Intravenous Dexamethasone to Increase the Analgesic Duration of Interscalene Block
- 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
- 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
- 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
Group Intervention Description Normal Saline 20 mL intravenous Normal Saline Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block Dexamethasone 10 mg intravenous Dexamethasone Dexamethasone 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 intravenous Dexamethasone Dexamethasone 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
Name Time Method Duration of Analgesia 48 hours after surgery Defined as the time between the performance of the block and the first analgesic request
- Secondary Outcome Measures
Name Time Method Pain Scores every 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 Block 24 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 Satisfaction 48 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 Disturbance 24 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