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feasibility
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The purpose of this study is to determine whether the use of plain bupivacaine with common adjuvants for interscalene block (ISB) provides non-inferior analgesic results compared to the use of liposomal bupivacaine for ISB, in patients undergoing total shoulder arthroplasty.
The primary objective of this clinical study is to evaluate the comparative efficacy of interscalene block (ISB) using plain bupivacaine with adjuvants vs. liposomal bupivacaine on mean postoperative pain levels in patients who have undergone a total shoulder arthroplasty within the first 48 hours. Principal Investigators hypothesize that ISB using plain bupivacaine with adjuvants will provide similar pain relief as ISB using liposomal bupivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine Interscalene brachial plexus (ISB) | Active Comparator |
| |
| Bupivacaine with adjuvants ISB | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Pain Scores for the First 48 Hours | Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome. | At 48 hours postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative Opioid Consumption for the First 48 Hours | Morphine milligram equivalents (MME) over a 48 hour period | up to 48 hours |
| Satisfaction With Surgical Experience | Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Doug Jaffe, DO | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27732710 | Background | Sakamoto B, Keiser S, Meldrum R, Harker G, Freese A. Efficacy of Liposomal Bupivacaine Infiltration on the Management of Total Knee Arthroplasty. JAMA Surg. 2017 Jan 1;152(1):90-95. doi: 10.1001/jamasurg.2016.3474. | |
| 28146271 | Background | Hamilton TW, Athanassoglou V, Mellon S, Strickland LH, Trivella M, Murray D, Pandit HG. Liposomal bupivacaine infiltration at the surgical site for the management of postoperative pain. Cochrane Database Syst Rev. 2017 Feb 1;2(2):CD011419. doi: 10.1002/14651858.CD011419.pub2. |
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Will be shared upon request: raw data and statistical calculations
Available after study conclusion, for up to 3 years afterward.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine ISB | Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine) |
| FG001 | Bupivacaine With Adjuvants ISB | Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine ISB | Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine) |
| BG001 | Bupivacaine With Adjuvants ISB |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Average Pain Scores for the First 48 Hours | Pain levels will be measured by the mean Visual Analogue Scale- Numeric Rating Scale (VAS-NRS). The VAS-NRS is an 11 point scale with 0 (no pain) to 10 (worst possible pain). Higher scores denote worse outcome. | The software interface in this website will not allow for AUC as an acceptable outcome to satisfy field entries. Therefore, here the AUC is not reported here, but rather then mean and standard deviation are reported. | Posted | Mean | Standard Deviation | units on a scale | At 48 hours postoperatively |
|
24 hours
events that occurred during first 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 | Liposomal Bupivacaine ISB | Liposomal bupivacaine: Interscalene brachial plexus blockade using liposomal bupivacaine (expanded with plain bupivacaine) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jonathan Doug Jaffe DO | Wake Forest School of Medicine | 336-716-4498 | jjaffe@wakehealth.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 | Jun 9, 2020 | Sep 25, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2022 | Nov 1, 2022 | ICF_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 |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine with adjuvants | Drug | Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone. |
|
| at 48 hours |
| 29787389 | Background | Pichler L, Poeran J, Zubizarreta N, Cozowicz C, Sun EC, Mazumdar M, Memtsoudis SG. Liposomal Bupivacaine Does Not Reduce Inpatient Opioid Prescription or Related Complications after Knee Arthroplasty: A Database Analysis. Anesthesiology. 2018 Oct;129(4):689-699. doi: 10.1097/ALN.0000000000002267. |
| 27558150 | Background | Hamilton TW, Athanassoglou V, Trivella M, Strickland LH, Mellon S, Murray D, Pandit HG. Liposomal bupivacaine peripheral nerve block for the management of postoperative pain. Cochrane Database Syst Rev. 2016 Aug 25;2016(8):CD011476. doi: 10.1002/14651858.CD011476.pub2. |
| Background | Rabin T. FDA In Brief: FDA approves new use of Exparel for nerve block pain relief following shoulder surgeries. |
Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone.
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone. |
|
|
|
| Secondary | Postoperative Opioid Consumption for the First 48 Hours | Morphine milligram equivalents (MME) over a 48 hour period | Posted | Mean | Standard Deviation | Morphine milligram equivalents (MME) | up to 48 hours |
|
|
|
| Secondary | Satisfaction With Surgical Experience | Satisfaction scale is from 1-5, with the higher score being highest level of satisfaction | Posted | Mean | Standard Deviation | units on a scale | at 48 hours |
|
|
|
| 0 |
| 12 |
| 0 |
| 12 |
| 0 |
| 12 |
| EG001 | Bupivacaine With Adjuvants ISB | Bupivacaine with adjuvants: Interscalene brachial plexus blockade using plain bupivacaine with adjuvants: clonidine, epinephrine, buprenorphine, dexamethasone. | 0 | 13 | 0 | 13 | 0 | 13 |
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| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |