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| Name | Class |
|---|---|
| Mednax National Medical Group | UNKNOWN |
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This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.
Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.
Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.
It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.
Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exparel | Experimental | Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. |
|
| 0.25% standard bupivicaine | Active Comparator | Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Liposomal Bupivicaine | Drug | 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 | Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets. | Assessed daily for 7 days post-procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Scores on a Analog Pain Scale (7 Days) | Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. | Assessed at day 7 post-procedure |
| Scores on an Analog Pain Scale (30 Days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sandeep J Khandhar, MD | Cardiac, Vascular, and Thoracic Surgery Associates | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiac, Vascular, and Thoracic Surgery Associates | Falls Church | Virginia | 22042 | United States | ||
| Inova Fairfax Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19022040 | Background | Whitson BA, Groth SS, Duval SJ, Swanson SJ, Maddaus MA. Surgery for early-stage non-small cell lung cancer: a systematic review of the video-assisted thoracoscopic surgery versus thoracotomy approaches to lobectomy. Ann Thorac Surg. 2008 Dec;86(6):2008-16; discussion 2016-8. doi: 10.1016/j.athoracsur.2008.07.009. | |
| 19699918 | Background |
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| ID | Title | Description |
|---|---|---|
| FG000 | Exparel | Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle. |
| FG001 | 0.25% Standard Bupivicaine | Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Randomization |
|
| ||||||||||||||||||
| 30-Day Follow-Up Phone Call |
|
Two patients who were enrolled were not randomized due to screen failing after consent. These two patients are not included in the baseline population.
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| ID | Title | Description |
|---|---|---|
| BG000 | Exparel | Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Overall Amounts of Pain Medications Consumed Through Post-operative Day 7 | Using questionnaires, patients are asked if they took Dilaudid, Tylenol, Motrin, or other opioids and if so, how many tablets. | 4 participants from the Exparel group and 6 participants from the standard group did not return a questionnaire. | Posted | Number | tablets | Assessed daily for 7 days post-procedure |
|
From procedure until the 30-day (plus or minus 10 days) post-procedure phone call.
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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 | Exparel | Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. Liposomal Bupivicaine: 266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization | Psychiatric disorders | Non-systematic Assessment | Anxiety |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Amaurosis Fugax | Nervous system disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Devon Collins | Inova Health System | 703-776-4096 | Devon.Collins@inova.org |
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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 26, 2015 | Apr 24, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010146 | Pain |
| ID | Term |
|---|---|
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 0.25% standard bupivicaine | Drug | standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. |
|
|
Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. |
| Assessed at 30 days post-procedure |
| Number of Patients With Paresthesias (Postoperatively at 7 Days) | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure. | Assessed at day 7 post-procedure |
| Proportion of Patients With Paresthesias (Postoperatively at 30 Days) | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves | Assessed at day 30 post-procedure |
| Hospital Length of Stay | Median length of stay in days until discharge. | From end of procedure until discharge, usually 0-2 days. |
| Return to Baseline Activity | Using surveys, patients are asked if they have been able to return to baseline activity levels. | Assessed at 30 days post-procedure |
| Return to Work | Using surveys, patients are asked if they have been able to return to work. | Assessed at 30 days post-procedure |
| Days Until Return to Work | Using surveys, the number of days to return to work was assessed for patients who were able to return to work. | Assessed at 30 days post-procedure |
| Overall Hospital Cost | Overall hospital cost of patient procedure and stay will be assessed. | Total cost assessed from patient registration until discharge to home (usually 0-2 days). |
