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NCT02506660 · ClinicalTrials.gov registry record · Phase 4
Interscalene Block With Low-dose IV vs. Perineural Dexamethasone for Shoulder Arthroscopy
A Phase 4 study, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 128
- Enrollment target
NCT02506660 is a Phase 4 study that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 128 participants.
The verdict
NCT02506660, a Phase 4 study, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 128 participants
- Enrollment target
Study 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.
Interventions
- DRUG Bupivacaine
- DRUG Intravenous saline
- DRUG Perineural dexamethasone
- DRUG Intravenous dexamethasone
- DRUG Perineural saline
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 128 participants |
| Start Date | 2015-08 |
| Est. Completion | 2016-11 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02506660
The ClinicalTrials.gov registry entry for NCT02506660 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 128 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Bupivacaine is the first listed.
NCT02506660 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02506660 about?
NCT02506660 is a clinical study titled "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 d...
What is the current status of trial NCT02506660?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 128 participants. The study started on 2015-08. Estimated completion is 2016-11.
What interventions are being tested in trial NCT02506660?
The interventions under investigation include: Bupivacaine (DRUG), Intravenous saline (DRUG), Perineural dexamethasone (DRUG), Intravenous dexamethasone (DRUG), Perineural saline (DRUG).
Who is sponsoring clinical trial NCT02506660?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
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