Cryotherapy EffectNCT05255146
Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
A study testing Atricure Inc. Nitrous oxide Cryoprobe in people with Cryotherapy Effect and Post Operative Pain, run by University of Alberta.
Trial summary
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection. This is thought to be because of damage to the intercostal nerves by compression and traction by the surgical equipment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryotherapy Effect, Post Operative Pain
- What is being tested?
- Atricure Inc. Nitrous oxide Cryoprobe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2025to 4 May 2026
- 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
- Adult patients aged 18 years or older scheduled for elective minimally invasive mitral valve surgery or atrial septal defect repair.
Who cannot join
- Patients will be excluded if they are unable to fill in detailed health and pain related questionnaires, psychiatric disease preventing recall or accurate descriptions of pain, chronic pain syndromes, alcohol or illegal substance abuse, or pregnancy. Exclusion criteria also includes chronic use of opioids, allergy to morphine, bupivacaine, and/or ibuprofen, average pain during the last week >4 on a numerical rating scale from 0 to 10 with 0 indicating "no pain" and 10 indicating "the worst pain imaginable", contraindications to thoracic epidurals, prior chest surgery, or participation in another clinical trial.
About this study
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection. This is thought to be because of damage to the intercostal nerves by compression and traction by the surgical equipment. Cryoanalgesia is long-standing technique that freezes nerves locally to temporarily block pain sensation, which is currently used to treat acute post-operative pain in lung dissections and the Nuss procedure. We intend to perform a trial to assess whether using cryoanalgesia on intercostal nerves intraoperatively, reduces post-operative pain following minimally invasive cardiothoracic surgery.
Read the detailed description
Objective:
To characterize the effects of peri-operative intercostal cryoablation for the prevention of post thoracotomy pain following minimally invasive mitral valve surgery or atrial septal defect repair.
Rationale:
Minimally invasive cardiothoracic surgery is often associated with prolonged post-operative neuropathic pain not consistent with the acute pain experience of the initial surgery [1]. This is often thought to be secondary to an intercostal neuralgia caused by traction injuries to the intercostal neurovascular bundles by the surgical ports, a mini-thoracotomy, and mechanical retraction of the ribs.
Cryoanalgesia is an older but clinically relevant technique that causes local destruction of nerve axons using a nitrous oxide-cooled probe to -60°C [2]. This allows for temporary acute pain relief without damaging the endoneurium, allowing the peripheral nerves to regrow post-operatively. Previous studies have demonstrated cryoanalgesia as having improved acute post-operative pain vs opioids alone or similar acute pain management vs epidural analgesia [3,4]. A few studies have assessed Cryoanalgesia in thoracic surgery patients; however, these studies have focused primarily on lung operations involving pulmonary resections, and did not include cardiac operations [5,6]. Furthermore, studies that evaluated cardiothoracic operations specifically, were either retrospective or prospective in approach and did not include a representative variety of cardiac operations [7-9]. Therefore, we hope that by using intercostal cryoablation in minimally invasive cardiac surgery patients, we might improve post-operative pain and reduce analgesic requirements.
Sample Size and Statistical Considerations:
Analyses will be conducted on an intention-to-treat basis. Relative and absolute risk will be calculated with respect to the primary and secondary outcomes. We calculate a sample size of 50 patients per group in order to detect a reduction in incidence of post-thoracotomy pain from 50% to 20% (α=0.05, power=0.8). This includes an anticipated rate of non-completion of 15%.
Expected Results:
Based on our hypotheses and previous human RCT's, we expect intercostal cryoablation to improve post-thoracotomy pain when compared to controls. Furthermore, we expect an improvement in our secondary outcomes including sleep quality and analgesic requirements. Cryoanalgesia's efficacy in acute post-operative pain management is well documented in the neuropathic pain literature and has been used in a number of clinical trials. We hope that applying this concept to minimally invasive cardiothoracic procedures, we can see similar results in improved post-thoracotomy pain as reported by previous studies. We believe that, if successful, this project will offer an alternative and improved pain management regimen for patients undergoing minimally invasive thoracic surgery.
