Shoulder Pain
Conditions
Keywords
Total Shoulder Arthroplasty (TSA), Interscalene Nerve Block (ISB)
Brief summary
This is a phase IV , randomized, single-blind, single-center study comparing patient related outcomes such as postoperative pain and opioid usage for patients who receive ISB 's containing liposomal bupivacaine (Exparel®) plus 0.5% bupivacaine HCL versus 0.5% bupivacaine HCL undergoing total shoulder arthroplasty. The objective of this study is to compare opioid utilization and pain management of patients who receive Exparel in an ISB vs standard 0.5% bupivacaine HCL during the initial 72 --- hour post --- operative period. Additionally, to understand the duration of block after addition of Exparel® to bupivacaine in an Interscalene block after TSA.
Interventions
DRUGLiposomal Bupivacaine
Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL
0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB)
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* Patients undergoing total shoulder arthroplasty; * Patients who consent to be randomized.
Exclusion criteria
* Patients younger than 18 and older than 75; * Patients with a history of chronic pain that have used opioids for pain management for 3 months or longer; * Patients who are allergic to oxycodone; * Patients who are unable to speak English; * Patients with diagnosed or self---reported cognitive dysfunction; * Patients with a history of neurologic disorder that can interfere with pain sensation; * Patients with a history of drug or recorded alcohol abuse; * Patients who are unable to understand or follow instructions; * Patients with severe liver disease, renal insufficiency, congestive heart failure, and/or significant heart disease; * Patients with an allergy or contraindication to any of the medications used in the study, or patients with a contraindication to any study procedures; * Patients with BMI over 40; * Any patient that the investigators feel cannot comply with all study related procedures; * NYU Langone Health students, residents, faculty or staff members
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Utilization | 24-72 hour, Post-Operative Period | Measure in morphine milligram equivalents \[MME\] |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Opioid Utilization | Day 4-7, Post-Operative Period | Measure in morphine milligram equivalents \[MME\] |
| Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | Day 1-7, Post-Operative Period | PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5. 1. = No pain 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe |
| T-Scores, PROMIS Pain Intensity Scale | Day 1-7, Post-Operative Period | PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 20 mL 0.5% Bupivacaine HCL 0.5% Bupivacaine HCL: 0.5% Bupivacaine HCL for Interscalene Nerve Block (ISB) | 72 |
| Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% Administered in an Interscalene block for TSA
Liposomal Bupivacaine: Liposomal Bupivacaine Plus 0.5% Bupivacaine HCL | 78 |
| Total | 150 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Chronic pain/history of substance abuse | 1 | 1 |
| Overall Study | Lost to Follow-up | 18 | 11 |
| Overall Study | Required additional meds/surgery | 1 | 2 |
Baseline characteristics
| Characteristic | 20 mL 0.5% Bupivacaine HCL | Total | Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% |
|---|---|---|---|
| Age, Continuous | 66.39 years STANDARD_DEVIATION 8.77 | 67.63 years STANDARD_DEVIATION 8.8 | 68.87 years STANDARD_DEVIATION 8.83 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 7 Participants | 16 Participants | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 65 Participants | 134 Participants | 69 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 7 Participants | 16 Participants | 9 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 13 Participants | 8 Participants |
| Race (NIH/OMB) White | 60 Participants | 121 Participants | 61 Participants |
| Region of Enrollment United States | 72 participants | 150 participants | 78 participants |
| Sex: Female, Male Female | 30 Participants | 69 Participants | 39 Participants |
| Sex: Female, Male Male | 42 Participants | 81 Participants | 39 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 72 | 0 / 78 |
| other Total, other adverse events | 2 / 72 | 5 / 78 |
| serious Total, serious adverse events | 0 / 72 | 0 / 78 |
Outcome results
Primary
Opioid Utilization
Measure in morphine milligram equivalents \[MME\]
Time frame: 24-72 hour, Post-Operative Period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mL 0.5% Bupivacaine HCL | Opioid Utilization | 54.79 Morphine Milligram Equivalents (MME) | Standard Deviation 15.26 |
| Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Opioid Utilization | 30.38 Morphine Milligram Equivalents (MME) | Standard Deviation 11.62 |
Secondary
Opioid Utilization
Measure in morphine milligram equivalents \[MME\]
Time frame: Day 4-7, Post-Operative Period
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mL 0.5% Bupivacaine HCL | Opioid Utilization | 36.44 Morphine Milligram Equivalents (MME) | Standard Deviation 11.13 |
| Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Opioid Utilization | 18.73 Morphine Milligram Equivalents (MME) | Standard Deviation 7.55 |
Secondary
Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale
PROMIS Pain Intensity surveys are made up of three pain intensity questions, on a scale of 1-5. 1. = No pain 2. = Mild 3. = Moderate 4. = Severe 5. = Very Severe
Time frame: Day 1-7, Post-Operative Period
Population: The sample size is slightly smaller because this data was not collected at the beginning of the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 20 mL 0.5% Bupivacaine HCL | Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | In the past 7 days, how intense was your pain at its worst? | 3.7 score on a scale | Standard Deviation 1.16 |
| 20 mL 0.5% Bupivacaine HCL | Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | In the past 7 days, how intense was your average pain? | 2.81 score on a scale | Standard Deviation 1.2 |
| 20 mL 0.5% Bupivacaine HCL | Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | What is your level of pain right now? | 2.22 score on a scale | Standard Deviation 1.16 |
| Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | In the past 7 days, how intense was your pain at its worst? | 3.07 score on a scale | Standard Deviation 1.02 |
| Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | In the past 7 days, how intense was your average pain? | 2.39 score on a scale | Standard Deviation 1 |
| Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | Score on Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Intensity Scale | What is your level of pain right now? | 1.83 score on a scale | Standard Deviation 1.02 |
Secondary
T-Scores, PROMIS Pain Intensity Scale
PROMIS Pain Intensity surveys are made up of three pain questions, which generate T-scores. T-scores are standard scores with a mean of 50 and standard deviation of 10 in a reference population.
Time frame: Day 1-7, Post-Operative Period
Population: The sample size is slightly smaller because this data was not collected at the beginning of the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 20 mL 0.5% Bupivacaine HCL | T-Scores, PROMIS Pain Intensity Scale | 46.48 T-Score | Standard Deviation 7.6 |
| Interscalene Nerve Block With Liposomal + Bupivacaine 0.5% | T-Scores, PROMIS Pain Intensity Scale | 50.8 T-Score | Standard Deviation 7.4 |