Exparel and Marcaine for Pain Management in Thoracoscopic Lobectomy Patients (BEMP)
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ClinicalTrials.gov Identifier: NCT03682224 |
Recruitment Status :
Completed
First Posted : September 24, 2018
Results First Posted : January 12, 2023
Last Update Posted : January 12, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Non Small Cell Lung Cancer Lung Cancer Stage 1 | Drug: Liposomal Bupivacaine Drug: Bupivacaine-Epinephrine | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 57 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Participants will be randomly assigned to receive either Exparel or Marcaine during surgery. Based on the randomization they will receive one of the two drugs. Participants are assigned one of the two groups in parallel for the duration of the study |
Masking: | Single (Participant) |
Masking Description: | The participant will not be aware of the drug group. A study statistician will generate the randomization with two arms. Statistician will be blinded and will not be aware of the treatment allocation. Researchers and clinicians will be aware of the allocation and drugs will be dispensed by the hospital pharmacy based on the allocation sequence. |
Primary Purpose: | Treatment |
Official Title: | A Prospective, Randomized, Single-Blind, Active Control Trial to Compare Safety and Effectiveness Of Liposomal Bupivacaine (Exparel) to Standard Bupivacaine HCl (Marcaine) for Pain Management in Patients Undergoing Video-Assisted Thoracoscopic Lobectomy |
Actual Study Start Date : | July 5, 2018 |
Actual Primary Completion Date : | September 3, 2022 |
Actual Study Completion Date : | September 3, 2022 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Exparel |
Drug: Liposomal Bupivacaine
Liposomal Bupivacaine 1.3% (Exparel), 20 ml vial for injection, administered subcutaneously at port site |
Active Comparator: Marcaine |
Drug: Bupivacaine-Epinephrine
Bupivacaine-Epinephrine 0.25%, 1:200,000 (Marcaine with epinephrine), administered subcutaneously at port site |
- Total Morphine Equivalents Consumed [ Time Frame: up to 72 hours post surgery ]Measured as overall intake of any drugs in the opioid class (Morphine Equivalent Dosing)
- VAS Pain Score [ Time Frame: In-hospital until discharge, approximately 3 days, will be collected each time before dispensing pain medications ]Using a 10 point visual analog scale (VAS) score. The score ranges from 0 to 10. '0' represents no pain and '10' represents worst pain.
- Treatment Cost [ Time Frame: In-hospital Costs until discharge, approximately 3 days ]All direct cost from the date of surgery until discharge
- Pharmacy Cost [ Time Frame: In-hospital until discharge, approximately 3 days ]Median In-hospital pharmacy cost
- Mortality [ Time Frame: Up to 30 days post surgery ]Any death occurring during primary hospital stay or prior to 30 days post surgery
- Hospital Stay [ Time Frame: Length of hospital stay - from admission to discharge, approximately 3 days ]
- Pneumothorax [ Time Frame: In-hospital until discharge, approximately 3 days ]Documented pnuemothorax
- Prolonged Air Leak [ Time Frame: > 5 days to 7 days ]Number of patients who had air leak more than 5 days post-surgery
- Atrial Fibrillation/Other Arrhythmia [ Time Frame: In-hospital until discharge, approximately 3 days ]Post-op arrhythmia
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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Adult at least 18 years of age
- Subject needs elective lobectomy for non small cell lung cancer
- Willing to comply with all aspects of protocol, including providing information about opioid usage for post-surgical pain and signed informed consent
Exclusion Criteria:
- < 18 years of age, > 80 years of age
- Inability or unwillingness to consent
- Emergency surgery
- Previous ipsilateral thoracic surgery
- Need for operative pleurectomy or pleurodesis
- Chronic Narcotic use
- Any narcotic use in the 1 month period prior to screening
- Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
- Moderate to severe hepatic impairment (ALT or AST) value greater than 3 times the upper limit of normal.
- Severe renal impairment or end stage renal failure disease (creatinine greater than 2.0 mg/dl).
- History of peptic ulcerative disease
- Severe chronic obstructive pulmonary disease (COPD) due to LVRS (lung-volume reduction surgery).
- Pregnancy
- Need for conversion from a Video-Assisted Thoracic Surgery procedure to an open thoracotomy
- Subjects who are incarcerated
- Subject has been treated with an experimental device within 30 days or received an experimental agent within the longer of 30 days or five half-lives. Or subject is current enrolled in another clinical trial.
- Unable to follow protocol directions due to organic brain or psychiatric disease.
- History of alcoholism or any other substance abuse, which, in the opinion of the investigator, would affect compliance with the protocol.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03682224
United States, Illinois | |
Memorial Medical Center, Southern Illinois University-School of Medicine | |
Springfield, Illinois, United States, 62781 |
Principal Investigator: | Traves Crabtree, MD | Professor of Surgery | |
Study Director: | Stephen Hazelrigg, MD | Professor of Surgery |
Documents provided by Southern Illinois University:
Responsible Party: | Southern Illinois University |
ClinicalTrials.gov Identifier: | NCT03682224 |
Other Study ID Numbers: |
CRABTREE-18-185 |
First Posted: | September 24, 2018 Key Record Dates |
Results First Posted: | January 12, 2023 |
Last Update Posted: | January 12, 2023 |
Last Verified: | December 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | No |
clinical trial bupivacaine-epinephrine bupivacaine liposome pain Morphine equivalent dose |
lobectomy Laproscopic lobectomy VATS lobectomy opioid medications |
Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases Epinephrine Bupivacaine Anesthetics, Local Anesthetics Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents |
Peripheral Nervous System Agents Adrenergic alpha-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Bronchodilator Agents Autonomic Agents Anti-Asthmatic Agents Respiratory System Agents Mydriatics Sympathomimetics Vasoconstrictor Agents |