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Trial record 1 of 1 for:    NCT02499159
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Pain Management in Response to Exparel vs. Standard Bupivicaine (VATS Exparel)

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ClinicalTrials.gov Identifier: NCT02499159
Recruitment Status : Active, not recruiting
First Posted : July 16, 2015
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
Mednax National Medical Group
Information provided by (Responsible Party):
Inova Health Care Services

Brief Summary:

This study is looking to evaluate the efficacy of liposomal bupivicaine (Exparel) on decreasing the amount of consumed pain medications.

Patients will be randomly selected to received either Exparel or standard bupivicaine injection during surgery. Patients will be followed up to assess pain levels using a visual pain scale, and to assess how much pain medication was consumed.


Condition or disease Intervention/treatment Phase
Pain Drug: Liposomal Bupivicaine Drug: 0.25% standard bupivicaine Phase 4

Detailed Description:

Exparel is a formulation of liposomal bupivacaine that is reported to allow local anesthesia for up to 72 hours post injection.

It is the investigators' aim to follow their prior study with a randomized trial to compare local infiltration of liposomal bupivacaine at the conclusion of each procedure with injections of standard .25% bupivacaine.

Patients in group A will receive, at the end of the surgical procedure, injections of liposomal bupivacaine (Exparel) (266 mg, 20 mL, diluted at surgeon's discretion) into the thoracoscopic port incision sites and around the intercostal nerves serving that space.

Patients in group B will receive, at the end of the surgical procedure, injections of standard .25% bupivacaine into the thoracoscopic port incision sites and around the intercostal nerves serving that space.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy
Study Start Date : December 2014
Estimated Primary Completion Date : June 2018
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Exparel
Liposomal Bupivicaine (Exparel) - 266 mg, 20 mL total, diluted at surgeon's discretion, Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
Drug: Liposomal Bupivicaine
266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.
Other Name: Exparel

Active Comparator: 0.25% standard bupivicaine
Bupivicaine - 0.25%, 20 mL total. Two doses of 10 mL each, into two separate incisions, delivered via 22 gauge needle.
Drug: 0.25% standard bupivicaine
standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.
Other Name: Bupivicaine




Primary Outcome Measures :
  1. Overall Amounts of Pain Medications Consumed through Post-operative Day 7 [ Time Frame: Assessed daily for 7 days post-procedure ]
    Using questionnaires, patients are asked if they took Dilaudid, Tylenol, or Motrin, and if so, how many tablets.


Secondary Outcome Measures :
  1. Analog Pain Scores [ Time Frame: Assessed daily for 7 days post-procedure, and again at 30 days post-procedure ]
    Using questionnaires, patients are asked what their pain level is based on a scale from 0-10.

  2. Incidence of Paresthesias [ Time Frame: Assessed at day 7 and again at day 30 post-procedure ]
    Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves

  3. Hospital Length of Stay [ Time Frame: From end of procedure until discharge, usually 0-2 days. ]
    Length of stay in days until discharge, usually 0-2 days.

  4. Return to Baseline Activity [ Time Frame: Assessed at 30 days post-procedure ]
    Using surveys, patients are asked if they have been able to return to baseline activity levels.

  5. Return to Work [ Time Frame: Assessed at 30 days post-procedure ]
    Using surveys, patients are asked if they have been able to return to work and, if so, how many days it took to return to work.

  6. Overall Hospital Cost [ Time Frame: Total cost assessed from patient registration until discharge to home (usually 0-2 days). ]
    Overall hospital cost of patient procedure and stay will be assessed.



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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:

  • All patients over 18 years of age
  • Isolated thoracoscopic procedure for therapeutic or diagnostic purposes

Exclusion Criteria:

  • Previous ipsilateral thoracic surgery
  • Need for operative pleurectomy or pleurodesis
  • Chronic use of pain medication -narcotics or nonsteroidal antiinflammatory drugs (NSAIDs), sedatives, or hypnotics
  • Allergies to bupivacaine or other local anesthetics, narcotics, NSAIDs or acetaminophen
  • Liver dysfunction (INR > 1.5, albumin < 2.8g/dl, bilirubin > 2mg/dl)
  • Renal dysfunction (eGFR < 60ml/min/1.73m2)
  • History of peptic ulcerative disease
  • Severe chronic obstructive pulmonary disease (COPD) requiring continuous oxygen supplementation
  • Inability to consent
  • Pregnancy
  • Need for conversion from a Video-Assisted Thoracic Surgery procedure to a thoracotomy
  • Patient is discharged from the hospital with a chest tube in place
  • Patient fails to comply with post-operative instructions

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): NCT02499159


Locations
United States, Virginia
Cardiac, Vascular, and Thoracic Surgery Associates
Falls Church, Virginia, United States, 22042
Inova Fairfax Hospital
Falls Church, Virginia, United States, 22042
Sponsors and Collaborators
Inova Health Care Services
Mednax National Medical Group
Investigators
Principal Investigator: Sandeep J Khandhar, MD Cardiac, Vascular, and Thoracic Surgery Associates

Publications of Results:

Responsible Party: Inova Health Care Services
ClinicalTrials.gov Identifier: NCT02499159     History of Changes
Other Study ID Numbers: 14-1656
First Posted: July 16, 2015    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Keywords provided by Inova Health Care Services:
Exparel
Thoracoscopy
Bupivicaine
Liposomal

Additional relevant MeSH terms:
Bupivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents