Mitral RegurgitationBLOCKNCT06443931
Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery
A study testing cryoablation of intercostal nerves in people with Mitral Regurgitation and Pain, Postoperative, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Mitral Regurgitation, Pain, Postoperative
- What is being tested?
- cryoablation of intercostal nerves
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteRussia
- Study dates
- 10 Mar 2024to 31 Oct 2025
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent;
- Minimally invasive mitral valve surgery.
- Non-inclusion criteria:
- patient refusal;
- pregnancy;
- treatment with antidepressants or epileptic drugs;
Show all 9Show fewer
- depression, which can significantly affect the perception of pain;
- chronic use of analgesics;
- participation in competing randomized clinical trials.
Who cannot join
- Extended mechanical ventilation, more than 12 hours.
Trial locations and contacts
1 site in 1 country.
Russia1 site
Meshalkin Research Institute of Pathology of Circulation
Novosibirsk, 630055
About this study
Official title: Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery: a Pilot Prospective Randomized Study
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.
Read the detailed description
Cardiovascular diseases are one of the main causes of death worldwide. According to pathological studies, heart defects occur in 4-7% of cases, and the most common defect among the defects is damage to the mitral valve. Significant advances in surgical practice, instrumentation, tissue manipulation, and perfusion technology have made it possible to perform mitral valve surgery using mini-approaches. Minimally invasive mitral valve surgery has become the standard of care in some specialized cardiac centers around the world due to its excellent results, even despite longer cardiopulmonary bypass times and aortic occlusion. In 2008 a meta-analysis has been published in which the authors come to the conclusion that a minimally invasive approach for correcting mitral valve pathology actually has significant advantages: early activation of patients, shorter duration of stay in the recovery room, shorter wound healing times, advantages in case of repeated interventions, less the number of bleedings and purulent-septic complications compared to classical sternotomy. But despite all the advantages of this approach, severe pain after minimally invasive cardiac surgery continues to remain a serious problem. Acute pain occurs after dissection of the chest, pleura and pericardium, compression of the intercostal nerve with a retractor, as well as dissection of the intercostal and pectoral muscles during surgical access. It limits breathing and cough in the postoperative period, which can subsequently lead to hypoxemia, sputum stagnation, atelectasis, pneumonia, myocardial ischemia, slow recovery, and also an increase in the length of hospitalization. Therefore, additional emphasis and attention is paid to protocols for early functional restoration and pain reduction for this group of patients. There are protocols for "accelerated recovery after surgery" (ERAS - Enhanced Recovery After Surgery), their use makes it possible to achieve shorter stays in the intensive care unit, reduce hospitalization, improve treatment outcomes and reduce financial costs. One of the components of ERAS is the use of additional pain management modalities. However, in cardiac surgery, traditional methods of regional anesthesia, such as thoracic epidural anesthesia or paravertebral block, are not usually used due to intraoperative heparinization and the associated higher risk of spinal or epidural hematoma. Finding an optimal and effective pain management strategy for this category of patients remains an unsolved problem today.
Intercostal nerve cryoablation is considered a relatively new treatment for postoperative pain in patients undergoing minimally invasive mitral valve surgery. One of the first studies of cryoneurolysis was conducted back in 1974 in thoracic surgery. In 76 patients, the use of intercostal cryoablation resulted in a significant reduction in postoperative opioid analgesic consumption. These results were subsequently confirmed in several other studies and the data were retrospective. In 2000, a prospective randomized controlled trial was published involving 30 patients who underwent minimally invasive mitral valve surgery or minimally invasive coronary artery bypass grafting and underwent intercostal cryoablation. According to the results, a decrease in postoperative pain syndrome was observed, and less painkillers were required.
In the study in patients undergoing surgical stabilization of the ribs, cryoablation of the intercostal nerves resulted in a 25% reduction in opioid analgesics consumption compared with patients who received an extrapleural catheter, and pain scores were reduced by 22% in the cryoablation group. Similar results (cryoablation made it possible to significantly reduce morphine consumption compared to the control group and reduce pain)were also described inrecent retrospective studies through 2023 in other patient groups: patients who have undergone pulmonary resectionusing single-port thoracic video-assisted access, where cryoablation was used as a method of postoperative pain relief and patients undergoing lung transplantation.
In the other study for 2021 the use of this method in patients with lateral thoracotomy showed significant improvement in spirography parameters (FEV1, FVC) after 48 hours, as well as 30 and 60 days after surgery. Studying the influence of pain was not the main objective of this work; pain was assessed using VAS and did not show a difference. However, improvement in breathing parameters in the early postoperative period may indirectly be associated with a lower level of pain and a more comfortable state of the patient; the consumption of opioid analgesics was not properly assessed in this study.
In 2021 published a systematic review of 23 studies on the effectiveness of intercostal cryoneurolysis in patients with pectus excavatum, lateral thoracotomy, post-thoracotomy pain syndrome, traumatic rib fracture and chest wall malignancy. Most studies have demonstrated a reduction in inpatient opioid analgesic use with intercostal nerve cryoablation compared with traditional pain management techniques. In patients requiring lateral thoracotomy, intercostal cryoablation results in decreased opioid analgesic dosage (grade 2A) and improved pain scores (grade 2C) postoperatively (PICO guidelines).
