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Completed

NCT Number: NCT02506660

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital for Special Surgery

New York, 10021, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bupivacaine

Drug

Perineural dexamethasone

Drug

Dexamethasone in nerve block

intravenous dexamethasone

Drug

Intravenous saline

Drug

Perineural saline

Drug

Saline in nerve block

Primary outcomes

  1. Nerve Block Duration

    Time frame: Postoperative day 2+

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

Secondary outcomes

  1. Numerical Rating Scale Pain Scores

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

    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")

  2. Opioid Consumption

    Time frame: Postoperative day 2, postoperative day 3

  3. Side Effects

    Time frame: Postoperative day 2, postoperative day 3

    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)

  4. Block Satisfaction

    Time frame: Postoperative day 2, postoperative day 3

    0-10 scale (0=not satisfied; 10=extremely satisfied)

  5. Block-related Complications

    Time frame: Postoperative day 7-10

  6. % of Participants Who Guessed the Correct Group

    Time frame: Postoperative day 7-10

    Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Acronym: Dex ISB

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 23, 2015
Registry last updated
Aug 29, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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