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The purpose of this study is to compare the effect of liposomal Bupivacaine infiltration into the shoulder to continues nerve block with Bupivacaine on postoperative pain control and functional outcomes.
liposomal bupivacaine analgesia will provide improved postoperative pain control, reduction in amount of opioid supplementation, decreased complications and faster return to function compared to current standard of care pain management for patients undergoing shoulder arthroplasty and shoulder surgery for proximal humerus fractures.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine A | Experimental | One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty |
|
| CISB control for A | Active Comparator | Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty . |
|
| Liposomal Bupivacaine B | Experimental | One time injection of 1.3% Liposomal Bupivacaine during Humerus Fracture Fixation |
|
| CISB control for B | Active Comparator | Peripheral nerve block (CISB) with 0.125% bupivacaine during fracture fixation |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 1.3% Liposomal Bupivacaine | Drug | local tissue infiltration of Liposomal Bupivacaine during surgery |
|
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Analgesia | Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Post Operative American Shoulder and Elbow Surgeons (ASES) | American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wayne State University Physician Group | Dearborn | Michigan | 48124 | United States |
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This prospective, randomized, controlled study included 70 consecutive shoulder arthroplasty patients from August 2015 through June 2016 during the period of 1 year at one location.
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine A | One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty 1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery |
| FG001 | CISB Control for A | Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty . 0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine A | One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty 1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery |
| BG001 | CISB Control for A |
| 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 | Quality of Analgesia | Quality of analgesia as measured by numerical rating scores for pain (active and at rest) as (0=no pain, 10= worst pain) every two hours for the initial 36 hours, then on day2, day7 and day30 postoperatively | Posted | Mean | Full Range | score on a scale | 30 days |
|
Three months
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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 A | One time injection of 1.3% Liposomal Bupivacaine during shoulder arthroplasty 1.3% Liposomal Bupivacaine: local tissue infiltration of Liposomal Bupivacaine during surgery |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| COPD | Respiratory, thoracic and mediastinal disorders | Systematic Assessment | Respiratory insufficiency in a chronic obstructive pulmonary disease and sleep apnea |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vani J. Sabesan, MD | Wayne State University School of Medicine and Cleveland Clinic Florida | 131375138489 | sabes001@gmail.com |
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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 | Apr 14, 2015 | Jan 27, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| 0.125% Bupivacaine | Drug | Continues nerve block with Bupivacaine during surgery and postoperatively |
|
|
| Preoperative, 6 weeks and last follow up |
| Subjective Shoulder Value (SSV) | Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100% | Pre-operative, 6 weeks and last Follow up |
| Incidence of Nerve Injury | Neuropraxia on the treatment side | During hospital stay and at 2 weeks and 6 weeks post-operatively |
| Post Operative Opioid Consumption | Cumulative amount of opioids administered during the time frame | During hospital stay up to 48 hours after surgery |
Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty .
0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively
| BG002 | Total | Total of all reporting groups |
| Participants |
| No |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Surgical Side | Count of Participants | Participants | No |
|
| Arthroplasty type | Number | participants |
|
|
|
| Secondary | Post Operative American Shoulder and Elbow Surgeons (ASES) | American Shoulder and Elbow Surgeons (ASES) score is an outcome reporting measure for assessments of shoulder function in patients with shoulder pathology and after shoulder arthroplasty surgery. ASES is a 100 points scale consisting of two measures: one pain scale (worth 50 points) and 10 activities of daily living(worth 50 points), the total score is the sum of both and the higher total score indicates better outcome. | Posted | Mean | Standard Deviation | score on a scale | Preoperative, 6 weeks and last follow up |
|
|
|
| Secondary | Subjective Shoulder Value (SSV) | Functional assessments after shoulder arthroplasty surgery. The SSV is defined as a patient's subjective shoulder assessment expressed as a percentage of an entirely normal shoulder, which would score 100%. The range is between 0% and 100% | Posted | Mean | Full Range | score on a scale | Pre-operative, 6 weeks and last Follow up |
|
|
|
| Secondary | Incidence of Nerve Injury | Neuropraxia on the treatment side | Posted | Count of Participants | Participants | During hospital stay and at 2 weeks and 6 weeks post-operatively |
|
|
|
| Secondary | Post Operative Opioid Consumption | Cumulative amount of opioids administered during the time frame | Posted | Number | Total MME per Group | During hospital stay up to 48 hours after surgery |
|
|
|
| 0 |
| 34 |
| 1 |
| 34 |
| 1 |
| 34 |
| EG001 | CISB Control for A | Peripheral nerve block (CISB) with 0.125% bupivacaine during shoulder arthroplasty . 0.125% Bupivacaine: Continues nerve block with Bupivacaine during surgery and postoperatively | 0 | 36 | 0 | 36 | 7 | 36 |
|
| catheter malposition | Injury, poisoning and procedural complications | Systematic Assessment | Residual numbness of the hand and neck |
|
| Catheter fall out | Injury, poisoning and procedural complications | Systematic Assessment |
|
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| D000588 |
| Amines |
| Last Followup |
|
| At last follow up |
|