Finding an effective and at the same time simple strategy for pain relief in the early postoperative period in patients undergoing minimally invasive mitral valve surgery is an urgent task; it is advisable to conduct a prospective clinical study with a well-thought-out design in this direction.
- Conditions
- Mitral Regurgitation, Pain, Postoperative
- Being tested
- cryoablation of intercostal nerves
- Keywords
- cryoablation, pain, minimally invasive mitral valve surgery
- Medical subject headings
- Mitral Valve Insufficiency, Pain, Postoperative, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryoablation of intercostal nervesProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid analgesic consumption
Opioid analgesics consumption after surgery, calculated in MME
Measured: 48 hours after surgery
Secondary outcomes (8)
The intensity of pain
We will use a visual analogue scale (VAS), that represent the severity of symptoms from 0 "no pain" to 10 "very severe pain".
Measured: After extubation, 6, 12, 24, 36, 48 hours after surgery
Dynamics of spirography (FEV1, FVC)
Measured: before surgery, 48 hours after surgery, before the patient's discharge
Frequency of side effects (nausea, vomiting, etc.)
Measured: 48 hours after surgery
Need for inotropic/vasopressor support
yes/no
Measured: during surgery and in the ICU
Duration of mechanical ventilation
number of hours
Measured: 12 hours
Duration of ICU stay
number of days
Measured: 10 days
Duration of hospital stay
number of days
Measured: 60 days
Identifying side effects of intercostal nerve cryoablation procedure (the occurrence of chronic post-thoracotomy pain syndrome, numbness in the right arm and in the area of surgical access)
follow-up
Measured: 2 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start10 Mar 2024
- Primary completion31 Oct 2025
- Study completion31 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Mitral RegurgitationStudies of the same condition, open and under way.
- 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
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Meshalkin Research Institute of Pathology of Circulation
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06443931
- Sponsor's protocol ID
- 01-4
- Acronym
- BLOCK
- Status last verified
- Dec 2025
- First submitted
- 30 May 2024
- Last updated
- 30 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 8893611Sherazee 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.
PubMed 35521910Lau 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 34545530O'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.
PubMed 37741705Maxwell 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.
PubMed 37461202Nelson 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.
PubMed 4413968Bucerius 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.
PubMed 11016387Koons 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.
PubMed 37063121Bolotin 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.
PubMed 11156086Mamoun 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.
PubMed 27236864
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery: a Pilot Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT06443931
- Acronym / sponsor ID
- BLOCK / 01-4
- Conditions
- Mitral Regurgitation, Pain, Postoperative
- Keywords
- cryoablation, pain, minimally invasive mitral valve surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Meshalkin Research Institute of Pathology of CirculationResearch network
- Study start
- 10 Mar 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 31 Oct 2025 (actual)
- First posted
- 5 Jun 2024 (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.
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.
Detailed description
Cardiovascular diseases are one of the main causes of death worldwide. According to pathological studies, heart defects occur in 4-7% of cases, and the most common defect among the defects is damage to the mitral valve. Significant advances in surgical practice, instrumentation, tissue manipulation, and perfusion technology have made it possible to perform mitral valve surgery using mini-approaches. Minimally invasive mitral valve surgery has become the standard of care in some specialized cardiac centers around the world due to its excellent results, even despite longer cardiopulmonary bypass times and aortic occlusion. In 2008 a meta-analysis has been published in which the authors come to the conclusion that a minimally invasive approach for correcting mitral valve pathology actually has significant advantages: early activation of patients, shorter duration of stay in the recovery room, shorter wound healing times, advantages in case of repeated interventions, less the number of bleedings and purulent-septic complications compared to classical sternotomy. But despite all the advantages of this approach, severe pain after minimally invasive cardiac surgery continues to remain a serious problem. Acute pain occurs after dissection of the chest, pleura and pericardium, compression of the intercostal nerve with a retractor, as well as dissection of the intercostal and pectoral muscles during surgical access. It limits breathing and cough in the postoperative period, which can subsequently lead to hypoxemia, sputum stagnation, atelectasis, pneumonia, myocardial ischemia, slow recovery, and also an increase in the length of hospitalization. Therefore, additional emphasis and attention is paid to protocols for early functional restoration and pain reduction for this group of patients. There are protocols for "accelerated recovery after surgery" (ERAS - Enhanced Recovery After Surgery), their use makes it possible to achieve shorter stays in the intensive care unit, reduce hospitalization, improve treatment outcomes and reduce financial costs. One of the components of ERAS is the use of additional pain management modalities. However, in cardiac surgery, traditional methods of regional anesthesia, such as thoracic epidural anesthesia or paravertebral block, are not usually used due to intraoperative heparinization and the associated higher risk of spinal or epidural hematoma. Finding an optimal and effective pain management strategy for this category of patients remains an unsolved problem today.
