Pain, PostoperativeNCT05859061
Cryoanalgesia Study
A study testing cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe in people with Pain, Postoperative, run by Northwestern University at 1 site in United States.
Trial summary
This study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. Cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative
- What is being tested?
- cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Apr 2023to 20 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
- Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
- Reasonable expectation to be extubated within 24 hours postop
Who cannot join
- Prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy)
- Hemisternotomy approach
- History of cold urticaria, cryoglobulinemia, Raynaud's disease, or diabetic neuropathy
- Preoperative use of opioids
- History of chronic pain or associated syndromes
- Concurrent Cox maze procedure
Show all 9Show fewer
- Need for post-bypass mechanical circulatory support (ECMO, IABP) or open chest
- Women who are pregnant or breastfeeding
- Patients who are unable to consent for themselves
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial
This study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. Cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. Cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores, and shorter hospital stays. The results of this study may lead to a useful alternative for pain control in cardiac surgery patients.
- Conditions
- Pain, Postoperative
- Being tested
- cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probeDevice
Also called Cryoablation
Per manufacturer instructions, the cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. The study team plans to perform each cryoablation (-50°C to -70°C) for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). The probe will be removed after defrosting to avoid mechanical damage to the intercostal nerve. Cryoablation will be performed once hemostasis is achieved and prior to sternal wire placement and chest closure by a provider from the cardiac surgery team.
| Study group | Role | What they receive |
|---|---|---|
| Cryoanalgesia | Experimental | Intraoperative analgesic administration will be at the discretion of the anesthesia provider. Once adequate hemostasis is achieved and prior to sternal wire placement and chest closure, patients will undergo cryoablation of bilateral T2 - T6 intercostal nerves. The cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. Each cryoablation at -50°C to -70°C will be applied for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). Receives: Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe |
| Standard of Care (Control) | No intervention | Patients in this arm will receive standard of care pain management alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Daily Opioid Consumption in MME
The average daily opioid consumption in morphine milligram equivalents (MME) during the first 48 hours postoperatively serves as the study's primary outcome.
Measured: 48 hours
Secondary outcomes (8)
Quality of Recovery Score
Scale Title: Quality of Recovery Score Scale Values: 0 - 18 Higher score means a better outcome.
Measured: 48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Patient Satisfaction with Pain Control Regimen
Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.
Measured: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Quality
Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.
Measured: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Quality
Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome.
Measured: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Severity
Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome.
Measured: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Severity
Scale Title: Numeric Pain Rating Scale Scale Values: 0-10 Higher score means a worse outcome.
Measured: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Average Daily Pain Scores
Scale Title: CPOT (Critical-Care Pain Observation Tool) Scale Values: 0-8 Higher score means a worse outcome.
Measured: during the first 48 hours postoperatively (starting upon ICU arrival)
Average Daily Pain Scores
Scale Title: NRS (Numeric Rating Scale) Scale Values: 0-10 Higher score means a worse outcome.
Measured: during the first 48 hours postoperatively (starting upon ICU arrival)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2023
- Study start10 Apr 2023
- Primary completion20 May 2026
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05859061
- Sponsor's protocol ID
- STU00218457
- Status last verified
- Jul 2026
- First submitted
- 13 Apr 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.
PubMed 27343790Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
PubMed 21955825Nachiyunde B, Lam L. The efficacy of different modes of analgesia in postoperative pain management and early mobilization in postoperative cardiac surgical patients: A systematic review. Ann Card Anaesth. 2018 Oct-Dec;21(4):363-370. doi: 10.4103/aca.ACA_186_17.
PubMed 30333328Raj N. Regional anesthesia for sternotomy and bypass-Beyond the epidural. Paediatr Anaesth. 2019 May;29(5):519-529. doi: 10.1111/pan.13626.
PubMed 30861264Kar P, Ramachandran G. Pain relief following sternotomy in conventional cardiac surgery: A review of non neuraxial regional nerve blocks. Ann Card Anaesth. 2020 Apr-Jun;23(2):200-208. doi: 10.4103/aca.ACA_241_18.
PubMed 32275036Pala AA, Urcun YS, Cicek OF, Sahin S. Can Continuous Local Anesthetic Infusion After Median Sternotomy Reduce Opioid Use? Cureus. 2020 Sep 29;12(9):e10711. doi: 10.7759/cureus.10711.
