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

Pain Clinical Trial

— Dex ISB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02506660
• Other study ID #: 2014-379
• Status: Completed
• Phase: Phase 4
• Start date: August 2015
• Est. completion date: November 2016

Study information

• Verified date: July 2018
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 2016
• Est. primary completion date: November 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain
• Shoulder Arthroscopy

Intervention

Drug:
• Bupivacaine

• Perineural dexamethasone
Dexamethasone in nerve block
• Intravenous dexamethasone

• Intravenous saline

• Perineural saline
Saline in nerve block

Locations

Country	Name	City	State
United States	Hospital for Special Surgery	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nerve Block Duration	Time at which the pain relief from the block has completely worn off	Postoperative day 2+
Secondary	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)
Secondary	Opioid Consumption		Postoperative day 2, postoperative day 3
Secondary	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
Secondary	Block Satisfaction	0-10 scale (0=not satisfied; 10=extremely satisfied)	Postoperative day 2, postoperative day 3
Secondary	Block-related Complications		Postoperative day 7-10
Secondary	% 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