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PainPhase 4Dex ISBNCT02506660

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

A Phase 4 study testing Bupivacaine, Perineural dexamethasone and Intravenous dexamethasone in people with Pain and Shoulder Arthroscopy, run by Hospital for Special Surgery, New York at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Pain, Shoulder Arthroscopy
What is being tested?
Bupivacaine, Perineural dexamethasone and Intravenous dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
128 participants
Where
1 siteUnited States
Study dates
Aug 2015to Nov 2016
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

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.

Being tested
Bupivacaine, Perineural dexamethasone, Intravenous dexamethasone, Intravenous saline, Perineural saline
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BupivacaineDrug

  • Perineural dexamethasoneDrug

    Dexamethasone in nerve block

  • Intravenous dexamethasoneDrug

  • Intravenous salineDrug

  • Perineural salineDrug

    Saline in nerve block

Study groups in NCT02506660
Study groupRoleWhat they receive
Intravenous dexamethasoneActive comparatorPatients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline.
Receives: Drug: Bupivacaine; Drug: Intravenous dexamethasone; Drug: Perineural saline
Perineural dexamethasoneExperimentalPatients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone.
Receives: Drug: Bupivacaine; Drug: Perineural dexamethasone; Drug: Intravenous saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Nerve Block Duration

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

    Measured: Postoperative day 2+

Secondary outcomes (6)

  1. 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")

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

  2. Opioid Consumption

    Measured: Postoperative day 2, postoperative day 3

  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)

    Measured: Postoperative day 2, postoperative day 3

  4. Block Satisfaction

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

    Measured: Postoperative day 2, postoperative day 3

  5. Block-related Complications

    Measured: Postoperative day 7-10

  6. % of Participants Who Guessed the Correct Group

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

    Measured: Postoperative day 7-10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Jul 2015 (estimated)
  2. Study startAug 2015
  3. Primary completionNov 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
128 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02506660
Sponsor's protocol ID
2014-379
Acronym
Dex ISB
Status last verified
Jul 2018
First submitted
2 Jul 2015
Last updated
29 Aug 2018

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.

    PubMed 29889698

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine, Perineural dexamethasone and Intravenous dexamethasone in people with Pain and Shoulder Arthroscopy, run by Hospital for Special Surgery, New York at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 29 Aug 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nerve Block Duration (time frame: Postoperative day 2+). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02506660, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2018.

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