Ignite Creation Date:
2025-12-24 @ 7:04 PM
Ignite Modification Date:
2025-12-26 @ 11:50 AM
Study NCT ID:
NCT02412657
Status:
COMPLETED
Last Update Posted:
2018-09-13
First Post:
2015-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block
Sponsor:
Maisonneuve-Rosemont Hospital
Organization:
Study Overview
Official Title:
Impact of Two Doses of Intravenous Dexamethasone on the Analgesic Duration of a Single-shot Interscalene Block With Ropivacaine for Shoulder Arthroscopy; a Prospective, Randomized, Placebo-controlled Study
Status:
COMPLETED
Status Verified Date:
2018-08
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:
None
Brief Summary:
Interscalene brachial plexus block provides excellent but time limited analgesia. Intravenous dexamethasone increases the analgesic duration of a single-shot interscalene block with ropivacaine for shoulder arthroscopic surgery. We want to evaluate the effect of two different doses (dexamethasone 10 mg i.v. vs 4 mg i.v. vs placebo) on the analgesic duration of a single-shot inter scalene block. Our study hypothesis is that dexamethasone 4 mg i.v. is equivalent to dexamethasone10 mg i.v. in prolonging the analgesic duration of a single-shot interscalene block with ropivacaine.
Detailed Description:
75 patients will be randomly assigned to three groups:
* D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.
All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.
In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached \>3/10. They will note the time and day at which this outcome occurs.
* D10: dexamethasone 10 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* D4: dexamethasone 4 mg I.V. diluted in normal saline 20cc, immediately after inter scalene block
* C: control: Normal saline 20cc I.V., immediately after inter scalene block. These patient will be recruited from 3 hospitals, with two surgeons performing the surgeries.
All patients will have their surgery under regional anesthesia only provided by the inter scalene plexus block, with ropivacaine 0.5% 20cc.
In the postoperative period, patients will be given analgesic medication on an as needed basis. They will be instructed to take the first analgesic medication once postoperative shoulder pain has reached \>3/10. They will note the time and day at which this outcome occurs.
Study Oversight
Has Oversight DMC:
True
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?: