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Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block

Not Applicable
Completed
Conditions
Pain
Interventions
Drug: Normal Saline
Registration Number
NCT02412657
Lead Sponsor
Maisonneuve-Rosemont Hospital
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
75
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Normal Saline 20 mL intravenousNormal SalineNormal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Dexamethasone 10 mg intravenousDexamethasoneDexamethasone 10 mg diluted with Normal Saline 17,5 mL i.v. (20 mL total) injected slowly during 30 seconds immediately after performing interscalene brachial plexus block
Dexamethasone 4 mg intravenousDexamethasoneDexamethasone 4 mg diluted with Normal Saline 19 mL i.v. (20 mL total) injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Primary Outcome Measures
NameTimeMethod
Duration of Analgesia48 hours after surgery

Defined as the time between the performance of the block and the first analgesic request

Secondary Outcome Measures
NameTimeMethod
Pain Scoresevery 6 hours during the first 48 hours after surgery

On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)

Residual Motor Block24 hours and 48 hours

Scale of 0-2 (0:inability to move fingers, 1: fingers able to move, with diminished strength compared to non operated side, 2: No motor weakness of the fingers)

Patients Overall Satisfaction48 hours

categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others

Sleep Disturbance24 hours and 48 hours

Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)

Trial Locations

Locations (3)

Hopital Pierre-Boucher

🇨🇦

Longueuil, Quebec, Canada

Maisonneuve-Rosemont Hospital

🇨🇦

Montreal, Quebec, Canada

Hopital Hotel-Dieu de Sorel

🇨🇦

Sorel, Quebec, Canada

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