Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

NCT ID: NCT03560362

Last Updated: 2018-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-09

Study Completion Date

2018-10-31

Brief Summary

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Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.

Detailed Description

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Patients undergoing minimally invasive thoracic surgery will be randomized to receive 0.05% bupivacaine with 1:200,000 epinephrine (control group) or extended release lipossomal bupivacaine. Primary outcomes are postoperative pain measured by visual analog scale, amount of morphine equivalent narcotics used, and postoperative complications. Patients are excluded if they undergo open thoracotomy, or minimally invasive decortication.

Conditions

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Pain, Postoperative Lung Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Bupivacaine with epinephrine

Patients will receive intraoperative intercostal nerve block with bupivacaine

Group Type ACTIVE_COMPARATOR

Bupivacaine / Epinephrine

Intervention Type DRUG

Lipossomal extended release bupivacaine

Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine

Group Type EXPERIMENTAL

Bupivacaine liposome

Intervention Type DRUG

Interventions

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Bupivacaine liposome

Intervention Type DRUG

Bupivacaine / Epinephrine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who will be undergoing minimally invasive thoracic surgery

Exclusion Criteria

* Open surgery
* Chronic use of narcotics
* Use of pregabalin or similar
* Significant liver or kidney dysfunction
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Tennessee

OTHER

Sponsor Role lead

Responsible Party

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Benny Weksler

Professor of Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Benny Weksler, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tennessee

Locations

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Methodist University Hospital

Memphis, Tennessee, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Benny Weksler, MD

Role: CONTACT

901-448-2918

Suzie Glass, RN

Role: CONTACT

901-448-2918

Facility Contacts

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Benny Weksler

Role: primary

901-448-2918

Other Identifiers

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15-03838

Identifier Type: -

Identifier Source: org_study_id

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