Cryoanalgesia and Post-thoracotomy Pain in Minimally Invasive Cardiothoracic Surgery

NCT05255146 | Not Yet Recruiting

• 1 other identifier: Pro00113974
• Study Type: interventional
• Target: 100
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

Cryotherapy Effect; Post Operative Pain

Keywords

Minimally Invasive cardiac surgery; cryoanalgesia; mitral valve surgery; ASD repair; thoracotomy; pain management

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  6 weeks post-op

Secondary Outcomes (6)

• Sleep Quality

  1 week post-op

• Consumptions of Analgesics Day 1

  1 day post-op

• Consumptions of Analgesics Day 3

  3 days post-op

• Consumptions of Analgesics Day 5

  5 Days post-op

• Long-term Consumptions of Analgesics

  6 weeks post-op

Study Arms (2)

Intervention Group: Cryoanalgesia

EXPERIMENTAL

Patients receiving cryoanalgesia peri-operatively during minimally invasive cardiothoracic surgery

Device: Atricure Inc. Nitrous oxide Cryoprobe

Control Group: No Cyroanalgesia

NO INTERVENTION

Patients receiving minimally invasive cardiothoracic surgery who do not receive cryoanalgesia.

Interventions

Atricure Inc. Nitrous oxide Cryoprobe DEVICE

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.

Intervention Group: Cryoanalgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients aged 18 years or older scheduled for elective minimally invasive mitral valve surgery or atrial septal defect repair.

Sponsors & Collaborators

• University of Alberta: lead

Related Publications (11)

• 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.

  PMID: 21075523 BACKGROUND

• Muller 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.

  PMID: 2764595 BACKGROUND

• Ju 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.

  PMID: 17870625 BACKGROUND

• 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: 34408872 BACKGROUND

• Brichon 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.

  PMID: 7811482 BACKGROUND

• Sepsas 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.

  PMID: 23424242 BACKGROUND

• Tanaka 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.

  PMID: 31521592 BACKGROUND

• Clemence 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.

  PMID: 31972300 BACKGROUND

• Bucerius 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.

  PMID: 11016387 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

  PMID: 3670870 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Abeline R Watkins, BSc

  UofA Research/Department of Cardiac Surgery

  PRINCIPAL INVESTIGATOR

• Andrew O'Connell, MD

  UofA Department of Cardiac Surgery

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeevan Nagendran, MD, PhD

CONTACT

(780) 492-7605; jeevan@ualberta.ca

Micheal Moon, MD, PhD

CONTACT

780-407-6861; mmoon@ualberta.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Patients will be randomized to either study group before surgery without the patient's knowledge of which group they are in. The surgeons (care providers) will need to be aware of the intervention so that they can supply the cryoanalgesia or not peri-operatively. The investigator and data analyst will also be blind to the intervention type when collecting patient outcome information and doing statistical analysis. Randomization will be documented in secure password protected databases that only the surgeons will have access too, matching patient identifiers to intervention groups for reference for final data presentation.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2022
• First Posted: February 24, 2022
• Study Start: September 1, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 25, 2025

Record last verified: 2025-03