NCT02005575

Brief Summary

The proposed study is a randomized, double-blinded, non-placebo-controlled evaluation of the effect of the addition of dexamethasone to intraoperative intercostal nerve block bupivicaine solutions on the duration of pain relief and post operative pulmonary function.

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 P25-P50 for phase_4

Timeline
Completed

Started Oct 2013

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

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2013

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2015

Completed
Last Updated

February 4, 2015

Status Verified

February 1, 2015

Enrollment Period

1.4 years

First QC Date

November 5, 2013

Last Update Submit

February 2, 2015

Conditions

Post Minimally Invasive Thorascopic Surgical Pain

Outcome Measures

Primary Outcomes (1)

  • Post operative pain

    Patients will be evaluated for post operative pain using the NRS pain evaulation

    72 hours post operatively

Study Arms (2)

Group 1

PLACEBO COMPARATOR

an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml normal saline)

Drug: Placebo

Group 2

ACTIVE COMPARATOR

an intercostal nerve block with a solution consisting of 0.46% bupivicaine (19.5 ml of 0.5% bupivicaine + .5ml .4% dexamethasone)

Drug: Bupivacaine and Dexamethasone

Interventions

Bupivacaine and DexamethasoneDRUG

The standard of care is to use a regional block solution containing both decadron and bupivicaine.

Also known as: Decadron
Group 2
PlaceboDRUG
Group 1

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years old of either gender, scheduled for unilateral VATS procedure with Dr. McKenna for resection of lung tumor.

You may not qualify if:

  • ASA IV and above
  • Intolerance, allergy, or contraindication to use of any medications used in this study
  • Significant coronary artery disease (abnormal stress test, myocardial infarction within the last 3 months)
  • Uncontrolled hypertension (BP \> 140/90)
  • History of prior ipsilateral thorascopic surgery
  • Cardiac arrhythmias particularly prolonged QT syndrome
  • Drugs known to cause prolonged qT: class IA antiarrhythmics (quinidine, procainamide, dysopyramide), class III antiarrhythmics (sotalol, dofetalide, ibutalide, amiodarone), haloperidol, thioridazine, arsenic trioxide, HIV protease inhibitors, tricyclic antidepressants
  • Individuals with significant psychological disorders including: schizophrenia, mania, bipolar disorder or psychosis
  • Pregnant or lactating women
  • Morbid obesity (BMI \> 40 kg/m2) AND/OR weight \> 150 kg
  • Chronic renal failure ( creatinine \> 2.0 mg/dL)
  • Liver failure e.g., active cirrhosis
  • Alcohol or substance abuse within in the past 3 months
  • Uncorrected hypokalemia, hypomagnesemia, hypocalcemia (can be due to diuretics, mineralocorticoid use, laxatives)
  • Restrictive lung disease (pulmonary fibrosis, myasthenia gravis) or FEV1 or FEV less than 70% of predicted value.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cedars Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Interventions

BupivacaineDexamethasoneCalcium Dobesilate

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, FluorinatedBenzenesulfonatesBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsArylsulfonatesArylsulfonic AcidsSulfonic AcidsSulfur AcidsSulfur Compounds

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Department of Anesthesia

Study Record Dates

First Submitted

November 5, 2013

First Posted

December 9, 2013

Study Start

October 1, 2013

Primary Completion

March 1, 2015

Study Completion

March 1, 2015

Last Updated

February 4, 2015

Record last verified: 2015-02

Locations

US(1)