Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery

NCT06443931 | Completed

• 1 other identifier: 01-4
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, pilot, prospective, randomized clinical trial with a 1:1 allocation ratio. The aim of our trial is to determine whether cryoablation of intercostal nerves provides a clinically significant analgesic effect, which is reflected in a decrease in opioid analgesics consumption and in a decrease in pain according to VAS in patients undergoing minimally invasive mitral valve surgery. To obtain preliminary data for planning a subsequent larger prospective randomized trial.

Conditions

Mitral Regurgitation; Pain, Postoperative

Keywords

cryoablation; pain; minimally invasive mitral valve surgery

Outcome Measures

Primary Outcomes (1)

• Opioid analgesic consumption

  Opioid analgesics consumption after surgery, calculated in MME

  48 hours after surgery

Secondary Outcomes (8)

• The intensity of pain

  After extubation, 6, 12, 24, 36, 48 hours after surgery

• Dynamics of spirography (FEV1, FVC)

  before surgery, 48 hours after surgery, before the patient's discharge

• Frequency of side effects (nausea, vomiting, etc.)

  48 hours after surgery

• Need for inotropic/vasopressor support

  during surgery and in the ICU

• Duration of mechanical ventilation

  12 hours

Study Arms (2)

Cryoablation of intercostal nerves group

EXPERIMENTAL

Patients in the CryoINB group will undergo cryoablation of the intercostal nerves, at the end of surgery before weaning from CPB, using the "ArtiCue" device for 120 seconds at a temperature of -50°C to -70°C, in the intercostal spaces where the surgical approach is located, one intercostal space above and one below it.

Procedure: cryoablation of intercostal nerves

Standard pain management protocol group

NO INTERVENTION

Patients in the group with the standard anesthesia protocol will receive an intercostal block in the area of surgical access - a single injection of 0.75% ropivacaine solution 20 ml.

Interventions

cryoablation of intercostal nerves PROCEDURE

Patients in the CryoINB group will undergo cryoablation of the intercostal nerves, at the end of surgery before weaning from CPB, using the "ArtiCue" device for 120 seconds at a temperature of -50°C to -70°C, in the intercostal spaces where the surgical approach is located, one intercostal space above and one below it. Cold leads to axonotmesis, in which the axon and myelin sheath are damaged, preventing the pain signal from traveling along the sensory nerve. However, the structural elements of the nerve are preserved, which promotes complete regeneration at a rate of 1-2 mm per day, thereby restoring normal function within several months.

Cryoablation of intercostal nerves group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent;
• Minimally invasive mitral valve surgery.
• patient refusal;
• pregnancy;
• treatment with antidepressants or epileptic drugs;
• depression, which can significantly affect the perception of pain;
• chronic use of analgesics;
• participation in competing randomized clinical trials.

You may not qualify if:

• \- Extended mechanical ventilation, more than 12 hours.

Sponsors & Collaborators

• Meshalkin Research Institute of Pathology of Circulation: lead

Study Sites (1)

Meshalkin Research Institute of Pathology of Circulation

Novosibirsk, 630055, Russia

Location

Related Publications (10)

• Navia JL, Cosgrove DM 3rd. Minimally invasive mitral valve operations. Ann Thorac Surg. 1996 Nov;62(5):1542-4. doi: 10.1016/0003-4975(96)00779-5.

  PMID: 8893611 BACKGROUND

• Sherazee EA, Chen SA, Li D, Li D, Frank P, Kiaii B. Pain Management Strategies for Minimally Invasive Cardiothoracic Surgery. Innovations (Phila). 2022 May-Jun;17(3):167-176. doi: 10.1177/15569845221091779. Epub 2022 May 6. No abstract available.

  PMID: 35521910 BACKGROUND

• 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: 34545530 BACKGROUND

• O'Connor LA, Houseman B, Cook T, Quinn CC. Intercostal cryonerve block versus elastomeric infusion pump for postoperative analgesia following surgical stabilization of traumatic rib fractures. Injury. 2023 Nov;54(11):111053. doi: 10.1016/j.injury.2023.111053. Epub 2023 Sep 18.

  PMID: 37741705 BACKGROUND

• Maxwell CM, Weksler B, Houda J, Fernando HC. Intercostal Cryoablation During Video-Assisted Lung Resection Can Decrease Postoperative Opioid Use. Innovations (Phila). 2023 Jul-Aug;18(4):352-356. doi: 10.1177/15569845231185583. Epub 2023 Jul 17.

  PMID: 37461202 BACKGROUND

• Nelson KM, Vincent RG, Bourke RS, Smith DE, Blakeley WR, Kaplan RJ, Pollay M. Intraoperative intercostal nerve freezing to prevent postthoracotomy pain. Ann Thorac Surg. 1974 Sep;18(3):280-5. doi: 10.1016/s0003-4975(10)64357-3. No abstract available.

  PMID: 4413968 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

• Koons B, Suzuki Y, Cevasco M, Bermudez CA, Harmon MT, Dallara L, Ramon CV, Nottingham A, Ganjoo N, Diamond JM, Christie JD, Localio AR, Cantu E. Cryoablation in lung transplantation: Its impact on pain, opioid use, and outcomes. JTCVS Open. 2022 Nov 25;13:444-456. doi: 10.1016/j.xjon.2022.11.005. eCollection 2023 Mar.

  PMID: 37063121 BACKGROUND

• Bolotin G, Lazarovici H, Uretzky G, Zlotnick AY, Tamir A, Saute M. The efficacy of intraoperative internal intercostal nerve block during video-assisted thoracic surgery on postoperative pain. Ann Thorac Surg. 2000 Dec;70(6):1872-5. doi: 10.1016/s0003-4975(00)01757-4.

  PMID: 11156086 BACKGROUND

• Mamoun NF, Lin P, Zimmerman NM, Mascha EJ, Mick SL, Insler SR, Sessler DI, Duncan AE. Intravenous acetaminophen analgesia after cardiac surgery: A randomized, blinded, controlled superiority trial. J Thorac Cardiovasc Surg. 2016 Sep;152(3):881-889.e1. doi: 10.1016/j.jtcvs.2016.04.078. Epub 2016 May 5.

  PMID: 27236864 BACKGROUND

Related Links

• Bogachev-Prokofiev A. V. et al. Pathology of the mitral valve in connective tissue dysplasia
• Hoan D. T. et al. Continuous Unilateral Erector Spinae Plane Block versus Intravenous Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial
• Borys M. et al. Erector spinae-plane block as an analgesic alternative in patients undergoing mitral and/or tricuspid valve repair through a right mini-thoracotomy-an observational cohort study
• Cha P. I. et al. Efficacy of intercostal cryoneurolysis as an analgesic adjunct for chest wall pain after surgery or trauma: systematic review

MeSH Terms

Conditions

Mitral Valve Insufficiency; Pain, Postoperative; Pain

Condition Hierarchy (Ancestors)

Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: Patients undergoing minimally invasive mitral valve surgery while on cardiopulmonary bypass will be randomized into two groups: 1. Patients receiving cryoablation of intercostal nerves (CryoINB) as a method of pain relief. 2. Patients who will undergo a standard pain management protocol.

Study Record Dates

• First Submitted: May 30, 2024
• First Posted: June 5, 2024
• Study Start: March 10, 2024
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: December 30, 2025

Record last verified: 2025-12

Locations

RU (1)