Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

Post-thoracotomy Pain Syndrome Clinical Trial

— ICE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03538340
• Other study ID #: HP-00079115
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: January 31, 2023

Study information

• Verified date: April 2021
• Source: University of Maryland, Baltimore
• Contact: Melissa Culligan, RN, MS
• Phone: 410-328-6366
• Email: mculligan[@]som.umaryland.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 138
• Est. completion date: January 31, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Post-thoracotomy Pain
• Chronic Post-thoracotomy Pain
• Post-thoracotomy Pain Syndrome

Intervention

Procedure:
• Thoracic Epidural
The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural
• Intercostal Cryoanalgesia
The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia

Locations

Country	Name	City	State
United States	University of Maryland Medical Center	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
University of Maryland, Baltimore	AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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