Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

Pain, Postoperative Clinical Trial

Official title:

Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384664
• Other study ID #: HUM00241242
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 20, 2024
• Est. completion date: April 2028

Study information

• Verified date: May 2024
• Source: University of Michigan
• Contact: Shari L Barnett
• Phone: 734-936-4561
• Email: shbailey[@]umich.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The researchers will compare the common methods of post-surgical pain control, such as epidural or intercostal nerve block with a newer method called cryoablation. The research team is conducting this study to determine if cryoablation provides more effective pain control when compared to an epidural or intercostal nerve block.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: April 2028
• Est. primary completion date: April 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who could receive cryoablation in an elective open thoracic (posterolateral thoracotomy) or minimally invasive (thoracoscopy, including robotic) procedures at Michigan Medicine

• Patient is opioid naïve

Exclusion Criteria:

• Patients who are pregnant

• Patients with cognitive impairment

• Patients with psychological disorders

• Patients with prior thoracic surgery

• Patients with fibromyalgia

• Patients with redo ipsilateral thoracic surgery

• Patients undergoing bilateral thoracotomy

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative

Intervention

Device:
• Atricure's crysoSPHERE probe
Cryoablation is a procedure that is used to freeze and burn away tissue cells via a device called a cryosphere which emits a freezing gas.

Procedure:
• Standard of Care
An intercostal nerve block involves injecting anesthetic medications into nerves around the thoracic incision to provide temporary longer term pain relief after surgery.

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan

Sponsors (2)

Lead Sponsor	Collaborator
University of Michigan	AtriCure, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complications following surgery	Any unexpected or unanticipated incidents, symptoms or medical issues following surgery	Up to 180-days following surgery
Other	Length of stay	length of hospital stay	Up to hospital discharge, approximately 3 days
Other	Time to ambulation	Day of first ambulation documented	Up to 180-days following surgery
Other	Chronic Pain medication use through 6 months		Up to 180-days after surgery
Other	Chronic pain through 6 months.	Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Intensity survey	Up to 180-days after surgery
Other	Chronic pain through 6 months.	Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Pain Interference survey	Up to 180-days after surgery
Other	Chronic pain through 6 months.	Chronic pain is defined as pain that lasts for over three months as assessed by the PROMIS Neuropathic Pain Quality Survey	Up to 180-days after surgery
Other	Incentive spirometry volumes in the peri-operative period (POD 1 and 2)		Postop day 1 and 2
Other	Oxygen requirement	documentation of oxygen use	Up to 180-days postop
Other	Hospital charges and hospital reimbursement by different payors		Up to 180-days postop
Primary	Severity of pain in the peri-operative period	Pain measured using a numeric rating scale ranging from 1-10 where a higher pain score indicates more pain severity	Post-op day 1 and day of hospital discharge, approximately 3 days
Primary	Inflammatory cytokine levels as measured by blood samples	Levels are measured using blood sample collection and assay specifically assessing IL-1, IL-6, TNF-a	Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Primary	Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score	Correlations with the pain scores from outcome #1	Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
Primary	Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)	Measured using the Patient-Reported Outcomes Measurement Information System (PROMIS) pain intensity surveys	baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
Primary	Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)	assessment of feeling or touching sensations along the thoracic cavity measured using dermatone assessment	baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
Secondary	Quality of life score as measured by SF-36 Health questionnaire	36 item survey instrument	baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.
Secondary	Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)	Hospital charges for cases that get standard of care postop pain management versus cases that receive cryoablation.	Up to 180-days postop
Secondary	Workflow/time	Including items such as length of operating room use and length of hospital stay	Up to 180-days postop