Shoulder ArthroscopyPhase 4SCB & IV DexNCT02688530
Intravenous Dexamethasone on Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy
A Phase 4 study testing IV Saline, IV Dexamethasone 4mg and IV Dexamethasone 6mg in people with Shoulder Arthroscopy and Pain, run by Hospital for Special Surgery, New York at 1 site in United States.
Trial summary
Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Arthroscopy, Pain
- What is being tested?
- IV Saline, IV Dexamethasone 4mg and IV Dexamethasone 6mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 19 Nov 2017
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients undergoing shoulder arthroscopy under regional anesthesia
Who cannot join
- General anesthesia
- Contraindication to regional anesthesia
- Pre-existing neuropathy in the surgical limb
- Diabetes Mellitus
- History of postoperative nausea and vomiting \&/ or motion sickness
- Procedures involving biceps tenotomy
Show all 11Show fewer
- Peri-articular cocktail injections given intraoperatively to augment pain relief
- Chronic pain (daily opioid and/or gabapentinoid use for 6 weeks)
- Open surgical procedures
- Corticosteroid injection within 1 month
- Patients on systemic oral or IV steroid therapy within 6 months
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital for Special Surgery
New York, New York, 10021
About this study
Official title: Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study
Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. There remains a paucity of research on the effective dose range of IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.
Read the detailed description
Numerous studies have confirmed that perineural dexamethasone prolongs bupivacaine and ropivacaine brachial plexus blocks by approximately 10 hours (from approx. 12 to 22 hours) without clinical evidence of toxicity. However, perineural toxicity in an animal model has raised concern about its use as a peripheral nerve block adjuvant. Moreover, recent studies suggest that high dose IV dexamethasone (810mg) prolongs analgesia to a similar degree as perineural dexamethasone for interscalene, supraclavicular and sciatic nerve blocks performed with ropivacaine and bupivacaine. However these studies only utilized fixed, high level doses of IV dexamethasone. Moreover, there remains a concern that high dose IV dexamethasone may lead to postoperative hyperglycemia and could possibly increase the risk of postoperative wound infection. Open surgery under general anesthesia has been shown to increase blood glucose levels with a peak at approximately 2 hours post-induction and results have been conflicting regarding whether or not IV dexamethasone causes greater increase. To the investigators' knowledge, it is not yet known if arthroscopic surgery under regional anesthesia triggers a similar increase in blood glucose levels and if this is impacted by administration of IV dexamethasone. The investigators aim to identify the duration of supraclavicular block prolongation that can be expected over a range of doses of IV dexamethasone. The investigators also seek to identify what association, if any, is noted between IV dexamethasone and changes in blood glucose levels after shoulder surgery with regional anesthesia and sedation. Finally, the investigators will collect data on side effects and postoperative complications, if any, in patients receiving a range of doses of IV dexamethasone.
- Conditions
- Shoulder Arthroscopy, Pain
- Being tested
- IV Saline, IV Dexamethasone 4mg, IV Dexamethasone 6mg, IV Dexamethasone 8mg
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV SalineDrug
IV Dexamethasone 4mgDrug
IV Dexamethasone 6mgDrug
IV Dexamethasone 8mgDrug
| Study group | Role | What they receive |
|---|---|---|
| 0mg IV Dexamethasone | Placebo comparator | 0mg IV Dexamethasone Receives: Drug: IV Saline |
| 4mg IV Dexamethasone | Experimental | 4mg IV Dexamethasone Receives: Drug: IV Dexamethasone 4mg |
| 6mg IV Dexamethasone | Experimental | 6mg IV Dexamethasone Receives: Drug: IV Dexamethasone 6mg |
| 8mg IV Dexamethasone | Experimental | 8mg IV Dexamethasone Receives: Drug: IV Dexamethasone 8mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.
Measured: Day of Surgery until Post-Operative Day 3 (if the block persists)
Secondary outcomes (8)
Duration of Motor Block From the Supraclavicular Block
Defined as the time from block placement to restoration of normal strength at both the wrist and elbow.