Intercostal nerve cryoablation is considered a relatively new treatment for postoperative pain in patients undergoing minimally invasive mitral valve surgery. One of the first studies of cryoneurolysis was conducted back in 1974 in thoracic surgery. In 76 patients, the use of intercostal cryoablation resulted in a significant reduction in postoperative opioid analgesic consumption. These results were subsequently confirmed in several other studies and the data were retrospective. In 2000, a prospective randomized controlled trial was published involving 30 patients who underwent minimally invasive mitral valve surgery or minimally invasive coronary artery bypass grafting and underwent intercostal cryoablation. According to the results, a decrease in postoperative pain syndrome was observed, and less painkillers were required.
In the study in patients undergoing surgical stabilization of the ribs, cryoablation of the intercostal nerves resulted in a 25% reduction in opioid analgesics consumption compared with patients who received an extrapleural catheter, and pain scores were reduced by 22% in the cryoablation group. Similar results (cryoablation made it possible to significantly reduce morphine consumption compared to the control group and reduce pain)were also described inrecent retrospective studies through 2023 in other patient groups: patients who have undergone pulmonary resectionusing single-port thoracic video-assisted access, where cryoablation was used as a method of postoperative pain relief and patients undergoing lung transplantation.
In the other study for 2021 the use of this method in patients with lateral thoracotomy showed significant improvement in spirography parameters (FEV1, FVC) after 48 hours, as well as 30 and 60 days after surgery. Studying the influence of pain was not the main objective of this work; pain was assessed using VAS and did not show a difference. However, improvement in breathing parameters in the early postoperative period may indirectly be associated with a lower level of pain and a more comfortable state of the patient; the consumption of opioid analgesics was not properly assessed in this study.
In 2021 published a systematic review of 23 studies on the effectiveness of intercostal cryoneurolysis in patients with pectus excavatum, lateral thoracotomy, post-thoracotomy pain syndrome, traumatic rib fracture and chest wall malignancy. Most studies have demonstrated a reduction in inpatient opioid analgesic use with intercostal nerve cryoablation compared with traditional pain management techniques. In patients requiring lateral thoracotomy, intercostal cryoablation results in decreased opioid analgesic dosage (grade 2A) and improved pain scores (grade 2C) postoperatively (PICO guidelines).
Finding an effective and at the same time simple strategy for pain relief in the early postoperative period in patients undergoing minimally invasive mitral valve surgery is an urgent task; it is advisable to conduct a prospective clinical study with a well-thought-out design in this direction.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cryoablation of intercostal nerves group | Experimental | Procedure: cryoablation of intercostal nervesPatients 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. |
| 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- Written informed consent;
- Minimally invasive mitral valve surgery.
- patient refusal;
- pregnancy;
- treatment with antidepressants or epileptic drugs;
Key exclusion criteria (1 listed)
- Extended mechanical ventilation, more than 12 hours.
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 |
|---|---|---|
| cryoablation of intercostal nervesPatients 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. | Procedure or surgery | Cryoablation of intercostal nerves group |
Primary outcome
Opioid analgesic consumption
Time frame: 48 hours after surgery
Opioid analgesics consumption after surgery, calculated in MME
8 secondary outcomes
The intensity of pain
Time frame: After extubation, 6, 12, 24, 36, 48 hours after surgery
Dynamics of spirography (FEV1, FVC)
Time frame: before surgery, 48 hours after surgery, before the patient's discharge
Frequency of side effects (nausea, vomiting, etc.)
Time frame: 48 hours after surgery
Need for inotropic/vasopressor support
Time frame: during surgery and in the ICU
Duration of mechanical ventilation
Time frame: 12 hours
Duration of ICU stay
Time frame: 10 days
Duration of hospital stay
Time frame: 60 days
Identifying side effects of intercostal nerve cryoablation procedure (the occurrence of chronic post-thoracotomy pain syndrome, numbness in the right arm and in the area of surgical access)
Time frame: 2 and 6 months
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 30 Dec 2025.
- Background: PubMed 8893611Navia 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.
- Background: PubMed 35521910Sherazee 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.
- 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 37741705O'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.
- Background: PubMed 37461202Maxwell 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.
- Background: PubMed 4413968Nelson 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.
- Background: PubMed 11016387Bucerius 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.
- Background: PubMed 37063121Koons 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.
- Background: PubMed 11156086Bolotin 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.
- Background: PubMed 27236864Mamoun 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.
- Bogachev-Prokofiev A. V. et al. Pathology of the mitral valve in connective tissue dysplasiaLink provided by the sponsor.
- Hoan D. T. et al. Continuous Unilateral Erector Spinae Plane Block versus Intravenous Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled TrialLink provided by the sponsor.
- 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 studyLink provided by the sponsor.
- Cha P. I. et al. Efficacy of intercostal cryoneurolysis as an analgesic adjunct for chest wall pain after surgery or trauma: systematic reviewLink provided by the sponsor.
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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 cryoablation of intercostal nerves in people with Mitral Regurgitation and Pain, Postoperative, run by Meshalkin Research Institute of Pathology of Circulation at 1 site in Russia.
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 9 inclusion and 1 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 30 Dec 2025. 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 Russia. 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?
Opioid analgesic consumption (time frame: 48 hours after surgery). 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 NCT06443931, which also lists 10 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 30 Dec 2025.