Chronic Post-thoracotomy PainICENCT03538340
Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy
A study testing Thoracic Epidural and Intercostal Cryoanalgesia in people with Chronic Post-thoracotomy Pain and Acute Post-thoracotomy Pain, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Post-thoracotomy Pain, Acute Post-thoracotomy Pain, Post-thoracotomy Pain Syndrome
- What is being tested?
- Thoracic Epidural and Intercostal Cryoanalgesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2018to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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 locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Maryland Medical Center
Baltimore, Maryland, 21201
Melissa Culligan, RN, MS, 215-570-0854, mculligan@som.umaryland.edu
About this study
Official title: Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study
The ICE Study study will compare standard therapy (thoracic epidural) versus a novel approach (Cryoanalgesia combined with thoracic epidural) in subjects undergoing unilateral thoracotomy.
Read the 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.
- Conditions
- Chronic Post-thoracotomy Pain, Acute Post-thoracotomy Pain, Post-thoracotomy Pain Syndrome
- Being tested
- Thoracic Epidural, Intercostal Cryoanalgesia
- Keywords
- Thoracotomy, Cryoanalgesia, Pain
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thoracic EpiduralProcedure or surgery
The control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural
Intercostal CryoanalgesiaProcedure or surgery
The study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia
| Study group | Role | What they receive |
|---|---|---|
| Control Arm | Active comparator | Control Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural) Receives: Procedure: Thoracic Epidural |
| Study Arm | Experimental | Study Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural) Receives: Procedure: Thoracic Epidural; Procedure: Intercostal Cryoanalgesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total narcotic use post-thoracotomy.
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.
Measured: 6 months
Secondary outcomes (4)
Visual Analog Scale (VAS) Assessment of post-thoracotomy pain
Visual Analog Scale will be used to assess pain levels (0-10 range scale with 0=no pain and 10= worse pain ever
Measured: 6 months
Quality of Life (SF-36) changes from baseline to 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
Measured: 6 months
Allodynia Assessment
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
Measured: 6 months
Mankoski Pain Scale Assessment of post-thoracotomy pain
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start1 Sep 2018
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Post-thoracotomy PainStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Collaborators
- AtriCure, Inc.
- Responsible party
- Principal investigator, Joseph S. Friedberg, MD, University of Maryland, Baltimore
- Investigators
- Joseph S Friedberg, MD, Principal investigator, U Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03538340
- Sponsor's protocol ID
- HP-00079115
- Acronym
- ICE
- Status last verified
- Apr 2021
- First submitted
- 7 Mar 2018
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Single-Blinded, Controlled Trial Using Intraoperative Cryoanalgesia for Extended Pain Management Following Thoracotomy: ICE Study
- ClinicalTrials.gov ID
- NCT03538340
- Acronym / sponsor ID
- ICE / HP-00079115
- Conditions
- Chronic Post-thoracotomy Pain, Acute Post-thoracotomy Pain, Post-thoracotomy Pain Syndrome
- Keywords
- Thoracotomy, Cryoanalgesia, Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Collaborators
- AtriCure, Inc.
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Jan 2023 (estimated)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Arm | Active comparator | Procedure: Thoracic EpiduralControl Arm: Surgery without intercostal Cryoanalgesia + Standard of Care (thoracic epidural) |
| Study Arm | Experimental | Procedure: Thoracic Epidural, Procedure: Intercostal CryoanalgesiaStudy Arm: Surgery with intercostal Cryoanalgesia + Standard of Care (thoracic epidural) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thoracic EpiduralThe control arm will receive standard of care pain management which includes a Thoracic Patient Controlled Epidural | Procedure or surgery | Control Arm, Study Arm |
| Intercostal CryoanalgesiaThe study arm will receive standard of care pain management which includes a Thoracic Epidural plus Intraoperative Intercostal Cryoanalgesia | Procedure or surgery | Study Arm |
Primary outcome
Total narcotic use post-thoracotomy.
Time frame: 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.
4 secondary outcomes
Visual Analog Scale (VAS) Assessment of post-thoracotomy pain
Time frame: 6 months
Quality of Life (SF-36) changes from baseline to 6-months
Time frame: 6 months
Allodynia Assessment
Time frame: 6 months
Mankoski Pain Scale Assessment of post-thoracotomy pain
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joseph S Friedberg, MD principal investigator
U Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thoracic Epidural and Intercostal Cryoanalgesia in people with Chronic Post-thoracotomy Pain and Acute Post-thoracotomy Pain, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Melissa Culligan, RN, MS (410-328-6366, mculligan@som.umaryland.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total narcotic use post-thoracotomy. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.