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OpenTrials
Completed

NCT Number: NCT02499159

Pain Management in Response to Exparel vs. Standard Bupivicaine

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.

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Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Cardiac, Vascular, and Thoracic Surgery Associates, Falls Church, Virginia, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Liposomal Bupivicaine

Drug

266 mg, 20 mL total, diluted at surgeon's discretion, delivered by 22 gauge needle.

Other names: Exparel

0.25% standard bupivicaine

Drug

standard 0.25% bupivacaine, 20 mL total, delivered by 22 gauge needle.

Other names: Bupivicaine

Primary outcomes

  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, Motrin, or other opioids and if so, how many tablets.

Secondary outcomes

  1. Scores on a Analog Pain Scale (7 Days)

    Time frame: Assessed at day 7 post-procedure

    Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.

  2. Scores on an Analog Pain Scale (30 Days)

    Time frame: Assessed at 30 days post-procedure

    Using questionnaires, patients are asked what their pain level is based on a scale from 0-10, 10 being the absolute worst pain and 0 being no pain.

  3. Number of Patients With Paresthesias (Postoperatively at 7 Days)

    Time frame: Assessed at day 7 post-procedure

    Patients are asked if they have experienced a pricking or tingling sensation caused by potential pressure or damage to peripheral nerves since the procedure.

  4. Proportion of Patients With Paresthesias (Postoperatively at 30 Days)

    Time frame: Assessed 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

  5. Hospital Length of Stay

    Time frame: From end of procedure until discharge, usually 0-2 days.

    Median length of stay in days until discharge.

  6. 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.

  7. 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.

  8. Days Until Return to Work

    Time frame: Assessed at 30 days post-procedure

    Using surveys, the number of days to return to work was assessed for patients who were able to return to work.

  9. 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.

Sponsors and collaborators

Lead sponsor

Inova Health Care Services

Other

Collaborators

  • Mednax National Medical Group

Registry information

Official study title

A Randomized Controlled Trial of the Effectiveness of Liposomal Bupivacaine (Exparel) When Compared to Local Injection of Bupivacaine After Thoracoscopy

Acronym: VATS Exparel

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jul 16, 2015
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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