Significance:
The study proposed aims to provide new insight into the management of neuropathic pain associated with minimally invasive thoracic surgery. Pain -whether acute, chronic, nociceptive, or neuropathic- creates a significant burden to the patient, as well as to those around them. Our ultimate aim is to limit the overall pain experienced by patients. In doing this, we hope to influence a multitude of factors that affect patient welfare, including mood, patient safety, return to independence, return to work, etc. Many of these factors are often much more subjective and difficult to capture within the analytical framework of a clinical trial. However, it is our hope that by reducing pain, itself, we can continue to improve patient satisfaction and consequently, patient well-being.
- Conditions
- Cryotherapy Effect, Post Operative Pain
- Being tested
- Atricure Inc. Nitrous oxide Cryoprobe
- Keywords
- Minimally Invasive cardiac surgery, cryoanalgesia, mitral valve surgery, ASD repair, thoracotomy, pain management
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atricure Inc. Nitrous oxide CryoprobeDevice
Cryoanalgesia will be given by applying a nitrous oxide-cooled probe (AtriCure, Inc. 2000) locally to intercostal nerves in the 4th, 5th, and 6th rib spaces after completion of the surgical repair and before surgical closure. The probe will be cooled to -60°C and held on each location for 60 sec.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group: Cryoanalgesia | Experimental | Patients receiving cryoanalgesia peri-operatively during minimally invasive cardiothoracic surgery Receives: Device: Atricure Inc. Nitrous oxide Cryoprobe |
| Control Group: No Cyroanalgesia | No intervention | Patients receiving minimally invasive cardiothoracic surgery who do not receive cryoanalgesia. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative Pain Day 1
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Measured: 1 day post-op
Post-operative Pain Day 3
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Measured: 3 days post-op
Post-operative Pain Day 5
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Measured: 5 days post-op
Long-term Post-operative Pain
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory by asking the participants via phone call.
Measured: 6 weeks post-op
Secondary outcomes (6)
Sleep Quality
Average sleep quality will be assessed by asking participants to rate their sleep over the first post-operative that they spent in-hospital. This will be scored numerically from 0 to 10, with 0 indicating extremely poor sleep quality and 10 indicating extremely good sleep quality.
Measured: 1 week post-op
Consumptions of Analgesics Day 1
Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted.
Measured: 1 day post-op
Consumptions of Analgesics Day 3
Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted.
Measured: 3 days post-op
Consumptions of Analgesics Day 5
Average daily consumption of analgesics, adjusted to morphine equivalents, will be collected from patient chart information while they are admitted.
Measured: 5 Days post-op
Long-term Consumptions of Analgesics
Average daily consumption of analgesics, adjusted to morphine equivalents, over the 7 days prior to assessment.
Measured: 6 weeks post-op
Length of Hospital Stay
Hospital length of stay, measured in days, will be determined by their discharge date post-operatively and their date of admission.
Measured: approximately 2 weeks post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2022
- Study startSep 2025 (estimated)
- Primary completion4 May 2026
- Study completion4 May 2026
Why it stopped: Logistical Issues; study never started up
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Cryotherapy EffectStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a pilot, randomized, double-blinded, placebo-controlled trial evaluating the effect of intercostal cyroablation on the development of post-thoracotomy pain. With the use of computer-generated randomized blocks, patients will be assigned to either Cryoanalgesia or no-cryoanalgesia before undergoing surgery.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abeline R Watkins, BSc, Principal investigator, UofA Research/Department of Cardiac SurgeryAndrew O'Connell, MD, Principal investigator, UofA Department of Cardiac Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05255146
- Sponsor's protocol ID
- Pro00113974
- Status last verified
- May 2026
- First submitted
- 31 Jan 2022
- Last updated
- 8 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Guastella V, Mick G, Soriano C, Vallet L, Escande G, Dubray C, Eschalier A. A prospective study of neuropathic pain induced by thoracotomy: incidence, clinical description, and diagnosis. Pain. 2011 Jan;152(1):74-81. doi: 10.1016/j.pain.2010.09.004. Epub 2010 Nov 13.
PubMed 21075523Muller LC, Salzer GM, Ransmayr G, Neiss A. Intraoperative cryoanalgesia for postthoracotomy pain relief. Ann Thorac Surg. 1989 Jul;48(1):15-8. doi: 10.1016/0003-4975(89)90169-0.
PubMed 2764595Ju H, Feng Y, Yang BX, Wang J. Comparison of epidural analgesia and intercostal nerve cryoanalgesia for post-thoracotomy pain control. Eur J Pain. 2008 Apr;12(3):378-84. doi: 10.1016/j.ejpain.2007.07.011. Epub 2007 Sep 17.
