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Liposomal Bupivacaine for Pain Control Following Thoracic Surgery.

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ClinicalTrials.gov Identifier: NCT03036085
Recruitment Status : Unknown
Verified January 2017 by Harald Ott, Massachusetts General Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 30, 2017
Last Update Posted : January 30, 2017
Sponsor:
Information provided by (Responsible Party):
Harald Ott, Massachusetts General Hospital

Brief Summary:
The aims of the study are to compare the effectiveness and postoperative outcomes of liposomal bupivacaine vs plain bupivacaine following video-assisted thoracoscopic surgery. The investigators' hypothesis is that liposomal bupivacaine will decrease the postoperative pain and will be associated with more favorable postoperative outcomes when compared to plain bupivacaine following video-assisted thoracoscopic surgery.

Condition or disease Intervention/treatment Phase
Pain, Postoperative Thoracic Diseases Local Anesthetics Causing Adverse Effects in Therapeutic Use Opioid Dependence Drug: Liposomal bupivacaine Drug: Bupivacaine Drug: Epinephrine Drug: Normal saline Phase 2 Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Liposomal Bupivacaine Versus Bupivacaine for Postoperative Analgesia Following Video-assisted Thoracoscopic Surgery.
Estimated Study Start Date : February 2017
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bupivacaine
Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with 0.5% bupivacaine with 1% epinephrine. In the bupivacaine group 20 ml of 0.5% bupivacaine with 1% epinephrine will be diluted to a total volume of 40 ml using 20 ml normal saline. From those 40 ml, 30 ml will be used for the posterior intercostal nerve block and 10 ml will be injected locally into the surgical wounds.
Drug: Bupivacaine
In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with bupivacaine plus epinephrine plus normal saline.
Other Names:
  • Marcaine
  • Marcain
  • Sensorcaine
  • Vivacaine

Drug: Epinephrine
In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with bupivacaine plus epinephrine plus normal saline.
Other Names:
  • Adrenaline
  • Adrenalin

Drug: Normal saline
In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with liposomal bupivacaine plus normal saline or with bupivacaine plus epinephrine plus normal saline.

Experimental: Liposomal bupivacaine
Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with liposomal bupivacaine (13.3 mg/ml). In the liposomal bupivacaine group, a total dose of 266 mg of liposomal bupivacaine (one 20 ml vial of 13.3 mg/ml) per patient will be diluted to a total volume of 40 ml using 20 ml normal saline.
Drug: Liposomal bupivacaine
In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with liposomal bupivacaine plus normal saline.
Other Name: Exparel

Drug: Normal saline
In the operating room after induction of general anesthesia patients will be positioned in a lateral decubitus position, prepared and draped in a sterile fashion. Under thoracoscopic guidance, a posterior intercostal nerve block will be performed with liposomal bupivacaine plus normal saline or with bupivacaine plus epinephrine plus normal saline.




Primary Outcome Measures :
  1. Patient self-reported pain visual analog scale score - Day 1 [ Time Frame: Postoperative Day #1 ]

Secondary Outcome Measures :
  1. Patient self-reported pain visual analog scale score - Day 3 [ Time Frame: Postoperative Day #3 ]
  2. Patient self-reported pain visual analog scale score - Discharge [ Time Frame: At the day of discharge from the hospital. Discharge day could be on average postoperative day #4 or #5. ]
  3. Time until first opioid usage [ Time Frame: After the surgery and until the participant receives the first opioid medication, assessed up to 10 days after surgery. ]
  4. Total opioid usage (in morphine equivalents) [ Time Frame: After the surgery and until the participant is discharged from the hospital. Discharge day could be on average postoperative day #4 or #5. ]
  5. Anti-emetic usage [ Time Frame: After the surgery and until the participant is discharged from the hospital. Discharge day could be on average postoperative day #4 or #5. ]
  6. Naloxone usage [ Time Frame: After the surgery and until the participant is discharged from the hospital. Discharge day could be on average postoperative day #4 or #5. ]
  7. Length of hospital stay [ Time Frame: After the surgery and until the participant is discharged from the hospital. Discharge day could be on average postoperative day #4 or #5. ]
  8. Postoperative complications (e.g. pneumonia, pulmonary complications, wound infections etc) [ Time Frame: The first 30 days after surgery ]
  9. Time to ambulation [ Time Frame: After the surgery and until the participant starts ambulating during hospitalization, assessed up to 10 days after surgery. ]
  10. Time to first bowel movement [ Time Frame: After the surgery and until the participant has the first bowel movement during hospitalization, assessed up to 10 days after surgery. ]
  11. Time to chest tube removal [ Time Frame: After the surgery and until the participant has his/her chest tube removed during hospitalization, assessed up to 10 days after surgery. ]
  12. Peak expiratory flow measurements [ Time Frame: Measured twice daily following surgery until the participant is discharged from the hospital. Discharge day could be on average postoperative day #4 or #5. ]
    Measures air flowing in and out of the lungs.

  13. Peak expiratory flow measurements [ Time Frame: Measured twice daily the day at the first postoperative visit (usually within 10-30 days postoperatively) ]
    Measures air flowing in and out of the lungs.



Information from the National Library of Medicine

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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:

  • Eligible patients would be all patients aged older than 18 years who undergo a video-assisted thoracoscopic lung resection at Massachusetts General Hospital.

Exclusion Criteria:

  • Pregnant women, prisoners, emergent cases, patients under 18 years, and patients with chronic pain, documented alcohol or drug abuse and allergies to bupivacaine will be excluded from this study.

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): NCT03036085


Contacts
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Contact: Konstantinos P. Economopoulos, MD, PhD 617-510-4641 keconomopoulos@mgh.harvard.edu
Contact: Harald Ott, MD 617-726-2311 hott@mgh.harvard.edu

Sponsors and Collaborators
Massachusetts General Hospital
Investigators
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Principal Investigator: Harald Ott, MD Division of Thoracic Surgery, Massachusetts General Hospital

Additional Information:
Publications of Results:

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Responsible Party: Harald Ott, Associate Professor of Surgery, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT03036085     History of Changes
Other Study ID Numbers: 2016P002754
First Posted: January 30, 2017    Key Record Dates
Last Update Posted: January 30, 2017
Last Verified: January 2017
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
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Harald Ott, Massachusetts General Hospital:
postoperative pain
video-assisted thoracoscopic surgery (VATS)
opioids
bupivacaine
liposomal bupivacaine
analgesia
local anesthetics

Additional relevant MeSH terms:
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Thoracic Diseases
Pain, Postoperative
Opioid-Related Disorders
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders
Respiratory Tract Diseases
Epinephrine
Racepinephrine
Bupivacaine
Epinephryl borate
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