PubMed 33133875Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
PubMed 16880882Katz J, Nelson W, Forest R, Bruce DL. Cryoanalgesia for post-thoracotomy pain. Lancet. 1980 Mar 8;1(8167):512-3. doi: 10.1016/s0140-6736(80)92766-x.
PubMed 6102235Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 17.
PubMed 30935731Park 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 34408872Lau WC, Shannon FL, Bolling SF, Romano MA, Sakwa MP, Trescot A, Shi L, Johnson RL, Starnes VA, Grehan JF. Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial. Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20.
PubMed 34545530Rijkenberg S, Stilma W, Bosman RJ, van der Meer NJ, van der Voort PHJ. Pain Measurement in Mechanically Ventilated Patients After Cardiac Surgery: Comparison of the Behavioral Pain Scale (BPS) and the Critical-Care Pain Observation Tool (CPOT). J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1227-1234. doi: 10.1053/j.jvca.2017.03.013. Epub 2017 Mar 15.
PubMed 28800982Zubrzycki M, Liebold A, Skrabal C, Reinelt H, Ziegler M, Perdas E, Zubrzycka M. Assessment and pathophysiology of pain in cardiac surgery. J Pain Res. 2018 Aug 24;11:1599-1611. doi: 10.2147/JPR.S162067. eCollection 2018.
PubMed 30197534Bennett MI, Smith BH, Torrance N, Potter J. The S-LANSS score for identifying pain of predominantly neuropathic origin: validation for use in clinical and postal research. J Pain. 2005 Mar;6(3):149-58. doi: 10.1016/j.jpain.2004.11.007.
PubMed 15772908Rothaug J, Zaslansky R, Schwenkglenks M, Komann M, Allvin R, Backstrom R, Brill S, Buchholz I, Engel C, Fletcher D, Fodor L, Funk P, Gerbershagen HJ, Gordon DB, Konrad C, Kopf A, Leykin Y, Pogatzki-Zahn E, Puig M, Rawal N, Taylor RS, Ullrich K, Volk T, Yahiaoui-Doktor M, Meissner W. Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire. J Pain. 2013 Nov;14(11):1361-70. doi: 10.1016/j.jpain.2013.05.016. Epub 2013 Sep 7.
PubMed 24021577
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT05859061
- Acronym / sponsor ID
- STU00218457
- Conditions
- Pain, Postoperative
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 10 Apr 2023 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 15 May 2023 (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.
This study will investigate the feasibility of cryoanalgesia in patients undergoing cardiac surgery via a median sternotomy. Cryoanalgesia is a technique that uses extremely cold temperatures to temporarily ablate nerves and block pain signals. Cryoanalgesia has been used for decades for pain control after thoracic surgery and has been associated with decreased opioid consumption, decreased pain scores, and shorter hospital stays. The results of this study may lead to a useful alternative for pain control in cardiac surgery patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cryoanalgesia | Experimental | Device: cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probeIntraoperative analgesic administration will be at the discretion of the anesthesia provider. Once adequate hemostasis is achieved and prior to sternal wire placement and chest closure, patients will undergo cryoablation of bilateral T2 - T6 intercostal nerves. The cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. Each cryoablation at -50°C to -70°C will be applied for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). |
| Standard of Care (Control) | No intervention | –Patients in this arm will receive standard of care pain management alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
- Reasonable expectation to be extubated within 24 hours postop
Key exclusion criteria (9 listed)
- Prior history of surgery to the thorax (sternotomy, thoracotomy, thoracoscopy)
- Hemisternotomy approach
- History of cold urticaria, cryoglobulinemia, Raynaud's disease, or diabetic neuropathy
- Preoperative use of opioids
- History of chronic pain or associated syndromes
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 |
|---|---|---|
| cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probeAlso: CryoablationPer manufacturer instructions, the cryoprobe will be positioned under direct visualization and ablation of the intercostal nerve will be performed 2-4 cm lateral to the internal mammary artery near the mid-clavicular line. The study team plans to perform each cryoablation (-50°C to -70°C) for 120 seconds to sustain an ablation length of 2-3 cm at each intercostal nerve (bilateral T2 - T6). The probe will be removed after defrosting to avoid mechanical damage to the intercostal nerve. Cryoablation will be performed once hemostasis is achieved and prior to sternal wire placement and chest closure by a provider from the cardiac surgery team. | Device | Cryoanalgesia |
Primary outcome
Average Daily Opioid Consumption in MME
Time frame: 48 hours
The average daily opioid consumption in morphine milligram equivalents (MME) during the first 48 hours postoperatively serves as the study's primary outcome.
