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

NCT ID: NCT04559347

Last Updated: 2025-06-12

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

45 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-12-10

Study Completion Date

2024-08-07

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Thoracic Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Compare Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine (a long acting local anesthetic) to Ropivacaine (0.5% followed by 0.2% infusion using a catheter) in patients undergoing video assisted thoracoscopic (VAT) surgery.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Single Shot Liposomal Bupivacaine (EXPAREL®)/Bupivacaine for erector spinae block as local anesthetic

Group Type EXPERIMENTAL

Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Intervention Type DRUG

Single shot for erector spinae block

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

Group Type ACTIVE_COMPARATOR

Ropivacaine (0.5% bolus followed by 0.2% infusion)

Intervention Type DRUG

Continuous catheter infusion for erector spinae plane block

Interventions

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Liposomal Bupivacaine (EXPAREL®)/Bupivacaine

Single shot for erector spinae block

Intervention Type DRUG

Ropivacaine (0.5% bolus followed by 0.2% infusion)

Continuous catheter infusion for erector spinae plane block

Intervention Type DRUG

Other Intervention Names

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EXPAREL®/Bupivacaine Ropivacaine

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poovendran Saththasivam

OTHER

Sponsor Role lead

Responsible Party

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Poovendran Saththasivam

Sponsor-Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Poovendran Saththasivam, MD

Role: PRINCIPAL_INVESTIGATOR

The Guthrie Clinic

Locations

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Robert Packer Hospital

Sayre, Pennsylvania, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2007-48

Identifier Type: -

Identifier Source: org_study_id

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