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Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

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ClinicalTrials.gov Identifier: NCT03560362
Recruitment Status : Unknown
Verified June 2018 by Benny Weksler, University of Tennessee Health Science Center.
Recruitment status was:  Recruiting
First Posted : June 18, 2018
Last Update Posted : June 20, 2018
Sponsor:
Information provided by (Responsible Party):
Benny Weksler, University of Tennessee Health Science Center

Study Description
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Brief Summary:
Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Lung Cancer Drug: Bupivacaine liposome Drug: Bupivacaine / Epinephrine Phase 1 Phase 2

Detailed Description:
Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery
Actual Study Start Date : July 9, 2015
Estimated Primary Completion Date : October 31, 2018
Estimated Study Completion Date : October 31, 2018

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Bupivacaine with epinephrine
Patients will receive intraoperative intercostal nerve block with bupivacaine
 Drug: Bupivacaine / Epinephrine
Experimental: Lipossomal extended release bupivacaine
Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine
 Drug: Bupivacaine liposome


Outcome Measures
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Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 3-5 days post op ]
    Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.


Secondary Outcome Measures :
  1. Postoperative complications [ Time Frame: 90 days post op ]
    Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.

  2. Narcotic used [ Time Frame: 3-5 days post op ]
    Amount of morphine equivalent dosage used in the postoperative period


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients who will be undergoing minimally invasive thoracic surgery

  • Patients who will be undergoing minimally invasive thoracic surgery

Exclusion Criteria:

  • Open surgery
  • Chronic use of narcotics
  • Use of pregabalin or similar
  • Significant liver or kidney dysfunction
Contacts and Locations
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Information from the National Library of Medicine

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): NCT03560362


Contacts
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Contact: Benny Weksler, MD 901-448-2918 bweksler@uthsc.edu
Contact: Suzie Glass, RN 901-448-2918 Suzie.Glass@mlh.org

Locations
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United States, Tennessee
Methodist University Hospital Recruiting
Memphis, Tennessee, United States, 38104
Contact: Benny Weksler    901-448-2918    bweksler@uthsc.edu   
Sponsors and Collaborators
University of Tennessee Health Science Center
Investigators
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Principal Investigator: Benny Weksler, MD University of Tennessee Health Science Center
More Information
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Responsible Party: Benny Weksler, Professor of Surgery, University of Tennessee Health Science Center
ClinicalTrials.gov Identifier: NCT03560362    
Other Study ID Numbers: 15-03838
First Posted: June 18, 2018    Key Record Dates
Last Update Posted: June 20, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Benny Weksler, University of Tennessee Health Science Center:
bupivacaine
lipossomal extended release bupivacaine
Intercostal nerve block
thoracic surgery
minimally invasive surgery
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
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