Ignite Creation Date:
2024-05-06 @ 7:16 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02506660
Status:
COMPLETED
Last Update Posted:
2018-08-29
First Post:
2015-07-02
Brief Title:
Interscalene Block With Low-dose IV vs Perineural Dexamethasone for Shoulder Arthroscopy
Sponsor:
Hospital for Special Surgery New York
Organization:
Hospital for Special Surgery New York
Study Overview
Official Title:
Interscalene Block With Low-dose IV vs Perineural Dexamethasone for Shoulder Arthroscopy
Status:
COMPLETED
Status Verified Date:
2018-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Dex ISB
Brief 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 andor 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None