PubMed 17870625Park R, Coomber M, Gilron I, Shanthanna H. Cryoanalgesia for postsurgical pain relief in adults: A systematic review and meta-analysis. Ann Med Surg (Lond). 2021 Aug 5;69:102689. doi: 10.1016/j.amsu.2021.102689. eCollection 2021 Sep.
PubMed 34408872Brichon PY, Pison C, Chaffanjon P, Fayot P, Buchberger M, Neron L, Bocca A, Verdier J, Sarrazin R. Comparison of epidural analgesia and cryoanalgesia in thoracic surgery. Eur J Cardiothorac Surg. 1994;8(9):482-6. doi: 10.1016/1010-7940(94)90019-1.
PubMed 7811482Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19.
PubMed 23424242Tanaka A, Al-Rstum Z, Leonard SD, Gardiner BD, Yazij I, Sandhu HK, Miller CC 3rd, Safi HJ, Estrera AL. Intraoperative Intercostal Nerve Cryoanalgesia Improves Pain Control After Descending and Thoracoabdominal Aortic Aneurysm Repairs. Ann Thorac Surg. 2020 Jan;109(1):249-254. doi: 10.1016/j.athoracsur.2019.07.083. Epub 2019 Sep 12.
PubMed 31521592Clemence J Jr, Malik A, Farhat L, Wu X, Kim KM, Patel H, Yang B. Cryoablation of Intercostal Nerves Decreased Narcotic Usage After Thoracic or Thoracoabdominal Aortic Aneurysm Repair. Semin Thorac Cardiovasc Surg. 2020 Autumn;32(3):404-412. doi: 10.1053/j.semtcvs.2020.01.008. Epub 2020 Jan 20.
PubMed 31972300Bucerius J, Metz S, Walther T, Doll N, Falk V, Diegeler A, Autschbach R, Mohr FW. Pain is significantly reduced by cryoablation therapy in patients with lateral minithoracotomy. Ann Thorac Surg. 2000 Sep;70(3):1100-4. doi: 10.1016/s0003-4975(00)01766-5.
PubMed 11016387Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
PubMed 8080219Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
PubMed 3670870
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery
- ClinicalTrials.gov ID
- NCT05255146
- Acronym / sponsor ID
- Pro00113974
- Conditions
- Cryotherapy Effect, Post Operative Pain
- Keywords
- Minimally Invasive cardiac surgery, cryoanalgesia, mitral valve surgery, ASD repair, thoracotomy, pain management
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Logistical Issues; study never started up
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Study start
- Sep 2025 (estimated)
- Primary completion
- 4 May 2026 (actual)
- Study completion
- 4 May 2026 (actual)
- First posted
- 24 Feb 2022 (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.
Minimally invasive cardiothoracic surgery is often associated with chronic pain syndrome, out of keeping with the extent of surgical dissection. This is thought to be because of damage to the intercostal nerves by compression and traction by the surgical equipment. Cryoanalgesia is long-standing technique that freezes nerves locally to temporarily block pain sensation, which is currently used to treat acute post-operative pain in lung dissections and the Nuss procedure. We intend to perform a trial to assess whether using cryoanalgesia on intercostal nerves intraoperatively, reduces post-operative pain following minimally invasive cardiothoracic surgery.
Detailed description
Objective:
To characterize the effects of peri-operative intercostal cryoablation for the prevention of post thoracotomy pain following minimally invasive mitral valve surgery or atrial septal defect repair.
Rationale:
Minimally invasive cardiothoracic surgery is often associated with prolonged post-operative neuropathic pain not consistent with the acute pain experience of the initial surgery [1]. This is often thought to be secondary to an intercostal neuralgia caused by traction injuries to the intercostal neurovascular bundles by the surgical ports, a mini-thoracotomy, and mechanical retraction of the ribs.
Cryoanalgesia is an older but clinically relevant technique that causes local destruction of nerve axons using a nitrous oxide-cooled probe to -60°C [2]. This allows for temporary acute pain relief without damaging the endoneurium, allowing the peripheral nerves to regrow post-operatively. Previous studies have demonstrated cryoanalgesia as having improved acute post-operative pain vs opioids alone or similar acute pain management vs epidural analgesia [3,4]. A few studies have assessed Cryoanalgesia in thoracic surgery patients; however, these studies have focused primarily on lung operations involving pulmonary resections, and did not include cardiac operations [5,6]. Furthermore, studies that evaluated cardiothoracic operations specifically, were either retrospective or prospective in approach and did not include a representative variety of cardiac operations [7-9]. Therefore, we hope that by using intercostal cryoablation in minimally invasive cardiac surgery patients, we might improve post-operative pain and reduce analgesic requirements.
