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The purpose of this study is to determine which medication(s) should be included in the interscalene nerve block (an injection of local anesthetic [numbing medicine] near nerves in the shoulder) for patients undergoing total shoulder arthroplasty (shoulder replacement). The ideal nerve block would reduce pain after shoulder surgery without causing a great deal of muscle weakness.
All patients will receive an intravenous pain pump (patient-controlled analgesia) and a nerve block with long-lasting local anesthetic. The three study groups will receive additives (clonidine, dexamethasone, buprenorphine plus local anesthetic) in the nerve block that may reduce postoperative pain. One of the study groups uses the usual concentration of local anesthetic, while the other two study groups use reduced concentrations of local anesthetic. Follow-up with study patients begins on the day of surgery and continues through postoperative day 2. Seen twice daily, patients will be asked about their pain and assessed for sensory function and strength of their shoulder muscle and hand grip.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Interscalene Block (ISB) - 0.375% Ropivacaine + additives | Active Comparator |
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| Interscalene Block (ISB) - 0.2% Ropivacaine + additives | Active Comparator |
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| Interscalene Block (ISB) - 0.1% Ropivacaine + additives | Active Comparator |
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| Interscalene Block (ISB) - Systemic Control | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interscalene Block (ISB) - 0.375% Ropivacaine + additives | Procedure | Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline |
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score With Movement | Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain) | 24 hours after the interscalene block is given |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of Analgesia From Interscalene Nerve Block | Median time until a patient needed to take opioid pain medication | Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM |
| Numeric Rating Scale (NRS) Pain Scores at Rest |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jacques T YaDeau, MD, PhD | 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 |
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| ID | Title | Description |
|---|---|---|
| FG000 | High Dose | Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline |
| FG001 | Medium Dose |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Interscalene Block (ISB) - 0.2% Ropivacaine + additives | Procedure | Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline |
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| Interscalene Block (ISB) - 0.1% Ropivacaine + additives | Procedure | Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline |
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| Interscalene Block (ISB) - Systemic Control | Procedure | Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg) |
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Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest
| Preop |
| Middle Deltoid | A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer | 24 hours after surgery |
Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline |
| FG002 | Low Dose | Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline |
| FG003 | Control | Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg) |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | High Dose | Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline |
| BG001 | Medium Dose | Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline |
| BG002 | Low Dose | Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline |
| BG003 | Control | Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg) |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| BMI | Mean | Standard Deviation | kg/m^2 |
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| 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 | |||||||||||||||||||||||||||||
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| Primary | Numeric Rating Scale (NRS) Pain Score With Movement | Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain) | Posted | Mean | Standard Deviation | units on a scale | 24 hours after the interscalene block is given |
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| Secondary | Duration of Analgesia From Interscalene Nerve Block | Median time until a patient needed to take opioid pain medication | Patients who were able to provide actual or estimates of time until they first needed to use pain medication were included in this analysis. | Posted | Mean | Standard Error | hours | Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM |
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| Secondary | Numeric Rating Scale (NRS) Pain Scores at Rest | Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest | Posted | Median | Inter-Quartile Range | units on a scale | Preop |
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| Secondary | Middle Deltoid | A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer | Patients who agreed to the measurements were included in the analysis. | Posted | Median | Inter-Quartile Range | kgf | 24 hours after surgery |
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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 | High Dose | Interscalene Block (ISB) - 0.375% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.375% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous (IV): saline | 0 | 20 | 0 | 20 | ||
| EG001 | Medium Dose | Interscalene Block (ISB) - 0.2% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.2% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline | 0 | 20 | 0 | 20 | ||
| EG002 | Low Dose | Interscalene Block (ISB) - 0.1% Ropivacaine + additives: Ultrasound-guided single-injection ISB: ropivacaine 0.1% + (clonidine [100 mcg] + dexamethasone [4 mg] + buprenorphine [150 mcg]); Intravenous: saline | 0 | 20 | 0 | 20 | ||
| EG003 | Control | Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg) | 0 | 20 | 0 | 20 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jacques YaDeau | Hospital for Special Surgery | 212774224 | yadeauj@hss.edu |
| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Control |
Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg) |
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Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg) |
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