| Falls Church |
| Virginia |
| 22042 |
| United States |
| Allen MS, Halgren L, Nichols FC 3rd, Cassivi SD, Harmsen WS, Wigle DA, Shen KR, Deschamps C. A randomized controlled trial of bupivacaine through intracostal catheters for pain management after thoracotomy. Ann Thorac Surg. 2009 Sep;88(3):903-10. doi: 10.1016/j.athoracsur.2009.04.139. |
| 1914056 | Background | Chan VW, Chung F, Cheng DC, Seyone C, Chung A, Kirby TJ. Analgesic and pulmonary effects of continuous intercostal nerve block following thoracotomy. Can J Anaesth. 1991 Sep;38(6):733-9. doi: 10.1007/BF03008451. |
| 12969101 | Background | Debreceni G, Molnar Z, Szelig L, Molnar TF. Continuous epidural or intercostal analgesia following thoracotomy: a prospective randomized double-blind clinical trial. Acta Anaesthesiol Scand. 2003 Oct;47(9):1091-5. doi: 10.1034/j.1399-6576.2003.00208.x. |
| 9725371 | Background | Kaiser AM, Zollinger A, De Lorenzi D, Largiader F, Weder W. Prospective, randomized comparison of extrapleural versus epidural analgesia for postthoracotomy pain. Ann Thorac Surg. 1998 Aug;66(2):367-72. doi: 10.1016/s0003-4975(98)00448-2. |
| 15166580 | Background | American Society of Anesthesiologists Task Force on Acute Pain Management. Practice guidelines for acute pain management in the perioperative setting: an updated report by the American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology. 2004 Jun;100(6):1573-81. doi: 10.1097/00000542-200406000-00033. No abstract available. |
| NOT COMPLETED |
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|
| 0.25% Standard Bupivicaine |
Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. |
| 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 | Number | participants |
|
Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. |
|
|
| Secondary | Scores on a Analog Pain Scale (7 Days) | Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. | Posted | Median | Inter-Quartile Range | Median score on postoperative day 7 | Assessed at day 7 post-procedure |
|
|
|
| Secondary | Scores on an Analog Pain Scale (30 Days) | Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain. | 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey. | Posted | Median | Inter-Quartile Range | Median score on postoperative day 30 | Assessed at 30 days post-procedure |
|
|
|
| Secondary | Number of Patients With Paresthesias (Postoperatively at 7 Days) | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure. | Posted | Count of Participants | Participants | Assessed at day 7 post-procedure |
|
|
|
| Secondary | Proportion of Patients With Paresthesias (Postoperatively at 30 Days) | Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves | 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30-day survey. | Posted | Count of Participants | Participants | Assessed at day 30 post-procedure |
|
|
|
| Secondary | Hospital Length of Stay | Median length of stay in days until discharge. | Posted | Median | Inter-Quartile Range | days | From end of procedure until discharge, usually 0-2 days. |
|
|
|
| Secondary | Return to Baseline Activity | Using surveys, patients are asked if they have been able to return to baseline activity levels. | 42 subjects in the Exparel group and 47 subjects in the standard group completed the 30 day survey. | Posted | Count of Participants | Participants | Assessed at 30 days post-procedure |
|
|
|
| Secondary | Return to Work | Using surveys, patients are asked if they have been able to return to work. | 42 subjects in the Exparel group and 47 patients in the standard group completed the 30-day survey. | Posted | Count of Participants | Participants | Assessed at 30 days post-procedure |
|
|
|
| Secondary | Days Until Return to Work | Using surveys, the number of days to return to work was assessed for patients who were able to return to work. | At the 30-day call, 24 subjects in the Exparel group and 17 subjects in the standard group indicated that they were able to return to work. Number of days were assessed for these subjects. | Posted | Median | Inter-Quartile Range | days | Assessed at 30 days post-procedure |
|
|
|
| Secondary | Overall Hospital Cost | Overall hospital cost of patient procedure and stay will be assessed. | Data on hospital cost was not collected. | Posted | Total cost assessed from patient registration until discharge to home (usually 0-2 days). |
|
|
| 0 |
| 49 |
| 1 |
| 49 |
| 5 |
| 49 |
| EG001 | 0.25% Standard Bupivicaine | Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle. 0.25% standard bupivicaine: standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle. | 0 | 49 | 0 | 49 | 0 | 49 |
| Nose bleeds | Blood and lymphatic system disorders | Non-systematic Assessment |
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| Urinary blockage | Renal and urinary disorders | Non-systematic Assessment |
|
| Brain tumor | Nervous system disorders | Non-systematic Assessment |
|
| Occipital Neuralgia | Nervous system disorders | Non-systematic Assessment |
|
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