Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy

Not Applicable

• Conditions: Acute Post-thoracotomy Pain; Chronic Post-thoracotomy Pain; Post-thoracotomy Pain Syndrome
• Interventions: Procedure: Thoracic Epidural; Procedure: Intercostal Cryoanalgesia

• Registration Number: NCT03538340
• Lead Sponsor: University of Maryland, Baltimore

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.

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 Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-05-15
• Study First Posted: 2018-05-29
• Study Start: 2018-09-01
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-27
• Primary Completion: 2022-12-31
• Study Completion: 2023-01-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Arm	Thoracic Epidural	Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural)
Study Arm	Intercostal Cryoanalgesia	Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)
Study Arm	Thoracic Epidural	Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural)

Primary Outcome Measures

Name	Time	Method
Total narcotic use post-thoracotomy.	6 months	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.

Secondary Outcome Measures

Name	Time	Method
Quality of Life (SF-36) changes from baseline to 6-months	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
Allodynia Assessment	6 months	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
Mankoski Pain Scale Assessment of post-thoracotomy pain	6 months	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
Visual Analog Scale (VAS) Assessment of post-thoracotomy pain	6 months	Visual Analog Scale will be used to assess pain levels (0-10 range scale with 0=no pain and 10= worse pain ever

Trial Locations

Locations (1)

University of Maryland Medical Center; 🇺🇸 Baltimore, Maryland, United States