Pain
Conditions
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.
Interventions
DRUGDexamethasone
After 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
Sponsors
Maisonneuve-Rosemont Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia | 48 hours after surgery | Defined as the time between the performance of the block and the first analgesic request |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| 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) |
| 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 |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone 10 mg Intravenous 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: After 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. | 24 |
| Dexamethasone 4 mg Intravenous 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
Dexamethasone: After 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. | 23 |
| Normal Saline 20 mL Intravenous Normal saline 20 mL injected slowly during 30 seconds, immediately after performing interscalene brachial plexus block
Normal Saline | 22 |
| Total | 69 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 0 |
| Overall Study | Protocol Violation | 0 | 2 | 3 |
Baseline characteristics
| Characteristic | Dexamethasone 10 mg Intravenous | Dexamethasone 4 mg Intravenous | Normal Saline 20 mL Intravenous | Total |
|---|---|---|---|---|
| Age, Continuous | 49 years | 54 years | 55 years | 53 years |
| Region of Enrollment Canada | 24 participants | 23 participants | 22 participants | 69 participants |
| Sex: Female, Male Female | 7 Participants | 11 Participants | 11 Participants | 29 Participants |
| Sex: Female, Male Male | 17 Participants | 12 Participants | 11 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 24 | 0 / 23 | 0 / 22 |
| serious Total, serious adverse events | 0 / 24 | 0 / 23 | 0 / 22 |
Outcome results
Primary
Duration of Analgesia
Defined as the time between the performance of the block and the first analgesic request
Time frame: 48 hours after surgery
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Dexamethasone 10 mg Intravenous | Duration of Analgesia | 19.1 hours |
| Dexamethasone 4 mg Intravenous | Duration of Analgesia | 19.6 hours |
| Normal Saline 20 mL Intravenous | Duration of Analgesia | 11.8 hours |
Secondary
Pain Scores
On a 11-points Verbal Numeric Scale 0-10 (0= no pain, 10= worst conceivable pain)
Time frame: every 6 hours during the first 48 hours after surgery
Secondary
Patients Overall Satisfaction
categorical data (1: very satisfied, would recommend this analgesia protocol to others, 0: not satisfied, would not recommend this analgesia protocol to others
Time frame: 48 hours
Secondary
Residual Motor Block
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)
Time frame: 24 hours and 48 hours
Secondary
Sleep Disturbance
Sleep disturbance scale 0-10 (0: no sleep disturbance from pain, 10: worst conceivable sleep disruption from pain)
Time frame: 24 hours and 48 hours