Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy (ICE)

University of Maryland Baltimore (UMB)

Status: Unknown

Conditions: Chronic Post-thoracotomy Pain; Post-thoracotomy Pain Syndrome; Acute Post-thoracotomy Pain

Treatments: Procedure: Thoracic Epidural; Procedure: Intercostal Cryoanalgesia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03538340

HP-00079115

Details and patient eligibility

About

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

Full 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.

Enrollment: 138 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

138 participants in 2 patient groups

Control Arm

Active Comparator group

Description:

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

Treatment:

Procedure: Thoracic Epidural

Study Arm

Experimental group

Description:

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

Treatment:

Procedure: Intercostal Cryoanalgesia

Procedure: Thoracic Epidural