Bupivacaine/Epinephrine +Dexamethasone vs. Liposomal Bupivacaine
Study Details
Study Description
Brief Summary
This study will assess analgesia after robotic lung surgery. Subjects will be randomized to receive wound infiltration and intercostal nerve block with either liposomal bupivacaine or bupivacaine/epinephrine + dexamethasone. Liposomal bupivacaine is a newer local anesthetic product and has not been compared to a combination of bupivacaine/epinephrine + dexamethasone in the context of pain control after robotic lung surgery.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Experimental: Bupivacaine/epinephrine + dexamethasone
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Drug: Intercostal nerve block and wound infiltration with bupivacaine/epinephrine + dexamethasone
Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 42 ml of 0.5% Bupivacaine/epinephrine with 8mg dexamethasone will be used.
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Active Comparator: Liposomal bupivacaine
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Drug: Intercostal nerve block and wound infiltration with liposomal bupivacaine
Intercostal nerve block and wound infiltration with liposomal bupivacaine during robotic lung resection surgery. 266mg of liposomal bupivacaine with 24 ml of 0.5% bupivacaine will be used.
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Outcome Measures
Primary Outcome Measures
- Visual Analogue Scale pain scores [24 hours post-surgery]
Visual Analogue Scale (VAS) pain score will be assessed for non-inferiority of bupivacaine/epinephrine +dexamethasone vs. liposomal bupivacaine. A non-inferiority margin of 2 points on the VAS scale will be considered non-inferior.
Eligibility Criteria
Criteria
Inclusion Criteria:
- undergoing robotic wedge resection or lobectomy for lung mass(es)
Exclusion Criteria:
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emergency case
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history of opiate abuse
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chronic pain syndrome
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intravenous drug use
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chronic use of oral steroids
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pregnancy
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imprisonment
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body weight lower than 70 kg
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liver failure
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uninsured patients
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non-verbal patients or patients who are unable to rate their pain on a visual analogue pain scale
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history of allergic reaction to any of the drugs used in the study: bupivacaine, liposomal bupivacaine, dexamethasone
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Cooper University Hospital | Camden | New Jersey | United States | 08103 |
Sponsors and Collaborators
- The Cooper Health System
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 18039