Back to resultsCryoanalgesia Study
Primary Purpose
Pain, Postoperative
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative
Eligibility Criteria
Inclusion Criteria: Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy Reasonable expectation to be extubated within 24 hours postop Exclusion Criteria: 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
Sites / Locations
- Northwestern UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cryoanalgesia
Standard of Care (Control)
Arm Description
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).
Patients in this arm will receive standard of care pain management alone.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Quality of Recovery Score
Scale Title: Quality of Recovery Score Scale Values: 0 - 18 Higher score means a better outcome.
Patient Satisfaction with Pain Control Regimen
Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.
Pain Quality
Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.
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.
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.
Pain Severity
Scale Title: Numeric Pain Rating Scale Scale Values: 0-10 Higher score means a worse outcome.
Average Daily Pain Scores
Scale Title: CPOT (Critical-Care Pain Observation Tool) Scale Values: 0-8 Higher score means a worse outcome.
Average Daily Pain Scores
Scale Title: NRS (Numeric Rating Scale) Scale Values: 0-10 Higher score means a worse outcome.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05859061
Brief Title
Cryoanalgesia Study
Official Title
Intraoperative Cryoanalgesia for Pain Management After Sternotomy: A Randomized Pilot Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 10, 2023 (Actual)
Primary Completion Date
April 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
32 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cryoanalgesia
Arm Type
Experimental
Arm Description
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).
Arm Title
Standard of Care (Control)
Arm Type
No Intervention
Arm Description
Patients in this arm will receive standard of care pain management alone.
Intervention Type
Device
Intervention Name(s)
cryoICE® system (AtriCure, Inc) with CryoSphere (CryoS) probe
Other Intervention Name(s)
Cryoablation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Average Daily Opioid Consumption in MME
Description
The average daily opioid consumption in morphine milligram equivalents (MME) during the first 48 hours postoperatively serves as the study's primary outcome.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Quality of Recovery Score
Description
Scale Title: Quality of Recovery Score Scale Values: 0 - 18 Higher score means a better outcome.
Time Frame
48 hours/POD2 (post-operative day 2), 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Title
Patient Satisfaction with Pain Control Regimen
Description
Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.
Time Frame
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Title
Pain Quality
Description
Scale Title: IPO (International Pain Outcomes) Questionnaire Scale Values: 0 - 320 Higher score means a worse outcome.
Time Frame
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Title
Pain Quality
Description
Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome.
Time Frame
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Title
Pain Severity
Description
Scale Title: S-LANSS (Leeds Assessment of Neuropathic Symptoms and Signs) Pain Score Scale Values: 0-24 Higher score means a worse outcome.
Time Frame
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Title
Pain Severity
Description
Scale Title: Numeric Pain Rating Scale Scale Values: 0-10 Higher score means a worse outcome.
Time Frame
24 hours/POD1 (post-operative day 1), 48 hours/POD2, 10 days +/- 4 days, 90 days +/- 14 days, & 180 days +/- 30 days
Title
Average Daily Pain Scores
Description
Scale Title: CPOT (Critical-Care Pain Observation Tool) Scale Values: 0-8 Higher score means a worse outcome.
Time Frame
during the first 48 hours postoperatively (starting upon ICU arrival)
Title
Average Daily Pain Scores
Description
Scale Title: NRS (Numeric Rating Scale) Scale Values: 0-10 Higher score means a worse outcome.
Time Frame
during the first 48 hours postoperatively (starting upon ICU arrival)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Scheduled for elective CABG (coronary artery bypass graft) or single valve surgery via median sternotomy
Reasonable expectation to be extubated within 24 hours postop
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nora Ibrahim
Phone
3126955152
Email
nora.ibrahim@northwestern.edu
Facility Information:
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nora Ibrahim, BA
Phone
312-695-5152
Email
nora.ibrahim@northwestern.edu
First Name & Middle Initial & Last Name & Degree
Anirban Sahu, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27343790
Citation
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.
Results Reference
background
PubMed Identifier
21955825
Citation
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.
Results Reference
background
PubMed Identifier
30333328
Citation
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.
Results Reference
background
PubMed Identifier
30861264
Citation
Raj N. Regional anesthesia for sternotomy and bypass-Beyond the epidural. Paediatr Anaesth. 2019 May;29(5):519-529. doi: 10.1111/pan.13626.
Results Reference
background
PubMed Identifier
32275036
Citation
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.
Results Reference
background
PubMed Identifier
33133875
Citation
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.
Results Reference
background
PubMed Identifier
16880882
Citation
Trescot AM. Cryoanalgesia in interventional pain management. Pain Physician. 2003 Jul;6(3):345-60.
Results Reference
background
PubMed Identifier
6102235
Citation
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.
Results Reference
background
PubMed Identifier
30935731
Citation
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.
Results Reference
background
PubMed Identifier
34408872
Citation
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.
Results Reference
background
PubMed Identifier
34545530
Citation
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.
Results Reference
background
PubMed Identifier
28800982
Citation
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.
Results Reference
background
PubMed Identifier
30197534
Citation
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.
Results Reference
background
PubMed Identifier
15772908
Citation
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.
Results Reference
background
PubMed Identifier
24021577
Citation
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.
Results Reference
background
PubMed Identifier
33593526
Citation
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.
Results Reference
background
PubMed Identifier
34352198
Citation
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.
Results Reference
background
PubMed Identifier
31903564
Citation
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.
Results Reference
background
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Cryoanalgesia Study
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