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The Minimally Invasive Thoracic Surgery Intercostal Nerve Block Trial is a single center, double-blind, randomized, active-comparator controlled clinical trial to assess the analgesic efficacy of intercostal nerve block by Liposomal Bupivacaine versus Standard Bupivacaine in subjects undergoing lung resection by robotic or video-assisted thoracoscopic surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liposomal Bupivacaine | Experimental | 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. Drug Preparation: 266mg (20cc) Liposomal Bupivacaine admixed with 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) and varied 0.9% normal saline volume for total volume of 60cc. |
|
| Standard Bupivacaine | Active Comparator | 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. Drug Preparation - 0.25% (2.5mg/cc) Standard Bupivacaine (maximum dose of 2mg/kg) admixed with varied 0.9% normal saline volume for total volume of 60cc. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal bupivacaine | Drug | 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily In-Hospital Use of Opioids | Measured in Oral Morphine Equivalents per Day | Average over Entire Length of Hospitalization (Up to 1 Week) |
| Measure | Description | Time Frame |
|---|---|---|
| Average Daily In-Hospital Pain Score | Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain). | Average over Length of Hospitalization - Up to 1 Week |
| Number of Participants With Postoperative Pneumonia |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Liposomal Bupivacaine | Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. |
| FG001 | Standard Bupivacaine | Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Liposomal Bupivacaine | Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. |
| BG001 | Standard Bupivacaine | Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. |
| 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 | Average Daily In-Hospital Use of Opioids | Measured in Oral Morphine Equivalents per Day | Posted | Mean | Standard Deviation | Oral Morphine Equivalent per Day | Average over Entire Length of Hospitalization (Up to 1 Week) |
|
From time of drug administration to subsequent 30 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 | Liposomal Bupivacaine | Liposomal Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Greg J. Haro | University of California, San Francisco | 415-353-7502 | greg.haro@ucsf.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 | Nov 5, 2019 | Apr 13, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013896 | Thoracic Diseases |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D012140 | Respiratory Tract Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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Syringe with Obscuring Over-Wrap
| Bupivacaine Injection | Drug | 5cc of drug preparation will be percutaneously injected into each intercostal space 3-10 under direct intrathoracic vision and subcutaneously into each surgical wound at the conclusion of the surgery. |
|
Pneumonia (Y/N)
| Index Hospitalization following Surgery until Discharge - Up to 1 Week |
| Length of Stay | Measured in Days | Index Hospitalization following Surgery until Discharge - Up to 1 Week |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Smoker | Count of Participants | Participants |
|
| Primary Lung Cancer | Count of Participants | Participants |
|
| Robotic Surgery | Count of Participants | Participants |
|
| Sublobar Resection | Count of Participants | Participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Secondary | Average Daily In-Hospital Pain Score | Measured 0-10 Visual Analog Scale for Pain (Higher Score Means Worse Pain). | Posted | Mean | Standard Deviation | Units on a Scale | Average over Length of Hospitalization - Up to 1 Week |
|
|
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| Secondary | Number of Participants With Postoperative Pneumonia | Pneumonia (Y/N) | Posted | Count of Participants | Participants | Index Hospitalization following Surgery until Discharge - Up to 1 Week |
|
|
|
| Secondary | Length of Stay | Measured in Days | Posted | Mean | Standard Deviation | Days | Index Hospitalization following Surgery until Discharge - Up to 1 Week |
|
|
|
| 0 |
| 41 |
| 0 |
| 41 |
| 0 |
| 41 |
| EG001 | Standard Bupivacaine | Standard Bupivacaine: Drug percutaneously injected into intercostal spaces 3-10 under direct intrathoracic vision. | 0 | 39 | 0 | 39 | 0 | 39 |
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D000588 |
| Amines |