Sample Size and Statistical Considerations:
Analyses will be conducted on an intention-to-treat basis. Relative and absolute risk will be calculated with respect to the primary and secondary outcomes. We calculate a sample size of 50 patients per group in order to detect a reduction in incidence of post-thoracotomy pain from 50% to 20% (α=0.05, power=0.8). This includes an anticipated rate of non-completion of 15%.
Expected Results:
Based on our hypotheses and previous human RCT's, we expect intercostal cryoablation to improve post-thoracotomy pain when compared to controls. Furthermore, we expect an improvement in our secondary outcomes including sleep quality and analgesic requirements. Cryoanalgesia's efficacy in acute post-operative pain management is well documented in the neuropathic pain literature and has been used in a number of clinical trials. We hope that applying this concept to minimally invasive cardiothoracic procedures, we can see similar results in improved post-thoracotomy pain as reported by previous studies. We believe that, if successful, this project will offer an alternative and improved pain management regimen for patients undergoing minimally invasive thoracic surgery.
Significance:
The study proposed aims to provide new insight into the management of neuropathic pain associated with minimally invasive thoracic surgery. Pain -whether acute, chronic, nociceptive, or neuropathic- creates a significant burden to the patient, as well as to those around them. Our ultimate aim is to limit the overall pain experienced by patients. In doing this, we hope to influence a multitude of factors that affect patient welfare, including mood, patient safety, return to independence, return to work, etc. Many of these factors are often much more subjective and difficult to capture within the analytical framework of a clinical trial. However, it is our hope that by reducing pain, itself, we can continue to improve patient satisfaction and consequently, patient well-being.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a pilot, randomized, double-blinded, placebo-controlled trial evaluating the effect of intercostal cyroablation on the development of post-thoracotomy pain. With the use of computer-generated randomized blocks, patients will be assigned to either Cryoanalgesia or no-cryoanalgesia before undergoing surgery.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group: Cryoanalgesia | Experimental | Device: Atricure Inc. Nitrous oxide CryoprobePatients receiving cryoanalgesia peri-operatively during minimally invasive cardiothoracic surgery |
| Control Group: No Cyroanalgesia | No intervention | –Patients receiving minimally invasive cardiothoracic surgery who do not receive cryoanalgesia. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients aged 18 years or older scheduled for elective minimally invasive mitral valve surgery or atrial septal defect repair.
Key exclusion criteria (1 listed)
- Patients will be excluded if they are unable to fill in detailed health and pain related questionnaires, psychiatric disease preventing recall or accurate descriptions of pain, chronic pain syndromes, alcohol or illegal substance abuse, or pregnancy. Exclusion criteria also includes chronic use of opioids, allergy to morphine, bupivacaine, and/or ibuprofen, average pain during the last week >4 on a numerical rating scale from 0 to 10 with 0 indicating "no pain" and 10 indicating "the worst pain imaginable", contraindications to thoracic epidurals, prior chest surgery, or participation in another clinical trial.
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 |
|---|---|---|
| Atricure Inc. Nitrous oxide CryoprobeCryoanalgesia will be given by applying a nitrous oxide-cooled probe (AtriCure, Inc. 2000) locally to intercostal nerves in the 4th, 5th, and 6th rib spaces after completion of the surgical repair and before surgical closure. The probe will be cooled to -60°C and held on each location for 60 sec. | Device | Intervention Group: Cryoanalgesia |
Primary outcome
Post-operative Pain Day 1
Time frame: 1 day post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Post-operative Pain Day 3
Time frame: 3 days post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Post-operative Pain Day 5
Time frame: 5 days post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory, asked in-person by one of the researchers.
Long-term Post-operative Pain
Time frame: 6 weeks post-op
The incidence of significant post-thoracotomy pain will be assessed by the Brief Pain Inventory by asking the participants via phone call.
