Total Shoulder Arthroplasty
Conditions
Brief summary
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.
Detailed description
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.
Interventions
PROCEDUREInterscalene 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
PROCEDUREInterscalene 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
PROCEDUREInterscalene 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
PROCEDUREInterscalene Block (ISB) - Systemic Control
Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg)
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients with osteoarthritis * Primary total shoulder arthroplasty * Age 18 to 80 years old * Planned use of general anesthesia * Planned use of a brachial plexus nerve block for postoperative analgesia * Ability to follow study protocol
Exclusion criteria
* Patients younger than 18 years old and older than 80 * Allergy or intolerance to one of the study medications * Patients with an American Society of Anesthesiologists (ASA) physical status of IV * Patients with insulin-dependent diabetes * Patients with hepatic (liver) failure * Patients with chronic renal (kidney) failure * Bradycardia (heart rate \< 50) or hypotension (systolic blood pressure \< 90 mmHg) * Chronic opioid use (taking opioids for longer than 3 months) (or active diagnosis of complex regional pain syndrome \[CRPS\]/reflex sympathetic dystrophy \[RSD\]) * Lack of English fluency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Numeric Rating Scale (NRS) Pain Score With Movement | 24 hours after the interscalene block is given | Pain with movement at 24 hours from the nerve block (scale of 0-10; 0 = no pain, 10 = worst possible pain) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Analgesia From Interscalene Nerve Block | Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM | Median time until a patient needed to take opioid pain medication |
| Numeric Rating Scale (NRS) Pain Scores at Rest | Preop | Assessment of NRS pain scores (scale of 0-10; 0 = no pain, 10 = worst possible pain) at rest |
| Middle Deltoid | 24 hours after surgery | A physical assessment will be done to determine the strength of the middle deltoid muscle in the operative arm using a dynamometer |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 20 |
| 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 | 20 |
| 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 | 20 |
| Control Interscalene Block (ISB) - Systemic Control: Ultrasound-guided single-injection ISB: ropivacaine 0.375%; Intravenous: clonidine (100 mcg) + dexamethasone (4 mg) + buprenorphine (150 mcg) | 20 |
| Total | 80 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Protocol Violation | 0 | 0 | 0 | 1 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | High Dose | Medium Dose | Low Dose | Control | Total |
|---|---|---|---|---|---|
| Age, Continuous | 66 years STANDARD_DEVIATION 8 | 64 years STANDARD_DEVIATION 9 | 69 years STANDARD_DEVIATION 7 | 68 years STANDARD_DEVIATION 7 | 67 years STANDARD_DEVIATION 7 |
| BMI | 28 kg/m^2 STANDARD_DEVIATION 4 | 25 kg/m^2 STANDARD_DEVIATION 3 | 27 kg/m^2 STANDARD_DEVIATION 4 | 31 kg/m^2 STANDARD_DEVIATION 6 | 28 kg/m^2 STANDARD_DEVIATION 5 |
| Region of Enrollment United States | 20 participants | 20 participants | 20 participants | 20 participants | 80 participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 15 Participants | 10 Participants | 47 Participants |
| Sex: Female, Male Male | 7 Participants | 11 Participants | 5 Participants | 10 Participants | 33 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 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 20 | 0 / 20 |
Outcome results
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)
Time frame: 24 hours after the interscalene block is given
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose | Numeric Rating Scale (NRS) Pain Score With Movement | 4.5 units on a scale | Standard Deviation 3 |
| Medium Dose | Numeric Rating Scale (NRS) Pain Score With Movement | 3.4 units on a scale | Standard Deviation 1.8 |
| Low Dose | Numeric Rating Scale (NRS) Pain Score With Movement | 4.2 units on a scale | Standard Deviation 2.4 |
| Control | Numeric Rating Scale (NRS) Pain Score With Movement | 4.9 units on a scale | Standard Deviation 2.5 |
Secondary
Duration of Analgesia From Interscalene Nerve Block
Median time until a patient needed to take opioid pain medication
Time frame: Postoperative day 1 at 8AM & 5PM, postoperative day 2 at 8AM & 5PM
Population: Patients who were able to provide actual or estimates of time until they first needed to use pain medication were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| High Dose | Duration of Analgesia From Interscalene Nerve Block | 21.3 hours | Standard Error 1 |
| Medium Dose | Duration of Analgesia From Interscalene Nerve Block | 16.8 hours | Standard Error 1.6 |
| Low Dose | Duration of Analgesia From Interscalene Nerve Block | 18.2 hours | Standard Error 1.9 |
| Control | Duration of Analgesia From Interscalene Nerve Block | 16.4 hours | Standard Error 1.4 |
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
Time frame: 24 hours after surgery
Population: Patients who agreed to the measurements were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Dose | Middle Deltoid | 2.8 kgf |
| Medium Dose | Middle Deltoid | 1.5 kgf |
| Low Dose | Middle Deltoid | 2.2 kgf |
| Control | Middle Deltoid | 1.8 kgf |
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
Time frame: Preop
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| High Dose | Numeric Rating Scale (NRS) Pain Scores at Rest | 3.0 units on a scale |
| Medium Dose | Numeric Rating Scale (NRS) Pain Scores at Rest | 3.2 units on a scale |
| Low Dose | Numeric Rating Scale (NRS) Pain Scores at Rest | 3.0 units on a scale |
| Control | Numeric Rating Scale (NRS) Pain Scores at Rest | 4.9 units on a scale |