- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02506660
Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy (Dex ISB)
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
New York
-
New York, New York, United States, 10021
- Hospital for Special Surgery
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
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.
|
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.
|
Dexamethasone in nerve block
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Nerve Block Duration
Time Frame: Postoperative day 2+
|
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
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")
|
Duration of stay in recovery room after surgery (average of 3 hours)
|
Opioid Consumption
Time Frame: Postoperative day 2, postoperative day 3
|
Postoperative day 2, postoperative day 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) |
Postoperative day 2, postoperative day 3
|
Block Satisfaction
Time Frame: Postoperative day 2, postoperative day 3
|
0-10 scale (0=not satisfied; 10=extremely satisfied)
|
Postoperative day 2, postoperative day 3
|
Block-related Complications
Time Frame: Postoperative day 7-10
|
Postoperative day 7-10
|
|
% 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
|
Postoperative day 7-10
|
Collaborators and Investigators
Investigators
- Principal Investigator: Richard Kahn, Hospital for Special Surgery, New York
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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