search
Back to results

Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

Primary Purpose

Pain, Postoperative, Lung Cancer

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Bupivacaine liposome
Bupivacaine / Epinephrine
Sponsored by
University of Tennessee
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring bupivacaine, lipossomal extended release bupivacaine, Intercostal nerve block, thoracic surgery, minimally invasive surgery

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Patients who will be undergoing minimally invasive thoracic surgery

  • 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

Sites / Locations

  • Methodist University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Bupivacaine with epinephrine

Lipossomal extended release bupivacaine

Arm Description

Patients will receive intraoperative intercostal nerve block with bupivacaine

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

Outcomes

Primary Outcome Measures

Postoperative pain
Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.

Secondary Outcome Measures

Postoperative complications
Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.
Narcotic used
Amount of morphine equivalent dosage used in the postoperative period

Full Information

First Posted
June 6, 2018
Last Updated
June 18, 2018
Sponsor
University of Tennessee
search

1. Study Identification

Unique Protocol Identification Number
NCT03560362
Brief Title
Postoperative Pain Control With Lipossomic Extended Release Bupivacaine
Official Title
Randomized Trial Comparing Bupivacaine vs Lipossomic Extended Release Bupivacaine for Postoperative Pain Control After Minimally Invasive Thoracic Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
July 9, 2015 (Actual)
Primary Completion Date
October 31, 2018 (Anticipated)
Study Completion Date
October 31, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Tennessee

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Randomized trial of intraoperative intercostal block with bupivacaine with epinephrine compared to lipossomal extended release bupivacaine.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Lung Cancer
Keywords
bupivacaine, lipossomal extended release bupivacaine, Intercostal nerve block, thoracic surgery, minimally invasive surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine with epinephrine
Arm Type
Active Comparator
Arm Description
Patients will receive intraoperative intercostal nerve block with bupivacaine
Arm Title
Lipossomal extended release bupivacaine
Arm Type
Experimental
Arm Description
Patients will receive intraoperative intercostal nerve block with lipossomal extended release bupivacaine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine liposome
Intervention Type
Drug
Intervention Name(s)
Bupivacaine / Epinephrine
Primary Outcome Measure Information:
Title
Postoperative pain
Description
Pain assessment with Visual Analog Scale (VAS). This is a numeric pain scale widely used in healthcare that ranks pain from 0 (no pain) to 10 (unbearable pain). A pain score below 3 is considered good.
Time Frame
3-5 days post op
Secondary Outcome Measure Information:
Title
Postoperative complications
Description
Any complication occuring in the first 90 days classified according to the Clavien-Dindo classification.
Time Frame
90 days post op
Title
Narcotic used
Description
Amount of morphine equivalent dosage used in the postoperative period
Time Frame
3-5 days post op

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who will be undergoing minimally invasive thoracic surgery 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Benny Weksler, MD
Phone
901-448-2918
Email
bweksler@uthsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Suzie Glass, RN
Phone
901-448-2918
Email
Suzie.Glass@mlh.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benny Weksler, MD
Organizational Affiliation
University of Tennessee
Official's Role
Principal Investigator
Facility Information:
Facility Name
Methodist University Hospital
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benny Weksler
Phone
901-448-2918
Email
bweksler@uthsc.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Postoperative Pain Control With Lipossomic Extended Release Bupivacaine

We'll reach out to this number within 24 hrs