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The purpose of the study is to examine the safety and efficacy of liposome bupivacaine for intercostal nerve block in subjects undergoing posterolateral thoracotomy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EXPAREL 266 mg | Active Comparator | Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments) |
|
| Placebo | Placebo Comparator | Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EXPAREL 266 mg | Drug |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Curve (AUC) of Pain Intensity at Rest Through 72 Hours | AUC of pain intensity scores at rest through 72 hours postsurgery. Participants assumed a resting position that did not exacerbate his or her postsurgical pain. Pain intensity scores were measured at baseline and 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours postsurgery, at first request for rescue pain medication, and on day 12 using the numeric rating scale at rest (NRS-R; 0=no pain and 10=worst possible pain). | 0-72 hours postsurgery |
| Measure | Description | Time Frame |
|---|---|---|
| Total Postsurgical Opioid Consumption Through 72 Hours | Total postsurgical opioid consumption (morphine equivalent) through 72 hours postsurgery | 0-72 hours postsurgery |
| Time to First Opioid Rescue Through 72 Hours Postsurgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Erol Onel, MD | Pacira Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jackson Memorial Hospital/University of Miami, 1611 NW 12th Avenue (R-C300) | Miami | Florida | 33136 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | EXPAREL 266 mg | Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments) EXPAREL 266 mg |
| FG001 | Placebo |
| 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 | Yes | No | No | Study Protocol | Sep 23, 2012 | Nov 15, 2020 |
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Time to first use of opioid rescue medication through 72 hours postsurgery, calculated as the date and time of first opioid use minus the date and time of the end of surgery.
| 72 hours postsurgery |
| Louisiana State University Health Sciences Center - Shreveport, 1501 Kings Hwy |
| Shreveport |
| Louisiana |
| 71103 |
| United States |
| Sanford Heart Center 801 Broadway North | Fargo | North Dakota | 58122 | United States |
| Research Concepts, GP, LLC, 4525 Texas St. | Bellaire | Texas | 77401 | United States |
| UT Southwestern Medical Center, Dept. Cardiovas7726cular & Thoracic Surgery, 5909 Harry Hines Blvd., 9th Fl. | Dallas | Texas | 75390-8879 | United States |
| The Methodist Hospital UANEU25, Department of Cardiovascular Surgery, 6550 Fannin, Suite 1401 | Houston | Texas | 77030 | United States |
| MultiCare Health System dba Tacoma General Hospital 315 Martin Luther King Jr Way | Tacoma | Washington | 98405 | United States |
| Thoracic Surgery Clinic, SHATPulmD 'Sveta Sofia' | Plovdiv | Bulgaria |
| Department of surgery with activity in thoracic surgery | Sofia | Bulgaria |
| Military Medical Academy | Sofia | Bulgaria |
| University Multiprofile Hospiatl for Active Treatment and Emergency Medicine 'Pirogov' | Sofia | Bulgaria |
| Krajska nemocnice Liberec, a.s., Vseobecna chirurgie | Liberec | Czechia |
| Fakultni nemocnice Olomouc I. chirurgicka klinika | Olomouc | Czechia |
| Thomayerova nemocnice Oddeleni hrudni chirurgie Videnska | Prague | Czechia |
| Amtel Hospital First Clinical' LLC | Tbilisi | Georgia |
| Jsc 'National Center for Tuberculosis and Lung Diseases'/ | Tbilisi | Georgia |
| Jsc 'National Center for Tuberculosis and Lung Diseases' | Tbilisi | Georgia |
| Klinika Chirurgii Klatki Piersiowej, Chirurgii Ogolnej i Onkologicznej Uniwersytecki Szpital Kliniczny | Lodz | Poland |
| Klinika Chirurgii Klatki Piersiowej Pomorskiego Uniwersytetu Medycznego w Szczecinie Specjalistyczny Szpital im. prof. Alfreda Sokolowskiego | Szczecin | Poland |
| Oddzial Zabiegowy Kliniki Nowotworow Pluca i Klatki Piersiowej Centrum Onkologii-Instytut im. Marii Sklodowskiej-Curie | Warsaw | Poland |
| Samodzielny Publiczny Szpital Kliniczny Nr 1 im. Prof. Stanislawa Szyszko Slaskiego UM w Katowicach Klinika Anestezjologii i Intensywnej Terapii | Zabrze | Poland |
Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments) Placebo |
| COMPLETED |
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| NOT COMPLETED |
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Baseline characteristics were analyzed in the safety population, which included all participants who received study drug, with analysis based on actual treatment received. Six randomized participants (2 in the EXPAREL 266 mg group and 4 in the placebo group) did not receive study drug and were excluded from the safety population.
