Clinical trial NCT02412657: Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Lead sponsor: Maisonneuve-Rosemont Hospital
Sponsor class: OTHER
First posted: 2015-04-09
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

* Elective shoulder arthroscopy under ropivacaine single-shot interscalene brachial plexus block anesthesia (rotator cuff repair and shoulder decompression)
* ASA I-III
* Age 18-80 years old

Exclusion Criteria:

* Any contraindication to interscalene brachial plexus block anesthesia
* Interscalene brachial plexus block failure
* Known local anesthetics allergy
* Dexamethasone allergy or intolerance
* Any contraindication to acetaminophen
* Any contraindication to morphine or hydromorphone
* Brachial plexus neuropathies
* Chronic pain syndrome other than shoulder pain
* Routine use of opioid medication
* Routine use of systemic corticosteroid
* Pregnancy
* Weight below 50 kilograms
* Incapability to understand a numeric verbal pain scale
* Incapability to consent
* Patient refusal

Primary outcomes:
measure: Duration of Analgesia
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Pain Scores
timeFrame: every 6 hours during the first 48 hours after surgery
measure: Residual Motor Block
timeFrame: 24 hours and 48 hours
measure: Sleep Disturbance
timeFrame: 24 hours and 48 hours
measure: Patients Overall Satisfaction
timeFrame: 48 hours
Other outcomes:
Locations:
city: Longueuil
country: Canada
facility: Hopital Pierre-Boucher
state: Quebec
city: Montreal
country: Canada
facility: Maisonneuve-Rosemont Hospital
state: Quebec
city: Sorel
country: Canada
facility: Hopital Hotel-Dieu de Sorel
state: Quebec
Study officials:
affiliation: Maisonneuve-Rosemont Hospital
name: Veronique Brulotte, MD MSc FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chalifoux F, Colin F, St-Pierre P, Godin N, Brulotte V. Low dose intravenous dexamethasone (4 mg and 10 mg) significantly prolongs the analgesic duration of single-shot interscalene block after arthroscopic shoulder surgery: a prospective randomized placebo-controlled study. Can J Anaesth. 2017 Mar;64(3):280-289. doi: 10.1007/s12630-016-0796-6. Epub 2017 Jan 3.