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PI decision to close study early
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The purpose of this study is to collect information about how patients feel when doctors manage their pain after lumbar spine surgery using a combination of EXPAREL® and bupivacaine injected into the lumbar spine at the end of surgery, compared to the patients that doctors use only EXPAREL® or bupivacaine to manage their pain. This information will help doctors determine which approach works best for patients who will receive surgery in their lumbar spine in the future.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Local infiltration of EXPAREL and Bupivacaine | Active Comparator |
| |
| Local infiltration of Exparel | Active Comparator |
| |
| Local infiltration of Bupivacaine | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exparel | Drug | 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean Postoperative Pain Score | Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain | last day of hospitalization, average of 3 days in hospital |
| Measure | Description | Time Frame |
|---|---|---|
| Total Consumption of Opioids During Hospital Stay | All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids | last day of hospitalization, average of 3 days in hospital |
| Mean Time to Achieve Physical Therapy Discharge |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert Greenleaf, MD | Princpal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Virtua Memorial Hospital | Mount Holly | New Jersey | 08060 | United States |
Publish research findings in relevant peer-reviewed journal
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| ID | Title | Description |
|---|---|---|
| FG000 | Local Infiltration of EXPAREL and Bupivacaine | Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution |
| FG001 | Local Infiltration of Exparel |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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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 | Oct 13, 2016 |
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| Bupivacaine | Drug | 30 mL bupivacaine 0.5% w/v solution |
|
Mean time to achieve physical therapy discharge criteria |
| last day of hospitalization, average of 3 days in hospital |
| Number of Participants With Opioid Related Adverse Events | Number of Participants with Opioid Related Adverse Events | last day of hospitalization, average of 3 days in hospital |
Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL
| FG002 | Local Infiltration of Bupivacaine | Bupivacaine: 30 mL bupivacaine 0.5% w/v solution |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Local Infiltration of EXPAREL and Bupivacaine | Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution |
| BG001 | Local Infiltration of Exparel | Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL |
| BG002 | Local Infiltration of Bupivacaine | Bupivacaine: 30 mL bupivacaine 0.5% w/v solution |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
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| 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 | Mean Postoperative Pain Score | Wong-Baker pain faces scale of 0-no pain, to 10-extreme pain | Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group | Posted | Mean | Full Range | units on a scale | last day of hospitalization, average of 3 days in hospital |
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| Secondary | Total Consumption of Opioids During Hospital Stay | All opioid analgesics will be converted into oral mg morphine equivalent to determine the total dose of opioids | Data is not collected for one patient in the Local infiltration of EXPAREL and Bupivacaine group | Posted | Mean | Full Range | milligram | last day of hospitalization, average of 3 days in hospital |
|
| ||||||||||||||||||||||||||||||||
| Secondary | Mean Time to Achieve Physical Therapy Discharge | Mean time to achieve physical therapy discharge criteria | This data was not collected | Posted | last day of hospitalization, average of 3 days in hospital |
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| Secondary | Number of Participants With Opioid Related Adverse Events | Number of Participants with Opioid Related Adverse Events | Posted | Count of Participants | Participants | last day of hospitalization, average of 3 days in hospital |
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Duration of patient's hospital stay, an average of three days
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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 | Local Infiltration of EXPAREL and Bupivacaine | Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL Bupivacaine: 30 mL bupivacaine 0.5% w/v solution | 0 | 11 | 0 | 11 | 1 | 11 |
| EG001 | Local Infiltration of Exparel | Exparel: 1 level patients - 20 mL Exparel; 2 level patients - 20 mL Exparel diluted to 40 mL | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Local Infiltration of Bupivacaine | Bupivacaine: 30 mL bupivacaine 0.5% w/v solution | 0 | 4 | 0 | 4 | 1 | 4 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoxia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
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| Nausea | Gastrointestinal disorders | Non-systematic Assessment |
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| lethargy | General disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment |
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| Unsteadiness | General disorders | Non-systematic Assessment |
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| Urinary retention | Renal and urinary disorders | Non-systematic Assessment |
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| Constitpation | Gastrointestinal disorders | Non-systematic Assessment |
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Early termination leading to small numbers of subjects analyzed
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Robert Greenleaf | Reconstructive Orthopedics | 609-267-9400 | bob.greenleaf1@gmail.com |
| Dec 10, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D055959 | Intervertebral Disc Degeneration |
| D007405 | Intervertebral Disc Displacement |
| D003251 | Constriction, Pathologic |
| D013168 | Spondylolisthesis |
| D013169 | Spondylolysis |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D055009 | Spondylosis |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
| D000588 | Amines |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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