Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy (ICE)

Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study

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

Study Overview

• Status: Recruiting
• Conditions: Chronic Post-thoracotomy Pain; Post-thoracotomy Pain Syndrome; Acute Post-thoracotomy Pain
• Intervention / Treatment: Procedure: Thoracic Epidural; Procedure: Intercostal Cryoanalgesia

Detailed Description

The ICE Study is a single institution pilot study designed to compare standard therapy (i.e., thoracic epidural) versus a novel approach (i.e., Cryoanalgesia combined with thoracic epidural) to address the need for better management of acute and long-term pain in the general thoracic surgery patient population. The study's primary objective will be to demonstrate if the new intraoperative pain management approach [i.e., intercostal Cryoanalgesia in conjunction with thoracic epidural] provides superior short-term and long-term analgesia efficacy in patients undergoing unilateral thoracotomy as compared to the current institutional standard of care (i.e., thoracic epidural). Patients will be randomized in a 1:1 design.

• Study Type: Interventional
• Enrollment (Anticipated): 138
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Melissa Culligan, RN, MS; Phone Number: 410-328-6366; Email: mculligan@som.umaryland.edu

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Recruiting
      • University of Maryland Medical Center
      • Contact: Melissa Culligan, RN, MS; Phone Number: 215-570-0854; Email: mculligan@som.umaryland.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control Arm; Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural)	Procedure: Thoracic Epidural; The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural
Experimental: Study Arm; Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)	Procedure: Thoracic Epidural; The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural; Procedure: Intercostal Cryoanalgesia; The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale (VAS) Assessment of post-thoracotomy pain	Visual Analog Scale will be used to assess pain levels (0-10 range scale with 0=no pain and 10= worse pain ever	6 months
Quality of Life (SF-36) changes from baseline to 6-months	Assessment of the impact of pain on quality of life (questions using varied assessment scales: rating general health from excellent to poor; yes-no; none to very severe; not at all to extremely; all of the time to none of the time; true-false	6 months
Allodynia Assessment	Allodynia screening and assessments will assess the levels of skin hypersensitivity associated with neuropathic pain following thoracotomy and will be performed at predetermined time points	6 months
Mankoski Pain Scale Assessment of post-thoracotomy pain	Mankoski Pain Scale will be used to assess pain levels (scale ranging from 0 to 10 with 0 = no pain to 10 = worse pain ever	6 months

Collaborators and Investigators

• Sponsor: University of Maryland, Baltimore
• Collaborators: AtriCure, Inc.
• Investigators: Principal Investigator: Joseph S Friedberg, MD, U Maryland, Baltimore

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): January 31, 2023

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: May 15, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): April 27, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Pain; Thoracotomy; Cryoanalgesia
• Other Study ID Numbers: HP-00079115

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes