NCT03538340

Brief Summary

The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.

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
138

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

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

First Submitted

Initial submission to the registry

March 7, 2018

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2023

Completed
Last Updated

April 27, 2021

Status Verified

April 1, 2021

Enrollment Period

4.3 years

First QC Date

March 7, 2018

Last Update Submit

April 23, 2021

Conditions

Chronic Post-thoracotomy PainAcute Post-thoracotomy PainPost-thoracotomy Pain Syndrome

Keywords

ThoracotomyCryoanalgesiaPain

Outcome Measures

Primary Outcomes (1)

  • Total narcotic use post-thoracotomy.

    The primary outcome measure of this study is to determine if the addition of Cryoanalgesia to standard of care post thoracotomy pain control, results in decreased pain and/or narcotic use at time points ranging from perioperative to six months post discharge.

    6 months

Secondary Outcomes (4)

  • Visual Analog Scale (VAS) Assessment of post-thoracotomy pain

    6 months

  • Quality of Life (SF-36) changes from baseline to 6-months

    6 months

  • Allodynia Assessment

    6 months

  • Mankoski Pain Scale Assessment of post-thoracotomy pain

    6 months

Study Arms (2)

Control Arm

ACTIVE COMPARATOR

Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural)

Procedure: Thoracic Epidural

Study Arm

EXPERIMENTAL

Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)

Procedure: Thoracic EpiduralProcedure: Intercostal Cryoanalgesia

Interventions

Thoracic EpiduralPROCEDURE

The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural

Control ArmStudy Arm
Intercostal CryoanalgesiaPROCEDURE

The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia

Study Arm

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing unilateral thoracotomy for non-cardiac surgery
  • Age 18-85 years of age; male or female
  • Acceptable surgical candidate including use of general anesthesia
  • Willing and able to provide written informed consent
  • Willing and able to return for scheduled follow-up visits

You may not qualify if:

  • Prior major surgery within the last 6-months
  • Documented psychiatric disease
  • Documented chronic pain syndrome
  • Current use of prescription opioids
  • Documented history of substance abuse
  • Functional disability or impairment (ECOG score = 0 or 1)
  • Current pregnancy
  • Patients currently enrolled in another research study that could directly affect results of either study
  • Physical or mental condition that would interfere with patient's self-assessment of pain
  • A medical condition that in the investigator's opinion could adversely impact the patient's participation or safety, conduct of the study or interferes with the pain assessments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland Medical Center

Baltimore, Maryland, 21201, United States

RECRUITING

MeSH Terms

Conditions

Pain

Interventions

Tea

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Plant PreparationsBiological ProductsComplex MixturesBeveragesDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Joseph S Friedberg, MD

    U Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Melissa Culligan, RN, MS

CONTACT

410-328-6366mculligan@som.umaryland.edu

Study Design

Study Type
interventional
Phase
not applicable
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
Professor; Surgeon-in-Chief, UMMS Division of Thoracic Surgery

Study Record Dates

First Submitted

March 7, 2018

First Posted

May 29, 2018

Study Start

September 1, 2018

Primary Completion

December 31, 2022

Study Completion

January 31, 2023

Last Updated

April 27, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)