Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06443931
Status:
RECRUITING
Last Update Posted:
2024-06-05
First Post:
2024-05-30
Brief Title:
Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Organization:
Meshalkin Research Institute of Pathology of Circulation
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
BLOCK
Brief Summary:
A single-center pilot prospective randomized clinical trial with a 11 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 1 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 P Modi and co-authors 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 2 But despite all the advantages of this approach severe pain after minimally invasive cardiac surgery continues to remain a serious problem 3 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 4 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 5 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 9 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 10
In the study OConnor LA et al 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 7 Similar results cryoablation made it possible to significantly reduce morphine consumption compared to the control group and reduce painwere 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 8 and patients undergoing lung transplantation 12
In the FROST 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 6 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 2021Peter I Cha and others 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 11
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
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 9 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 10
In the study OConnor LA et al 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 7 Similar results cryoablation made it possible to significantly reduce morphine consumption compared to the control group and reduce painwere 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 8 and patients undergoing lung transplantation 12
In the FROST 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 6 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 2021Peter I Cha and others 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 11
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None