Shoulder Injury
Conditions
Keywords
Pain blockade, Ropivacaine, Dexamethasone
Brief summary
Pre-operative perineural injection of dexamethasone mixed with local anesthetic in peripheral nerve blockade for orthopedic surgery has been shown to prolong the length of analgesia, improve visual analog pain scores, decrease post-operative opioid use, and decrease post-operative nausea. No study has been published to determine if this effect is a result of systemic absorption of dexamethasone or is a local effect of the drug on neuronal activity at the injection site. This study is a prospective, randomized, double-blind, controlled study to compare pain block with (1) ropivacaine and saline plus intravenous saline vs (2) ropivacaine and dexamethasone plus intravenous saline vs (3) ropivacaine and saline plus intravenous dexamethasone. Patients will be recruited sequentially and assigned to the three groups at random in equal ratios. The hypothesis is that dexamethasone injected perineurally in combination with ropivacaine for interscalene brachial plexus block will yield longer duration of sensory blockade as compared to ropivacaine alone without intravenous or perineural dexamethasone and as compared to ropivacaine and intravenous dexamethasone. This result will suggest that the effect of dexamethasone is a result of direct neuronal activity at the injection site versus systemic absorption.
Interventions
DRUGRopivacaine
25 ml ropivacaine 0.5%
DRUGDexamethasone
8 mg dexamethasone (perineural)
DRUGNormal saline
5 ml normal saline (intravenous)
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients undergoing elective shoulder surgery by one of two surgeons highly experienced in the procedure. 2. Patients are either: Opioid naïve; or Have not taken opiates for one month prior to surgery (tramadol is permissible). 3. Patients have an American Society of Anesthesiology physical status I-III.
Exclusion criteria
1. Females who are pregnant. 2. Patients who are taking chronic daily opiates for one month prior to surgery except tramadol. 3. Diabetic patients. 4. Patients with creatinine above 1.1mg/dL for females and above 1.3mg/dL for males. 5. Patients with contralateral pneumothorax or diaphragmatic paralysis. 6. Patients with coagulopathy. 7. Patients with clinically significant previous nerve injury in surgical extremity. 8. Patients with an allergy to NSAIDs. 9. Patients who are refusing a block. 10. Patients with a contraindication to ropivacaine, dexamethasone, or interscalene block due to other medical condition such as severe chronic obstructive pulmonary disease (COPD).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Sensory Blockade | Within 48 hours | Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post Operative Opioid Dose at 24 Hours | approximately 24 hours after surgery | — |
| Time Until First Dose of Analgesic | Approximately 10 hours after surgery | — |
| Patient Satisfaction With Pain Control | 24 hours, 48 hours, 1 week | Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at Mayo Clinic in Arizona from June 2012 to September 2014.
Pre-assignment details
238 patients were screened; of these 41 were excluded because they did not meet inclusion criteria, and 67 were excluded because they declined to be in the study.
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone Block Blockade with 25 ml ropivacaine 0.5% mixed with 8 mg dexamethasone (0.8 ml), and 5 ml intravenous normal saline | 42 |
| Dexamethasone IV Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and intravenous 8 mg dexamethasone (0.8 ml dexamethasone, 4.2 ml saline) to total volume of 5 ml | 37 |
| Placebo Blockade with 25 ml ropivacaine 0.5% mixed with 0.8 ml normal saline, and 5 ml intravenous normal saline | 41 |
| Total | 120 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 0 | 1 | 0 |
| Overall Study | Late exclusion before treatment | 2 | 3 | 2 |
| Overall Study | Protocol Violation | 0 | 1 | 1 |
Baseline characteristics
| Characteristic | Dexamethasone Block | Dexamethasone IV | Placebo | Total |
|---|---|---|---|---|
| Age, Continuous | 67.5 years STANDARD_DEVIATION 12.7 | 68.4 years STANDARD_DEVIATION 7.7 | 62.7 years STANDARD_DEVIATION 11.3 | 66.14 years STANDARD_DEVIATION 10.7 |
| Region of Enrollment United States | 42 participants | 37 participants | 41 participants | 120 participants |
| Sex: Female, Male Female | 13 Participants | 11 Participants | 21 Participants | 45 Participants |
| Sex: Female, Male Male | 29 Participants | 26 Participants | 20 Participants | 75 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 | 8 / 42 | 2 / 37 | 5 / 41 |
| serious Total, serious adverse events | 0 / 42 | 3 / 37 | 1 / 41 |
Outcome results
Primary
Duration of Sensory Blockade
Duration from time of block until complete resolution of sensory blockade in the shoulder is recorded in minutes by patient report.