6 secondary outcomes
Sleep Quality
Time frame: 1 week post-op
Consumptions of Analgesics Day 1
Time frame: 1 day post-op
Consumptions of Analgesics Day 3
Time frame: 3 days post-op
Consumptions of Analgesics Day 5
Time frame: 5 Days post-op
Long-term Consumptions of Analgesics
Time frame: 6 weeks post-op
Length of Hospital Stay
Time frame: approximately 2 weeks post-op
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Background: PubMed 21075523Guastella V, Mick G, Soriano C, Vallet L, Escande G, Dubray C, Eschalier A. A prospective study of neuropathic pain induced by thoracotomy: incidence, clinical description, and diagnosis. Pain. 2011 Jan;152(1):74-81. doi: 10.1016/j.pain.2010.09.004. Epub 2010 Nov 13.
- Background: PubMed 2764595Muller LC, Salzer GM, Ransmayr G, Neiss A. Intraoperative cryoanalgesia for postthoracotomy pain relief. Ann Thorac Surg. 1989 Jul;48(1):15-8. doi: 10.1016/0003-4975(89)90169-0.
- Background: PubMed 17870625Ju H, Feng Y, Yang BX, Wang J. Comparison of epidural analgesia and intercostal nerve cryoanalgesia for post-thoracotomy pain control. Eur J Pain. 2008 Apr;12(3):378-84. doi: 10.1016/j.ejpain.2007.07.011. Epub 2007 Sep 17.
- Background: PubMed 34408872Park R, Coomber M, Gilron I, Shanthanna H. Cryoanalgesia for postsurgical pain relief in adults: A systematic review and meta-analysis. Ann Med Surg (Lond). 2021 Aug 5;69:102689. doi: 10.1016/j.amsu.2021.102689. eCollection 2021 Sep.
- Background: PubMed 7811482Brichon PY, Pison C, Chaffanjon P, Fayot P, Buchberger M, Neron L, Bocca A, Verdier J, Sarrazin R. Comparison of epidural analgesia and cryoanalgesia in thoracic surgery. Eur J Cardiothorac Surg. 1994;8(9):482-6. doi: 10.1016/1010-7940(94)90019-1.
- Background: PubMed 23424242Sepsas E, Misthos P, Anagnostopulu M, Toparlaki O, Voyagis G, Kakaris S. The role of intercostal cryoanalgesia in post-thoracotomy analgesia. Interact Cardiovasc Thorac Surg. 2013 Jun;16(6):814-8. doi: 10.1093/icvts/ivs516. Epub 2013 Feb 19.
- Background: PubMed 31521592Tanaka A, Al-Rstum Z, Leonard SD, Gardiner BD, Yazij I, Sandhu HK, Miller CC 3rd, Safi HJ, Estrera AL. Intraoperative Intercostal Nerve Cryoanalgesia Improves Pain Control After Descending and Thoracoabdominal Aortic Aneurysm Repairs. Ann Thorac Surg. 2020 Jan;109(1):249-254. doi: 10.1016/j.athoracsur.2019.07.083. Epub 2019 Sep 12.
- Background: PubMed 31972300Clemence J Jr, Malik A, Farhat L, Wu X, Kim KM, Patel H, Yang B. Cryoablation of Intercostal Nerves Decreased Narcotic Usage After Thoracic or Thoracoabdominal Aortic Aneurysm Repair. Semin Thorac Cardiovasc Surg. 2020 Autumn;32(3):404-412. doi: 10.1053/j.semtcvs.2020.01.008. Epub 2020 Jan 20.
- Background: PubMed 11016387Bucerius J, Metz S, Walther T, Doll N, Falk V, Diegeler A, Autschbach R, Mohr FW. Pain is significantly reduced by cryoablation therapy in patients with lateral minithoracotomy. Ann Thorac Surg. 2000 Sep;70(3):1100-4. doi: 10.1016/s0003-4975(00)01766-5.
- Background: PubMed 8080219Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
- Background: PubMed 3670870Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
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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.
Abeline R Watkins, BSc principal investigator
UofA Research/Department of Cardiac Surgery
Andrew O'Connell, MD principal investigator
UofA Department of Cardiac Surgery
Questions about this trial
What is this clinical trial studying?
A study testing Atricure Inc. Nitrous oxide Cryoprobe in people with Cryotherapy Effect and Post Operative Pain, run by University of Alberta.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative Pain Day 1 (time frame: 1 day post-op). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05255146, which also lists 11 linked publications.
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 8 May 2026.