Clinical Trials Directory

Trials / Completed

CompletedNCT02412657

Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

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
Phase
N/A
Study type
Interventional
Enrollment
75 (actual)
Sponsor
Maisonneuve-Rosemont Hospital · Academic / Other
Sex
All
Age
18 Years – 80 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DRUGDexamethasoneAfter the performance of inter scalene plexus blockade, patients will either receive dexamethasone 10 mg i.v. (diluted with 17.5 mL normal saline), dexamethasone 4 mg i.v. (diluted with 19 mL normal saline), or normal saline 20 ml i.v.
DRUGNormal Saline

Timeline

Start date
2014-09-01
Primary completion
2015-10-01
Completion
2015-11-01
First posted
2015-04-09
Last updated
2018-09-13
Results posted
2016-04-12

Locations

3 sites across 1 country: Canada

Source: ClinicalTrials.gov record NCT02412657. Inclusion in this directory is not an endorsement.