Time frame: Within 48 hours
Population: Patients will be included in the primary analysis on the basis of intention to treat.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Block | Duration of Sensory Blockade | 16.9 hours | Standard Deviation 5.2 |
| Dexamethasone IV | Duration of Sensory Blockade | 18.2 hours | Standard Deviation 6.4 |
| Placebo | Duration of Sensory Blockade | 13.8 hours | Standard Deviation 3.8 |
p-value: 0.001ANOVA
Secondary
Patient Satisfaction With Pain Control
Pain was rated on a visual analogue scale with 0 = no pain, 3=mild pain, 5=moderate pain, 7=moderate to severe pain, and 10=severe pain.
Time frame: 24 hours, 48 hours, 1 week
Population: Patients analyzed for each category varied see explanations per row (time point): (n=dexamethasone block, dexamethasone IV, placebo).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Dexamethasone Block | Patient Satisfaction With Pain Control | 1 week (n=42, 36, 41) | 9.1 units on a scale | Standard Deviation 1.2 |
| Dexamethasone Block | Patient Satisfaction With Pain Control | 48 hours (n=42, 37, 41) | 8.4 units on a scale | Standard Deviation 2.2 |
| Dexamethasone Block | Patient Satisfaction With Pain Control | 24 hours (n=34, 28, 37) | 7.8 units on a scale | Standard Deviation 2.7 |
| Dexamethasone IV | Patient Satisfaction With Pain Control | 1 week (n=42, 36, 41) | 8.8 units on a scale | Standard Deviation 1.7 |
| Dexamethasone IV | Patient Satisfaction With Pain Control | 24 hours (n=34, 28, 37) | 7.9 units on a scale | Standard Deviation 2.6 |
| Dexamethasone IV | Patient Satisfaction With Pain Control | 48 hours (n=42, 37, 41) | 8.7 units on a scale | Standard Deviation 2 |
| Placebo | Patient Satisfaction With Pain Control | 48 hours (n=42, 37, 41) | 7.6 units on a scale | Standard Deviation 2.9 |
| Placebo | Patient Satisfaction With Pain Control | 24 hours (n=34, 28, 37) | 7.3 units on a scale | Standard Deviation 2.8 |
| Placebo | Patient Satisfaction With Pain Control | 1 week (n=42, 36, 41) | 8.4 units on a scale | Standard Deviation 2.4 |
Comparison: Comparison between the 3 groups for pain scores at 24 hours.p-value: 0.61Kruskal-Wallis
Comparison: Comparison between the 3 groups for pain scores at 48 hours.p-value: 0.13Kruskal-Wallis
Comparison: Comparison between the 3 groups for pain scores at 1 week.p-value: 0.25Kruskal-Wallis
Secondary
Post Operative Opioid Dose at 24 Hours
Time frame: approximately 24 hours after surgery
Population: The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Block | Post Operative Opioid Dose at 24 Hours | 12.2 mg morphine equivalents | Standard Deviation 9.3 |
| Dexamethasone IV | Post Operative Opioid Dose at 24 Hours | 17.1 mg morphine equivalents | Standard Deviation 15.9 |
| Placebo | Post Operative Opioid Dose at 24 Hours | 24.1 mg morphine equivalents | Standard Deviation 14.3 |
p-value: 0.001ANOVA
Secondary
Time Until First Dose of Analgesic
Time frame: Approximately 10 hours after surgery
Population: The number of participants analyzed is different from the number of participants in each arm who completed the trial because data were not available for 1 participant in the Dexamethasone IV group and 1 participant in the placebo group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone Block | Time Until First Dose of Analgesic | 8.4 hours | Standard Deviation 5.6 |
| Dexamethasone IV | Time Until First Dose of Analgesic | 9.2 hours | Standard Deviation 5.6 |
| Placebo | Time Until First Dose of Analgesic | 8.4 hours | Standard Deviation 4.8 |
p-value: 0.76ANOVA