Measured: Day of Surgery until Post-Operative Day 3 (if the block persists)
Blood Glucose Levels
Fingerstick blood glucose test to be administered before and 1-hour and 2-hours after IV dexamethasone administration.
Measured: Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration
Occurrence of Postoperative Neuropraxia
Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Measured: Post-Operative Day 21
Occurrence of Postoperative Wound Infection
Documentation of any of these occurrences will be obtained from the surgeons and/or medical charts after the postoperative follow up visit.
Measured: Post-Operative Day 21
Average Daily Pain Scores at Rest and With Movement
Using the Numeric Rating Scale (NRS) Pain obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Measured: Day of Surgery until Post-Operative Day 3 (if the block persists)
Worst Daily Pain Scores at Rest and With Movement
Using the numeric pain rating scale (NRS), will be obtained by patient interview. Lower numbers represent less pain and better outcomes. The scale range is from 0 (no pain) to 10 (worst pain possible).
Measured: Day of Surgery until Post-Operative Day 3 (if the block persists)
Patient Satisfaction With Postoperative Analgesia
Patient satisfaction with postoperative analgesia will be obtained by patient interview. Lower numbers represent worse outcomes. The scale range is from 0 (worst) to 10 (best).
Measured: Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)
Cumulative Daily Opioid Usage
Dosages (reported in Morphine equivalent units) of opioid medication obtained by medical records and/or by patient interview.
Measured: Recovery Room until Post-Operative Day 3 (if block persists)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2016 (estimated)
- Study startMay 2016
- Primary completion19 Nov 2017
- Study completion19 Nov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Hospital for Special Surgery, New YorkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital for Special Surgery, New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Meghan Kirksey, MD, PhD, Principal investigator, Hospital for Special Surgery, New York
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02688530
- Sponsor's protocol ID
- 2015-853
- Acronym
- SCB & IV Dex
- Status last verified
- May 2022
- First submitted
- 18 Feb 2016
- Last updated
- 13 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Dexamethasone for Prolongation of Analgesia Following Supraclavicular Brachial Plexus Block for Shoulder Arthroscopy: A Randomized, Controlled, Phase IV Dose-Response Study
- ClinicalTrials.gov ID
- NCT02688530
- Acronym / sponsor ID
- SCB & IV Dex / 2015-853
- Conditions
- Shoulder Arthroscopy, Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Hospital for Special Surgery, New YorkUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- 19 Nov 2017 (actual)
- Study completion
- 19 Nov 2017 (actual)
- First posted
- 23 Feb 2016 (estimated)
- Results
- Posted 13 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Previous studies have confirmed that IV dexamethasone prolongs brachial plexus blocks. However, these studies only used fixed doses of IV dexamethasone at relatively high doses, which could potentially lead to increased glucose levels, delayed wound healing, and unintended side effects. There remains a paucity of research on the effective dose range of IV dexamethasone for the prolongation of supraclavicular blocks. The optimal dosage of IV dexamethasone for prolongation of analgesia vs. motor block prolongation from supraclavicular blocks in shoulder surgery has yet to be delineated.
