Protease Inhibitors; Anesthetics, Local; Dexamethasone; Dexamethasone acetate; BB 1101; Bupivacaine
• Other Study ID Numbers: 2014-379