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In this study, patients receiving shoulder arthroscopy will receive an interscalene block for pain management containing either liposomal bupivacaine and standard bupivacaine or standard bupivacaine and dexamethasone. Patients will be followed up with to determine postoperative pain and block duration.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal bupivacaine & standard bupivacaine | Experimental |
| |
| Standard bupivacaine & dexamethasone | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel 133 MG Per 10 ML Injection | Drug | 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours | NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome. | First 72 hours pain |
| Measure | Description | Time Frame |
|---|---|---|
| Numerical Rating Scale (NRS) Pain at Rest | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome. | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Kim, MD | 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 |
Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures and appendices).
Beginning 3 months and ending 5 years following article publication
Researchers who provide a methodologically sound proposal
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine & Standard Bupivacaine | Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) |
| FG001 | Standard Bupivacaine & Dexamethasone | Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine & Standard Bupivacaine | Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) |
| BG001 | Standard Bupivacaine & Dexamethasone |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Numerical Rating Scale (NRS) Pain at Rest Over 72 Hours | NRS pain at rest averaged over the first 72 hours. NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable). Patient reported pain at 24, 48, and 72 hours are averaged to produce this number. Lower score is a better outcome. | Posted | Mean | Standard Deviation | score on a scale | First 72 hours pain |
|
Up to 14 days following surgery
At Risk patients for the Liposomal Bupivacaine group were 55 in count. However, due to lost to follow up, 43 of the 55 patients were analyzed for POD7-POD 14. At Risk patients for the Dexamethasone ISB group were 56 in count. However, due to lost to follow up, only 42 patients were able to be analyzed for POD7-POD14.
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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 | Liposomal Bupivacaine & Standard Bupivacaine | Exparel 133 MG Per 10 ML Injection: 10mL of 133mg liposomal bupivacaine with 5mL of 0.5% bupivacaine (15mL total) |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Postoperative neurologic symptoms at 7 days after surgery | Nervous system disorders | Non-systematic Assessment | Includes the presence of one or multiple: numbness, tingling, weakness, stiffness, or coldness of hand and/or finger tips, wrist, elbow, arm. Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David H. Kim | Hospital for Special Surgery | 212-606-1036 | kimd@hss.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 28, 2021 | May 12, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D020069 | Shoulder Pain |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
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| ID | Term |
|---|---|
| D007267 | Injections |
| D003907 | Dexamethasone |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D011246 | Pregnadienetriols |
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|
| Dexamethasone | Drug | 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected |
|
| Numerical Rating Scale (NRS) Pain With Movement | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome. | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
| Opioid Consumption | Opioid consumption, measured in oral morphine equivalents | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
| Patient Satisfaction With Pain Management: Scale | Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
| Brief Pain Inventory Short-form | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life. | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
| Duration of Analgesic Block | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration. | 24, 48, 72, 96 (if needed) hours postoperatively |
| Sensory Resolution | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. | 24, 48, 72, 96 (if needed) hours postoperatively |
| Motor Block Resolution | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. | 24, 48, 72, 96 (if needed) hours postoperatively |
| Time to Readiness for Discharge | Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System. | Postanesthesia care unit (0-6 hours postoperative) |
| Postanesthesia Care Unit Length of Stay | Total length of PACU stay as defined by time of PACU admission to PACU discharge. | Postanesthesia care unit (0-6 hours postoperative) |
Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| American Society of Anesthesiology Status | The ASA Physical Status Classification System has been in use for over 60 years. The purpose of the system is to assess and communicate a patient's pre-anesthesia medical co-morbidities. Participants were graded by anesthesiologists pre surgery. The lower the level, the healthier the patient. | Count of Participants | Participants |
|
| Body Mass Index, kg/m^2 | Mean | Standard Deviation | Kg/m^2 |
|
|
|
| Secondary | Numerical Rating Scale (NRS) Pain at Rest | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain at rest. Lower score is a better outcome. | Posted | Mean | Standard Deviation | score on a scale | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
|
|
|
| Secondary | Numerical Rating Scale (NRS) Pain With Movement | NRS pain is on a scale from 0 (no pain at all) to 10 (worst pain imaginable) and is patient reported for pain with movement. Lower score means better outcome. | Posted | Mean | Standard Deviation | score on a scale | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
|
|
|
| Secondary | Opioid Consumption | Opioid consumption, measured in oral morphine equivalents | Posted | Mean | Standard Deviation | Oral Morphine Equivalents (mg) | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
|
|
|
| Secondary | Patient Satisfaction With Pain Management: Scale | Patient reported satisfaction on a scale of 0 (not satisfied) to 10 (complete satisfaction). This is patient opinionated and is reflective with patient contentedness with their pain management. Higher scores indicate greater satisfaction | Posted | Mean | Standard Deviation | score on a scale | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
|
|
|
| Secondary | Brief Pain Inventory Short-form | The Brief Pain Inventory (BPI) rapidly assesses the severity of pain and its impact on functioning. Higher scores indicate more pain. The minimum value is 0, the maximum value is 10. A lower score is a better outcome. This score is an average of the following measures on a 0-10 scale: General activity, Mood, Walking ability, Normal work, Relations to People, Sleep Quality, and Enjoyment of life. | Posted | Mean | Standard Deviation | score on a scale | Postanesthesia care unit (up to 6 hours postoperative), postoperative day 1, postoperative day 2, postoperative day 3, postoperative day 4, postoperative day 7 |
|
|
|
| Secondary | Duration of Analgesic Block | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. Patients are asked "When did your pain relief from the block completely wear off?" This indicates the block duration. | Posted | Median | Inter-Quartile Range | Hours | 24, 48, 72, 96 (if needed) hours postoperatively |
|
|
|
| Secondary | Sensory Resolution | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. | Posted | Median | Inter-Quartile Range | Hours | 24, 48, 72, 96 (if needed) hours postoperatively |
|
|
|
| Secondary | Motor Block Resolution | Patients are contacted and asked questions regarding their motor strength and sensation in their shoulder. | Posted | Median | Inter-Quartile Range | Hours | 24, 48, 72, 96 (if needed) hours postoperatively |
|
|
|
| Secondary | Time to Readiness for Discharge | Time to readiness for PACU discharge was evaluated every 15min using the Post Anesthetic Discharge Scoring System. | Posted | Median | Inter-Quartile Range | minutes | Postanesthesia care unit (0-6 hours postoperative) |
|
|
|
| Secondary | Postanesthesia Care Unit Length of Stay | Total length of PACU stay as defined by time of PACU admission to PACU discharge. | Posted | Median | Inter-Quartile Range | minutes | Postanesthesia care unit (0-6 hours postoperative) |
|
|
|
| 0 |
| 55 |
| 0 |
| 55 |
| 6 |
| 55 |
| EG001 | Standard Bupivacaine & Dexamethasone | Dexamethasone: 15mL of 0.5% bupivacaine with 4mg of preservative-free dexamethasone will be injected | 0 | 56 | 0 | 56 | 3 | 56 |
|
| Postoperative neurologic symptoms at 14 days after surgery | Nervous system disorders | Non-systematic Assessment | Includes the presence of one or multiple: numbness, tingling, weakness, stiffness, or coldness of hand and/or finger tips, wrist, elbow, arm. Events were monitored/assessed in such a manner that the specific Adverse Event Terms cannot be separated |
|
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011245 |
| Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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