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| ID | Title | Description |
|---|---|---|
| BG000 | EXPAREL 266 mg | Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments) EXPAREL 266 mg |
| BG001 | Placebo | Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments) Placebo |
| BG002 | 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 | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| American Society of Anesthesiologists (ASA) classification | American Society of Anesthesiologists (ASA) classification was determined by physicians using the ASA Physical Status Classification System which assesses the patient's pre-anesthesia medical co-morbidities. ASA 1 patients would be considered a normal, healthy patient. ASA 2 is a patient with mild systemic disease (eg, smoker, well controlled diabetes or high blood pressure (HBP)). ASA 3 is a patient with severe systemic disease (eg poorly controlled diabetes or HBP). ASA 4 is a patient with severe systemic disease that is a constant threat to life (eg, recent myocardial infarction, stroke). | Count of Participants | 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 | Area Under the Curve (AUC) of Pain Intensity at Rest Through 72 Hours | AUC of pain intensity scores at rest through 72 hours postsurgery. Participants assumed a resting position that did not exacerbate his or her postsurgical pain. Pain intensity scores were measured at baseline and 1, 2, 4, 8, 12, 24, 36, 48, 60, and 72 hours postsurgery, at first request for rescue pain medication, and on day 12 using the numeric rating scale at rest (NRS-R; 0=no pain and 10=worst possible pain). | The efficacy population included all participants who received study drug, with analysis based on randomized treatment | Posted | Least Squares Mean | Standard Error | score on a scale * hr | 0-72 hours postsurgery |
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| Secondary | Total Postsurgical Opioid Consumption Through 72 Hours | Total postsurgical opioid consumption (morphine equivalent) through 72 hours postsurgery | The efficacy population included all participants who received study drug, with analysis based on randomized treatment | Posted | Mean | Standard Deviation | mg morphine equivalent dose | 0-72 hours postsurgery |
|
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| Secondary | Time to First Opioid Rescue Through 72 Hours Postsurgery | Time to first use of opioid rescue medication through 72 hours postsurgery, calculated as the date and time of first opioid use minus the date and time of the end of surgery. | Time to first use of opioid rescue medication through 72 hours postsurgery, calculated as the date and time of first opioid use minus the date and time of the end of surgery. | Posted | Median | Full Range | hours | 72 hours postsurgery |
|
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From time of randomization through the day 30 follow-up contact
The safety population included all participants who received study drug, with analysis based on actual treatment received. Treatment-emergent adverse events that were solicited from the neurological assessment or from the opioid-related AE questionnaire were included in this table.
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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 266 mg | Intercostal nerve block using single total administration of 20 mL EXPAREL (bupivacaine liposome injectable suspension) 266 mg (approximately 88 mg [6.6 mL] to each of three nerve segments) EXPAREL 266 mg | 2 | 94 | 12 | 94 | 63 | 94 |
| EG001 | Placebo | Intercostal nerve block using single total administration of 20 mL normal saline (6.6 mL to each of three nerve segments) Placebo | 4 | 91 | 10 | 91 | 55 | 91 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac Arrest | Cardiac disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Atrial fibrillation | Cardiac disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Cardiac failure acute | Cardiac disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Bronchial obstruction | Respiratory, thoracic and mediastinal disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Sepsis | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Lobar pneumonia | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Lung infection Pseudomonal | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Staphylococcal infection | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MeDRA 14.1 | Systematic Assessment |
| |
| Postprocedural hemorrhage | Injury, poisoning and procedural complications | MeDRA 14.1 | Systematic Assessment |
| |
| Heart injury | Injury, poisoning and procedural complications | MeDRA 14.1 | Systematic Assessment |
| |
| Wound dehiscence | Injury, poisoning and procedural complications | MeDRA 14.1 | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Acute renal failure | Renal and urinary disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MeDRA 14.1 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MeDRA 14.1 | Systematic Assessment |
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| White blood cell count increased | Investigations | MeDRA 14.1 | Systematic Assessment |
| |
| Cerebral hematoma | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Coma uremic | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Cholestasis | Hepatobiliary disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Brain neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MeDRA 14.1 | Systematic Assessment |
| |
| Circulatory collapse | Vascular disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Delirium | Psychiatric disorders | MeDRA 14.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Pyrexia | General disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Hypotension | Vascular disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MeDRA 14.1 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MeDRA 14.1 | Systematic Assessment |
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| Fatigue | General disorders | MeDRA 14.1 | Systematic Assessment |
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| Confusional state | Psychiatric disorders | MeDRA 14.1 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MeDRA 14.1 | Systematic Assessment |
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| Pruritus generalized | Skin and subcutaneous tissue disorders | MeDRA 14.1 | Systematic Assessment |
|
Study drug delivery to the intercostal nerve via instillation, not US-guided injection, likely prevented optimal placement/retention, as supported by pharmacokinetic data. Thus, efficacy of study drug as regional nerve block could not be meaningfully evaluated.
Any proposed publication/presentation of study-related information is subject to advance review by the Sponsor ≥60 days before intended submission/presentation. Investigator/institution shall amend publication/presentation as needed to address errors or confidential information identified by the Sponsor. If requested in writing by the Sponsor, investigator/institution shall withhold publication for an additional 90 days.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pacira Medical Information | Pacira Pharmaceuticals, Inc. | Pacira Pharmaceuticals, Inc. | MedInfo@pacira.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 26, 2013 | Nov 15, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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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 |
|
| Unknown or Not Reported |
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| Poland |
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| Bulgaria |
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| Czechia |
|
| Georgia |
|
| 2 |
|
| 3 |
|
|
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