NCT03560362

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jul 2015

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 9, 2015

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

June 20, 2018

Status Verified

June 1, 2018

Enrollment Period

3.3 years

First QC Date

June 6, 2018

Last Update Submit

June 18, 2018

Conditions

Pain, PostoperativeLung Cancer

Keywords

bupivacainelipossomal extended release bupivacaineIntercostal nerve blockthoracic surgeryminimally invasive surgery

Outcome Measures

Primary Outcomes (1)

  • 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.

    3-5 days post op

Secondary Outcomes (2)

  • Postoperative complications

    90 days post op

  • Narcotic used

    3-5 days post op

Study Arms (2)

Bupivacaine with epinephrine

ACTIVE COMPARATOR

Patients will receive intraoperative intercostal nerve block with bupivacaine

Drug: Bupivacaine / Epinephrine

Lipossomal extended release bupivacaine

EXPERIMENTAL

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

Drug: Bupivacaine liposome

Interventions

Bupivacaine liposomeDRUG
Lipossomal extended release bupivacaine
Bupivacaine / EpinephrineDRUG
Bupivacaine with epinephrine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients who will be undergoing minimally invasive thoracic surgery

You may not qualify if:

  • Open surgery
  • Chronic use of narcotics
  • Use of pregabalin or similar
  • Significant liver or kidney dysfunction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Methodist University Hospital

Memphis, Tennessee, 38104, United States

RECRUITING

MeSH Terms

Conditions

Pain, PostoperativeLung Neoplasms

Interventions

BupivacaineEpinephrine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsRespiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesEthanolaminesAmino AlcoholsAlcoholsBiogenic MonoaminesBiogenic AminesCatecholaminesCatecholsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Study Officials

  • Benny Weksler, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Benny Weksler, MD

CONTACT

901-448-2918bweksler@uthsc.edu

Suzie Glass, RN

CONTACT

901-448-2918Suzie.Glass@mlh.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Surgery

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 18, 2018

Study Start

July 9, 2015

Primary Completion

October 31, 2018

Study Completion

October 31, 2018

Last Updated

June 20, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)