Recruiting

Cryoanalgesia

Sponsor:

University of Maryland, Baltimore

Code:

NCT03538340

Conditions

Chronic Post-thoracotomy Pain

Acute Post-thoracotomy Pain

Post-thoracotomy Pain Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Thoracic Epidural

Intercostal Cryoanalgesia

Study Details

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.

Conditions

Chronic Post-thoracotomy Pain

Acute Post-thoracotomy Pain

Post-thoracotomy Pain Syndrome

Study ID

NCT03538340

Start date

Sep 1, 2018

Status verified date

Apr, 2021

Completion date

Jan 31, 2023

Anticipated

Primary completion date

Dec 31, 2022

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

138 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Control Arm

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

experimental: Study Arm

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

Interventions

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

Primary outcome measure

  • Total narcotic use post-thoracotomy. [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Melissa Culligan, RN, MS

410-328-6366mculligan@som.umaryland.edu

Locations

University of Maryland Medical Center

Recruiting

Baltimore, Maryland, United States, 21201

Contacts

Melissa Culligan, RN, MS

215-570-0854mculligan@som.umaryland.edu

More Information

Sponsor

University of Maryland, Baltimore

Last update posted

Apr 27, 2021

Last verified

Apr, 2021

Keywords

  • Thoracotomy
  • Cryoanalgesia
  • Pain

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Maryland, Baltimore on 2021-04-27.