8 secondary outcomes
Quality of Recovery Score
Time frame: 48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Patient Satisfaction with Pain Control Regimen
Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Quality
Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Quality
Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Severity
Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Pain Severity
Time frame: 24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Average Daily Pain Scores
Time frame: during the first 48 hours postoperatively (starting upon ICU arrival)
Average Daily Pain Scores
Time frame: during the first 48 hours postoperatively (starting upon ICU arrival)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Background: PubMed 27343790Huang AP, Sakata RK. Pain after sternotomy - review. Braz J Anesthesiol. 2016 Jul-Aug;66(4):395-401. doi: 10.1016/j.bjane.2014.09.013. Epub 2016 Apr 23.
- Background: PubMed 21955825Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
- Background: PubMed 30333328Nachiyunde B, Lam L. The efficacy of different modes of analgesia in postoperative pain management and early mobilization in postoperative cardiac surgical patients: A systematic review. Ann Card Anaesth. 2018 Oct-Dec;21(4):363-370. doi: 10.4103/aca.ACA_186_17.
- Background: PubMed 30861264Raj N. Regional anesthesia for sternotomy and bypass-Beyond the epidural. Paediatr Anaesth. 2019 May;29(5):519-529. doi: 10.1111/pan.13626.
- Background: PubMed 32275036Kar P, Ramachandran G. Pain relief following sternotomy in conventional cardiac surgery: A review of non neuraxial regional nerve blocks. Ann Card Anaesth. 2020 Apr-Jun;23(2):200-208. doi: 10.4103/aca.ACA_241_18.
- Background: PubMed 33133875Pala AA, Urcun YS, Cicek OF, Sahin S. Can Continuous Local Anesthetic Infusion After Median Sternotomy Reduce Opioid Use? Cureus. 2020 Sep 29;12(9):e10711. doi: 10.7759/cureus.10711.
- Background: PubMed 16880882Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
- Background: PubMed 6102235Katz J, Nelson W, Forest R, Bruce DL. Cryoanalgesia for post-thoracotomy pain. Lancet. 1980 Mar 8;1(8167):512-3. doi: 10.1016/s0140-6736(80)92766-x.
- Background: PubMed 30935731Graves CE, Moyer J, Zobel MJ, Mora R, Smith D, O'Day M, Padilla BE. Intraoperative intercostal nerve cryoablation During the Nuss procedure reduces length of stay and opioid requirement: A randomized clinical trial. J Pediatr Surg. 2019 Nov;54(11):2250-2256. doi: 10.1016/j.jpedsurg.2019.02.057. Epub 2019 Mar 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 34545530Lau WC, Shannon FL, Bolling SF, Romano MA, Sakwa MP, Trescot A, Shi L, Johnson RL, Starnes VA, Grehan JF. Intercostal Cryo Nerve Block in Minimally Invasive Cardiac Surgery: The Prospective Randomized FROST Trial. Pain Ther. 2021 Dec;10(2):1579-1592. doi: 10.1007/s40122-021-00318-0. Epub 2021 Sep 20.
- Background: PubMed 28800982Rijkenberg S, Stilma W, Bosman RJ, van der Meer NJ, van der Voort PHJ. Pain Measurement in Mechanically Ventilated Patients After Cardiac Surgery: Comparison of the Behavioral Pain Scale (BPS) and the Critical-Care Pain Observation Tool (CPOT). J Cardiothorac Vasc Anesth. 2017 Aug;31(4):1227-1234. doi: 10.1053/j.jvca.2017.03.013. Epub 2017 Mar 15.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe in people with Pain, Postoperative, run by Northwestern University 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 2 inclusion and 9 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: finished, as of the sponsor's last update on 27 Jul 2026. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Average Daily Opioid Consumption in MME (time frame: 48 hours). 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 NCT05859061, which also lists 18 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 27 Jul 2026.