Local Anesthetic as Single Shot Versus Catheter in Patients Undergoing Video Assisted Thoracoscopic Surgery

May 27, 2025 updated by: Poovendran Saththasivam

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivicaine) Versus Continuous Erector Spinae Plane Block Catheter in Patients Undergoing Video Assisted Thoracoscopic (VAT) Surgery; Single Center, Non Inferiority, Open Label, Randomized Trial

The purpose of this research is to compare a single shot long acting local anesthetic to catheter infusion of local anesthetic in patients undergoing video assisted thoracoscopic (VAT) surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The purpose of this research is to compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% bolus followed by 0.2% infusion of local anesthetic using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
45

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Sayre, Pennsylvania, United States, 18840
        • Robert Packer Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subjects who are age > 18, undergoing video thoracoscopic surgery and following Guthrie Robert Packer Hospital's Enhanced Recovery After Surgery (ERAS) protocol for Thoracic Surgery.

Exclusion Criteria:

  • weight < 50 kg, pregnant subjects,
  • left ventricular ejection fraction < 30%,
  • history of drug or narcotic abuse,
  • history of allergic to amide local anesthetic,
  • presence of contraindication for erector spinae plane block (local skin infection, sepsis, severe coagulopathy)
  • unable to provide consent,
  • unable to use pain rating scales as demonstrated by verbal feedback
  • preoperative chronic pain on narcotics,
  • history of renal insufficiency ( Creatinine > 1.5 mg/dl),
  • preoperative mild liver impairment ( i.e. AST/ALT above 1.5 times the upper normal limit)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic
Drug: Liposomal Bupivacaine (EXPAREL®)/Bupivacaine
Single shot for erector spinae block
Other Names:
  • EXPAREL®/Bupivacaine
Active Comparator: Continuous catheter infusion ropivacaine
Ropivacaine (0.5% bolus followed by 0.2% infusion) using a continuous catheter for erector spinae plane block as local anesthetic
Drug: Ropivacaine (0.5% bolus followed by 0.2% infusion)
Continuous catheter infusion for erector spinae plane block
Other Names:
  • Ropivacaine

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Numeric Rated Pain Scale at Rest 0-4 Hours Post-operative
Time Frame: 0-4 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
0-4 hours post operative
Numeric Rated Pain Scale at Rest 4-8 Hours Post-operative
Time Frame: 4-8 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
4-8 hours post operative
Numeric Rated Pain Scale at Rest 8-12 Hours Post-operative
Time Frame: 8-12 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
8-12 hours post operative
Numeric Rated Pain Scale at Rest 12-24 Hours Post-operative
Time Frame: 12-24 hours post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
12-24 hours post operative
Numeric Rated Pain Scale at Rest 24-48 Hours Post-operative
Time Frame: 2 days post operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
2 days post operative
Numeric Rated Pain Scale 48-72 Hours Post-operative
Time Frame: 3 days post-operative
Patient reported pain scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
3 days post-operative
Numeric Rated Pain Scale With Cough 0-4 Hours Post-operative
Time Frame: 0-4 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
0-4 hours post-operative
Numeric Rated Pain Scale With Cough 4-8 Hours Post-operative
Time Frame: 4-8 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
4-8 hours post-operative
Numeric Rated Pain Scale With Cough 8-12 Hours Post-operative
Time Frame: 8-12 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
8-12 hours post-operative
Numeric Rated Pain Scale With Cough 12-24 Hours Post-operative
Time Frame: 12-24 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
12-24 hours post-operative
Numeric Rated Pain Scale With Cough 24-48 Hours Post-operative
Time Frame: 24-48 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
24-48 hours post-operative
Numeric Rated Pain Scale With Cough 48-72 Hours Post-operative
Time Frame: 48-72 hours post-operative
Patient reported pain with cough on a scale (0-10) with zero (0) meaning "no pain" and ten (10) meaning "the worst pain imaginable
48-72 hours post-operative

