Clinical trial NCT06384664: Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
Official title: Cryoablation Effects on Acute and Chronic Pain After Thoracotomy and Thoracoscopy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Pain, Postoperative
Intrathoracic Procedure
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
First posted: 2024-04-25
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Severity of pain in the peri-operative period
timeFrame: Post-op day 1 and day of hospital discharge, approximately 3 days
measure: Inflammatory cytokine levels as measured by blood samples
timeFrame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
measure: Inflammatory cytokines (IL-1, IL-6, TNF-a) levels correlations to pain score
timeFrame: Pre-surgery, 6-hours after end of surgery and 24-hours after surgery
measure: Peri-operative pain scores between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
timeFrame: baseline (pre-op), post-op day 1, day of hospital discharge, approximately 3 days, 2-weeks postop and 30-, 90-, and 180-days postop
measure: Peri-operative nerve function between different surgical incisions (posterolateral thoracotomy vs thoracoscopy)
timeFrame: 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 outcomes:
measure: Quality of life score as measured by SF-36 Health questionnaire
timeFrame: baseline (prior to surgery), day of hospital discharge, approximately 3 days, 30-days, 90-days and 180-days post-op.
measure: Cost (including postoperative epidural management, narcotic pain medication, and outpatient pain management)
timeFrame: Up to 180-days postop
measure: Workflow/time
timeFrame: Up to 180-days postop
Other outcomes:
measure: Complications following surgery
timeFrame: Up to 180-days following surgery
measure: Length of stay
timeFrame: Up to hospital discharge, approximately 3 days
measure: Time to ambulation
timeFrame: Up to 180-days following surgery
measure: Chronic Pain medication use through 6 months
timeFrame: Up to 180-days after surgery
measure: Chronic pain through 6 months.
timeFrame: Up to 180-days after surgery
measure: Chronic pain through 6 months.
timeFrame: Up to 180-days after surgery
measure: Chronic pain through 6 months.
timeFrame: Up to 180-days after surgery
measure: Incentive spirometry volumes in the peri-operative period (POD 1 and 2)
timeFrame: Postop day 1 and 2
measure: Oxygen requirement
timeFrame: Up to 180-days postop
measure: Hospital charges and hospital reimbursement by different payors
timeFrame: Up to 180-days postop
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Rishindra Reddy, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References: