NCT05859061

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 10, 2023

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

April 13, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2024

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
Last Updated

June 18, 2025

Status Verified

June 1, 2025

Enrollment Period

1.3 years

First QC Date

April 13, 2023

Last Update Submit

June 13, 2025

Conditions

Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

  • 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.

    48 hours

Secondary Outcomes (8)

  • Quality of Recovery Score

    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

    24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

  • Pain Quality

    24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

  • Pain Quality

    24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

  • Pain Severity

    24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days

  • +3 more secondary outcomes

Study Arms (2)

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).

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.

Interventions

cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probeDEVICE

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.

Also known as: Cryoablation
Cryoanalgesia

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
  • Reasonable expectation to be extubated within 24 hours postop

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University

Chicago, Illinois, 60611, United States

Location

Related Publications (18)

  • 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.

    PMID: 27343790BACKGROUND

  • Mazzeffi 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.

    PMID: 21955825BACKGROUND

  • Nachiyunde 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.

    PMID: 30333328BACKGROUND

  • Raj N. Regional anesthesia for sternotomy and bypass-Beyond the epidural. Paediatr Anaesth. 2019 May;29(5):519-529. doi: 10.1111/pan.13626.

    PMID: 30861264BACKGROUND

  • Kar 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.

    PMID: 32275036BACKGROUND

  • Pala 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.

    PMID: 33133875BACKGROUND

  • Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.

    PMID: 16880882BACKGROUND

  • Katz 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.

    PMID: 6102235BACKGROUND

  • Graves 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.

    PMID: 30935731BACKGROUND

  • Park 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.

    PMID: 34408872BACKGROUND

  • Lau 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.

    PMID: 34545530BACKGROUND

  • Rijkenberg 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.

    PMID: 28800982BACKGROUND

  • Zubrzycki 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.

    PMID: 30197534BACKGROUND

  • Bennett 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.

    PMID: 15772908BACKGROUND

  • Rothaug 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.

    PMID: 24021577BACKGROUND

  • Bauman ZM, Loftus J, Raposo-Hadley A, Samuel S, Ernst W, Evans CH, Cemaj S, Kaye AJ. Surgical stabilization of rib fractures combined with intercostal nerve cryoablation proves to be more cost effective by reducing hospital length of stay and narcotics. Injury. 2021 May;52(5):1128-1132. doi: 10.1016/j.injury.2021.02.009. Epub 2021 Feb 6.

    PMID: 33593526BACKGROUND

  • Salenger R, Holmes SD, Rea A, Yeh J, Knott K, Born R, Boss MJ, Barr LF. Cardiac Enhanced Recovery After Surgery: Early Outcomes in a Community Setting. Ann Thorac Surg. 2022 Jun;113(6):2008-2017. doi: 10.1016/j.athoracsur.2021.06.072. Epub 2021 Aug 2.

    PMID: 34352198BACKGROUND

  • Myles PS. More than just morbidity and mortality - quality of recovery and long-term functional recovery after surgery. Anaesthesia. 2020 Jan;75 Suppl 1:e143-e150. doi: 10.1111/anae.14786.

    PMID: 31903564BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of Anesthesiology

Study Record Dates

First Submitted

April 13, 2023

First Posted

May 15, 2023

Study Start

April 10, 2023

Primary Completion

July 20, 2024

Study Completion

February 13, 2025

Last Updated

June 18, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)