Anesthesia, Local, Shoulder Surgery
Conditions
Keywords
ropivacaine, bupivacaine, glucocorticoid
Brief summary
This study will test the hypothesis that adding dexamethasone significantly prolongs the duration of ropivacaine and bupivacaine analgesia, and that the magnitude of the effect differs among the two local anaesthetics.. Participants will be patients undergoing shoulder surgery with an interscalene nerve block.
Detailed description
This is a double-blinded randomized study of four groups of patients undergoing shoulder surgery using interscalene nerve blocks. Participants will be randomized into one of four groups: * Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline (placebo) for interscalene block; * Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline (placebo); * Ropivacaine and steroid: 30 ml 0.5% ropivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic; * Bupivacaine and steroid: 30 ml 0.5% bupivacaine plus dexamethasone 8 mg (2 ml) mixed with the local anesthetic. The primary outcome is the duration of the interscalene nerve block which is time to first analgesic request after PACU discharge. Kaplan-Meier survival density estimation and stratified Cox proportional hazard regression were used to compare groups.
Interventions
DRUGsaline
2 ml 0.9% saline (placebo)
DRUGDexamethasone
dexamethasone 8 mg (2 ml)
DRUGropivacaine
30 ml 0.5% ropivacaine
DRUGBupivacaine
30 ml 0.5% bupivacaine
Sponsors
The Cleveland Clinic
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Age between 18 and 75 years * Patients undergoing shoulder procedures, such as rotator cuff repair, capsular shift, shoulder arthroplasty, subacromial decompression
Exclusion criteria
* Contraindications to interscalene block (Coagulopathy, infection at the needle insertion site, moderate to severe chronic obstructive pulmonary disease, contralateral pneumothorax or diaphragmatic paralysis) * Pregnancy * Pre-existing neuropathy involving the surgical limb * Systemic glucocorticoid treatment (for 2 weeks or more) within six months of surgery * Chronic opioid use (greater than 30 mg oral oxycodone equivalent per day)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block | Postoperative day 1, 2 and 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Time to First Report of Pain | Postoperative day 1, 2 and 3 | — |
| Median Maximum VAS Pain Scores at Rest | Postoperative day 1, 2 and 3 | Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicatesno pain at all and ten indicates worst pain imaginable. , The higher of the score, the worse of the pain. |
| Total Three-day Opioid Consumption in Oral Oxycodone Equivalent | Postoperative day 1, 2 and 3 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Group 1 Ropivacaine: 30 ml 0.5% ropivacaine plus 2 ml 0.9% saline for interscalene block
Ropivacaine
Placebo: saline | 54 |
| Group 2 Group 2 Bupivacaine: 30 ml 0.5% bupivacaine plus 2 ml 0.9% saline
Bupivacaine
Placebo: saline | 56 |
| Group 3 Group 3 Ropivacaine and dexamethasone:
Ropivacaine plus dexamethasone
Ropivacaine
Dexamethasone: steroid | 54 |
| Group 4 Group 4 Bupivacaine and steroid:
Bupivacaine plus dexamethasone
Bupivacaine
Dexamethasone: steroid | 54 |
| Total | 218 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Group 3 | Group 4 | Total |
|---|---|---|---|---|---|
| Age, Continuous | 55 years | 60 years | 59 years | 58 years | 58 years |
| Sex: Female, Male Female | 21 Participants | 19 Participants | 21 Participants | 22 Participants | 83 Participants |
| Sex: Female, Male Male | 33 Participants | 37 Participants | 33 Participants | 32 Participants | 135 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 54 | 0 / 56 | 0 / 54 | 0 / 54 |
| serious Total, serious adverse events | 0 / 54 | 0 / 56 | 0 / 54 | 0 / 54 |
Outcome results
Primary
The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block
Time frame: Postoperative day 1, 2 and 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block | 11.8 hours |
| Group 2 | The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block | 14.8 hours |
| Group 3 | The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block | 22.2 hours |
| Group 4 | The Duration of the Interscalene Nerve Block Which is Time to First Administration of Pain Medication After Block | 22.4 hours |
Secondary
Median Maximum VAS Pain Scores at Rest
Visual Analogue Scale (VAS) pain scale is used to describe the severity or intensity of pain. It ranges from 0 to 10. Zero indicatesno pain at all and ten indicates worst pain imaginable. , The higher of the score, the worse of the pain.
Time frame: Postoperative day 1, 2 and 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Median Maximum VAS Pain Scores at Rest | 5 units on a scale |
| Group 2 | Median Maximum VAS Pain Scores at Rest | 5 units on a scale |
| Group 3 | Median Maximum VAS Pain Scores at Rest | 4 units on a scale |
| Group 4 | Median Maximum VAS Pain Scores at Rest | 3 units on a scale |
Secondary
Time to First Report of Pain
Time frame: Postoperative day 1, 2 and 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Time to First Report of Pain | 11.9 hours |
| Group 2 | Time to First Report of Pain | 14.7 hours |
| Group 3 | Time to First Report of Pain | 22.3 hours |
| Group 4 | Time to First Report of Pain | 25.7 hours |
Secondary
Total Three-day Opioid Consumption in Oral Oxycodone Equivalent
Time frame: Postoperative day 1, 2 and 3
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Group 1 | Total Three-day Opioid Consumption in Oral Oxycodone Equivalent | 75 milligrams |
| Group 2 | Total Three-day Opioid Consumption in Oral Oxycodone Equivalent | 85 milligrams |
| Group 3 | Total Three-day Opioid Consumption in Oral Oxycodone Equivalent | 79 milligrams |
| Group 4 | Total Three-day Opioid Consumption in Oral Oxycodone Equivalent | 60 milligrams |