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Opioid Consumption in Morphine Equivalent Dose 0-4 Hours Post-operative
Time Frame: 0-4 hours post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
0-4 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 4-8 Hours Post-operative
Time Frame: 4-8 hours post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
4-8 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 8-16 Hours Post-operative
Time Frame: 8-16 hours post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
8-16 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 16-24 Hours Post-operative
Time Frame: 16-24 hours post-operative
Post-operative opioid consumption in morphine equivalent dose (MED to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
16-24 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 24-48 Hours Post-operative
Time Frame: 24-48 hours post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
24-48 hours post-operative
Opioid Consumption in Morphine Equivalent Dose 48-72 Hours Post-operative
Time Frame: 48-72 hours post-operative
Post-operative opioid consumption in morphine equivalent dose (MED) to determine total opioid medications given in the time period. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
48-72 hours post-operative
Total Intraoperative Opioid Consumption in Morphine Equivalent Dose
Time Frame: From start of surgery to end of surgery, an average of 2-3 hours
Total opioids administered in morphine equivalent dose (MED) in the operating room during the surgery. MED is a standard conversion factor developed by the United States Centers for Disease Control and Prevention (CDC). The MED equates the many different opioids into a standard value that is based on morphine and its potency.
From start of surgery to end of surgery, an average of 2-3 hours
Acetaminophen Consumption in Milligrams 0-4 Hours Post-operative
Time Frame: 0-4 hours post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
0-4 hours post-operative
Acetaminophen Consumption in Milligrams 4-8 Hours Post-operative
Time Frame: 4-8 hours post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
4-8 hours post-operative
Acetaminophen Consumption in Milligrams 8-16 Hours Post-operative
Time Frame: 8-16 hours post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
8-16 hours post-operative
Acetaminophen Consumption in Milligrams 16-24 Hours Post-operative
Time Frame: 16-24 hours post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
16-24 hours post-operative
Acetaminophen Consumption in Milligrams 24-48 Hours Post-operative
Time Frame: 24-48 hours post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
24-48 hours post-operative
Acetaminophen Consumption in Milligrams 48-72 Hours Post-operative
Time Frame: 48-72 hours post-operative
Acetaminophen is a pain medication that is not an opioid. The acetaminophen use in milligrams will be compared in each group at different time points.
48-72 hours post-operative
Gabapentin Consumption in Milligrams 0-4 Hours Post-operative
Time Frame: 0-4 hours post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
0-4 hours post-operative
Gabapentin Consumption in Milligrams 4-8 Hours Post-operative
Time Frame: 4-8 hours post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
4-8 hours post-operative
Gabapentin Consumption in Milligrams 8-16 Hours Post-operative
Time Frame: 8-16 hours post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
8-16 hours post-operative
Gabapentin Consumption in Milligrams 16-24 Hours Post-operative
Time Frame: 16-24 hours post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
16-24 hours post-operative
Gabapentin Consumption in Milligrams 24-48 Hours Post-operative
Time Frame: 24-48 hours post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
24-48 hours post-operative
Gabapentin Consumption in Milligrams 48-72 Hours Post-operative
Time Frame: 48-72 hours post-operative
Gabapentin is a pain medication that is not an opioid. The gabapentin use in milligrams will be compared in each group at different time points.
48-72 hours post-operative
Ketorolac Consumption in Milligrams 0-4 Hours Post-operative
Time Frame: 0-4 hours post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
0-4 hours post-operative
Ketorolac Consumption in Milligrams 4-8 Hours Post-operative
Time Frame: 4-8 hours post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
4-8 hours post-operative
Ketorolac Consumption in Milligrams 8-16 Hours Post-operative
Time Frame: 8-16 hours post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
8-16 hours post-operative
Ketorolac Consumption in Milligrams 16-24 Hours Post-operative
Time Frame: 16-24 hours post-operative
The ketorolac use in milligrams will be compared in each group at different time points.
16-24 hours post-operative
Ketorolac Consumption in Milligrams 24-48 Hours Post-operative
Time Frame: 24-48 hours post-operative.
The ketorolac use in milligrams will be compared in each group at different time points.
24-48 hours post-operative.
Ketorolac Consumption in Milligrams 48-72 Hours Post-operative
Time Frame: 48-72 hours post-operative
Ketorolac is a pain medication that is not an opioid. The ketorolac use in milligrams will be compared in each group at different time points.
48-72 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 12-24 Hours Post-operative
Time Frame: 12-24 hours post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
12-24 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 24 to 48 Hours Post-operative
Time Frame: 24-48 hours post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
24-48 hours post-operative
Postoperative Quality of Recovery Score (QOR-15) 48 to 72 Hours Post-operative
Time Frame: 48-72 hours post-operative
A survey on patient reported outcomes which consists of 15 questions related to five domains of patient reported health status (pain, physical comfort, physical independence, psychological support and emotional state). The score is reported on a scale from 0 to 150 with higher scores meaning a better outcome.
48-72 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 0-4 Hours Post-operative
Time Frame: 0-4 hours post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 0 to 4 hours post-operative). A negative number reflects reduced volume of air.
0-4 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 4-8 Hours Post-operative
Time Frame: 4-8 hours post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 4 to 8 hours post-operative). A negative number reflects reduced volume of air.
4-8 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 8-12 Hours Post-operative
Time Frame: 8-12 hours post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 8 to 12 hours post-operative). A negative number reflects reduced volume of air.
8-12 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 12-24 Hours Post-operative
Time Frame: 12-24 hours post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 12 to 24 hours post-operative). A negative number reflects reduced volume of air.
12-24 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 24-48 Hours Post-operative
Time Frame: 24-48 hours post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 24 to 48 hours post-operative). A negative number reflects reduced volume of air.
24-48 hours post-operative
Post-operative Incentive Spirometry Changes From Preoperative Baseline at 48-72 Hours Post-operative
Time Frame: 48-72 hours post-operative
Incentive spirometry measures how much air you can inhale, which can help indicate how well your lungs are working after surgery. Incentive spirometry measures the volume (or amount) of air you inhale measured in cubic centimeters (cc). Higher numbers indicate that you're inhaling more air. This measure will be the change in incentive spirometry from baseline (baseline incentive spirometry - incentive spirometry 48 to 72 hours post-operative). A negative number reflects reduced volume of air.
48-72 hours post-operative
Length of Hospital Stay
Time Frame: From date of admission until date of discharge, an average of 72 hours
Number of hours from admission to discharge
From date of admission until date of discharge, an average of 72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Poovendran Saththasivam

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Poovendran Saththasivam, MD, The Guthrie Clinic

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 10, 2020

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 7, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 16, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 22, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2007-48

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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