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Many patients undergoing ambulatory shoulder arthroscopy experience moderate to severe pain after surgery. Finding ways to minimize postoperative pain are ideal. Dexamethasone is a corticosteroid that is commonly used to prevent and/or treat nausea and inflammation. The addition of higher doses of dexamethasone to nerve blocks, which are injections of local anesthetics into the upper shoulder area, has been shown to prolong block duration and reduce pain. However, it is unclear whether the advantage of longer pain relief outweighs patient dissatisfaction with the prolonged feeling of a numb arm. Furthermore, recent studies have shown that systemic, intravenously administered dexamethasone may similarly reduce pain levels when compared with dexamethasone in the block. In our study, the investigators propose to examine the effect of low-dose IV versus block dexamethasone on interscalene block duration in patients undergoing shoulder arthroscopy. Most studies have used 4 mg or more. One study suggests that 1 mg may have the same effect as larger doses. Our aims are to determine whether the addition of low-dose dexamethasone to a local anesthetic in the block can prolong its duration, and whether there are differences in postoperative pain, consumption of painkillers, side effects, and satisfaction in patients who received IV or block dexamethasone. Patients (128 total) will be randomly assigned to either receive IV or block dexamethasone, and postoperative assessments (pain, painkiller use, side effects, block duration, satisfaction, complications) will be made via phone at 2, 3, 4 (if needed), and 7-10 days after surgery. Results from this study will reveal whether patients prefer the longer-duration analgesia that may be obtained with low-dose dexamethasone in the block.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous dexamethasone | Active Comparator | Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline. |
|
| Perineural dexamethasone | Experimental | Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bupivacaine | Drug |
| ||
| Perineural dexamethasone |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve Block Duration | Time at which the pain relief from the block has completely worn off | Postoperative day 2+ |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale Pain Scores | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Duration of stay in recovery room after surgery (average of 3 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Kahn | Hospital for Special Surgery, New York | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital for Special Surgery | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29889698 | Derived | Kahn RL, Cheng J, Gadulov Y, Fields KG, YaDeau JT, Gulotta LV. Perineural Low-Dose Dexamethasone Prolongs Interscalene Block Analgesia With Bupivacaine Compared With Systemic Dexamethasone: A Randomized Trial. Reg Anesth Pain Med. 2018 Aug;43(6):572-579. doi: 10.1097/AAP.0000000000000817. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Intravenous Dexamethasone | Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline. Bupivacaine Intravenous dexamethasone Perineural saline: Saline in nerve block |
| FG001 | Perineural Dexamethasone | Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone. Bupivacaine Perineural dexamethasone: Dexamethasone in nerve block Intravenous saline |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Intravenous Dexamethasone | Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline. Bupivacaine Intravenous dexamethasone Perineural saline: Saline in nerve block |
| BG001 | Perineural Dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Nerve Block Duration | Time at which the pain relief from the block has completely worn off | Posted | Median | Inter-Quartile Range | Hours | Postoperative day 2+ |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intravenous Dexamethasone | Patients will receive 1 cc (1 mg) dexamethasone intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc saline. Bupivacaine Intravenous dexamethasone Perineural saline: Saline in nerve block |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Richard Kahn | Hospital of Special Surgery | 212-774-7274 | KahnR@HSS.EDU |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Drug |
Dexamethasone in nerve block |
|
| Intravenous dexamethasone | Drug |
|
| Intravenous saline | Drug |
|
| Perineural saline | Drug | Saline in nerve block |
|
| Opioid Consumption |
| Postoperative day 2, postoperative day 3 |
| Side Effects | Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only. For each symptom, severity is assessed by the question: "(If yes), how severe was it usually?" (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4) | Postoperative day 2, postoperative day 3 |
| Block Satisfaction | 0-10 scale (0=not satisfied; 10=extremely satisfied) | Postoperative day 2, postoperative day 3 |
| Block-related Complications | Postoperative day 7-10 |
| % of Participants Who Guessed the Correct Group | Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group | Postoperative day 7-10 |
Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone. Bupivacaine Perineural dexamethasone: Dexamethasone in nerve block Intravenous saline |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Secondary | Numerical Rating Scale Pain Scores | The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable") | Posted | Median | Inter-Quartile Range | Units on a Scale | Duration of stay in recovery room after surgery (average of 3 hours) |
|
|
|
| Secondary | Opioid Consumption | Posted | Mean | Standard Deviation | mg | Postoperative day 2, postoperative day 3 |
|
|
|
| Secondary | Side Effects | Opioid-related symptom distress scale is calculated using responses to the symptom severity questions only. For each symptom, severity is assessed by the question: "(If yes), how severe was it usually?" (In the past 24 hours) The responses to the severity questions are measured on a 5-point scale from 0-4 in ascending order as follows: Did not have symptom (0) Slight (1) Moderate (2) Severe (3) Very severe (4) | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 2, postoperative day 3 |
|
|
|
| Secondary | Block Satisfaction | 0-10 scale (0=not satisfied; 10=extremely satisfied) | Posted | Mean | Standard Deviation | units on a scale | Postoperative day 2, postoperative day 3 |
|
|
|
| Secondary | Block-related Complications | Posted | Number | patients with block complications | Postoperative day 7-10 |
|
|
|
| Secondary | % of Participants Who Guessed the Correct Group | Patients will be asked whether they believe they were in the IV dexamethasone or intravenous dexamethasone group | Posted | Number | 95% Confidence Interval | % of participants | Postoperative day 7-10 |
|
|
|
| 0 |
| 62 |
| 0 |
| 62 |
| EG001 | Perineural Dexamethasone | Patients will receive 1 cc saline intravenously and a block containing 15 cc bupivacaine 0.5% and 1 cc (1 mg) dexamethasone. Bupivacaine Perineural dexamethasone: Dexamethasone in nerve block Intravenous saline | 0 | 63 | 0 | 63 |
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| D000588 |
| Amines |