Detailed description
Numerous studies have confirmed that perineural dexamethasone prolongs bupivacaine and ropivacaine brachial plexus blocks by approximately 10 hours (from approx. 12 to 22 hours) without clinical evidence of toxicity. However, perineural toxicity in an animal model has raised concern about its use as a peripheral nerve block adjuvant. Moreover, recent studies suggest that high dose IV dexamethasone (810mg) prolongs analgesia to a similar degree as perineural dexamethasone for interscalene, supraclavicular and sciatic nerve blocks performed with ropivacaine and bupivacaine. However these studies only utilized fixed, high level doses of IV dexamethasone. Moreover, there remains a concern that high dose IV dexamethasone may lead to postoperative hyperglycemia and could possibly increase the risk of postoperative wound infection. Open surgery under general anesthesia has been shown to increase blood glucose levels with a peak at approximately 2 hours post-induction and results have been conflicting regarding whether or not IV dexamethasone causes greater increase. To the investigators' knowledge, it is not yet known if arthroscopic surgery under regional anesthesia triggers a similar increase in blood glucose levels and if this is impacted by administration of IV dexamethasone. The investigators aim to identify the duration of supraclavicular block prolongation that can be expected over a range of doses of IV dexamethasone. The investigators also seek to identify what association, if any, is noted between IV dexamethasone and changes in blood glucose levels after shoulder surgery with regional anesthesia and sedation. Finally, the investigators will collect data on side effects and postoperative complications, if any, in patients receiving a range of doses of IV dexamethasone.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0mg IV Dexamethasone | Placebo comparator | Drug: IV Saline0mg IV Dexamethasone |
| 4mg IV Dexamethasone | Experimental | Drug: IV Dexamethasone 4mg4mg IV Dexamethasone |
| 6mg IV Dexamethasone | Experimental | Drug: IV Dexamethasone 6mg6mg IV Dexamethasone |
| 8mg IV Dexamethasone | Experimental | Drug: IV Dexamethasone 8mg8mg IV Dexamethasone |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing shoulder arthroscopy under regional anesthesia
Key exclusion criteria (11 listed)
- General anesthesia
- Contraindication to regional anesthesia
- Pre-existing neuropathy in the surgical limb
- Diabetes Mellitus
- History of postoperative nausea and vomiting \&/ or motion sickness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IV Saline | Drug | 0mg IV Dexamethasone |
| IV Dexamethasone 4mg | Drug | 4mg IV Dexamethasone |
| IV Dexamethasone 6mg | Drug | 6mg IV Dexamethasone |
| IV Dexamethasone 8mg | Drug | 8mg IV Dexamethasone |
Primary outcome
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy
Time frame: Day of Surgery until Post-Operative Day 3 (if the block persists)
Defined as time from block placement until "pain relief from the block completely wears off" in the operative shoulder.
8 secondary outcomes
Duration of Motor Block From the Supraclavicular Block
Time frame: Day of Surgery until Post-Operative Day 3 (if the block persists)
Blood Glucose Levels
Time frame: Day of Surgery - before and 1-hour and 2-hours after IV Dexamethasone administration
Occurrence of Postoperative Neuropraxia
Time frame: Post-Operative Day 21
Occurrence of Postoperative Wound Infection
Time frame: Post-Operative Day 21
Average Daily Pain Scores at Rest and With Movement
Time frame: Day of Surgery until Post-Operative Day 3 (if the block persists)
Worst Daily Pain Scores at Rest and With Movement
Time frame: Day of Surgery until Post-Operative Day 3 (if the block persists)
Patient Satisfaction With Postoperative Analgesia
Time frame: Post-Operative Day 2 or Post-Operative Day 3 (if the block persists)
Cumulative Daily Opioid Usage
Time frame: Recovery Room until Post-Operative Day 3 (if block persists)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Not yet recruitingObservational study
Irrigation Fluid Volume, Tube Cuff Pressure, and Neck Swelling During Shoulder Arthroscopy
Shoulder Arthroscopy, Endotracheal Tube Cuff Pressure
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Use of a Smartphone App to Support Pre- and Post-Surgical Preparedness and to Improve Clinical Outcomes in Patients Undergoing Shoulder Arthroscopy
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Magnesium Sulfate With Standard Combined Costoclavicular-Suprascapular Block for Pain Relief After Shoulder Arthroscopy.
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Enrolling by invitation
Effect of Optimal Biological Volume Bupivacaine Liposome Interscalene Brachial Plexus Block on Postoperative Analgesia After Shoulder Arthroscopy
Pain and Diaphragmatic Dysfunction After Shoulder Arthroscopy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meghan Kirksey, MD, PhD principal investigator
Hospital for Special Surgery, New York
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing IV Saline, IV Dexamethasone 4mg and IV Dexamethasone 6mg in people with Shoulder Arthroscopy and Pain, 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 1 inclusion and 11 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 13 May 2022. 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. Some participants in this study may receive a placebo. 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 13 May 2022). 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?
Duration of Analgesia From a Supraclavicular Block Performed for Shoulder Arthroscopy (time frame: Day of Surgery until Post-Operative Day 3 (if the block persists)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.