- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06086535
Intercostal Nerve Cryoanalgesia vs BRILMA Block for Minithoracotomy on Cardiac Surgery
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Patients undegoing cardiac surgery by minithoracotomy present severe acute postoperative pain. Cryoanalgesia of the intercostal nerves and BRILMA block are performed as techniques of postoperative analgesia of the chest wall, and can provide a solution for this postoperative pain. Both nerve block techniques could have similar effects on postoperative pain control during the first postoperative hours. However, cryoanalgesia of the intercostal nerves may provide a longer duration than that provided by BRILMA block.
Outcomes:
- Compare the postoperative analgesia provided by BRILMA block and intercostal nerve cryoanalgesia in patients undergoing cardiac surgery by minithoracotomy.
- Determine the percentage of patients with neuropathic pain at hospital discharge and 30 days after surgery.
Methods:
Prospective observational study using two analgesic techniques (BRILMA block vs intercostal nerve cryoanalgesia).
Inclusion criteria: patients > 18 years of age, underwent cardiac surgery by minithoracotomy Exclusion criteria: patients <18 years old, patients undergoing cardiac surgery by sternotomy, habitual consumption of analgesics, neurological diseases with deterioration of the level of consciousness and patients with previous neuropathic pain.
Technic: For BRILMA block, 0.4 ml/kg of 0.3% ropivacaine will be injected between the medial aspect of the serratus anterior muscle and the external intercostal muscle (thoraco-dentate space) covering 3 intercostal spaces (3rd, 4th and 5th). A catheter will be placed in the 4th intercostal space that will provide analgesia for the first three postoperative days. The cryoanalgesia technique will be performed by the surgeon before the closure of the minithoracotomy, on the right hemithorax. An external cryogenic system AtriCure CE0123 will be used for use with cryoICE AtriCure 10 cm Cryoablation Probe, CE2797. The cryoprobe will be applied on the lower costal ridge at the level of the 3rd, 4th and 5th intercostal spaces.
Postoperative pain (location and intensity) will be evaluated using a Simple Verbal Scale from 0 (no pain) to 10 (maximum imaginable pain). The need for rescue analgesia will be collected during hospital stay. At 24, 48 and 72 h after surgery and at hospital discharge, the maximum score of pain experienced by the patient (at rest and deep inspiration) will be collected. At hospital discharge, an investigator will evaluate the occurrence of neuropathic pain using the DN-4 scale (Douleur Neuropatique in 4 questions). In addition, the patient will complete these four questions 30 days after surgery and the results will be known by the responsible researcher
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Susana González Súarez, PhD
- Phone Number: 6004 934893000
- Email: susana.gonzalez@vallhebron.cat
Study Locations
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Cataluña
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Barcelona, Cataluña, Spain, 08035
- Recruiting
- Susana González Suárez
-
Contact:
- Susana González Súarez, PhD
- Phone Number: 6004 934893000
- Email: susagonz3@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients > 18 years of age, underwent cardiac surgery by minithoracotomy
- Cardiac surgery
- Minithoracotomy
Exclusion Criteria:
- <18 years old
- Patients undergoing cardiac surgery by sternotomy
- Patients with regular consumption of analgesics,
- Patients with neurological diseases with altered level of consciousness
- Patients with previous neuropathic pain.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
BRILMA block
Patients receiving BRILMA blockade.
BRILMA blockade will be performed at the end of surgery at the level of the 3rd, 4th and 5th intercostal spaces of the right hemithorax.
|
For BRILMA block, 0.4 ml/kg of 0.3% ropivacaine will be injected and a catheter will be placed on the 4th intercostal space after surgery.
For intercostal nerve cryoanalgesia an external cryogenizer system will be used during surgery
|
Intercostal nerve cryoanalgesia
Patients receiving intercostal nerve cryoanalgesia.
The cryoanalgesia technique will be performed by the surgeon before the closure of the minithoracotomy, at the level of the 3rd, 4th and 5th intercostal spaces on the right hemithorax.
|
For BRILMA block, 0.4 ml/kg of 0.3% ropivacaine will be injected and a catheter will be placed on the 4th intercostal space after surgery.
For intercostal nerve cryoanalgesia an external cryogenizer system will be used during surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Postoperative analgesia
Time Frame: From day of surgery until 30 days after surgery
|
Compare the postoperative analgesia provided by BRILMA block and intercostal nerve cryoanalgesia in patients undergoing cardiac surgery by minitoractomia: Compare postoperative analgesia provided by BRILMA block and intercostal nerve cryoanalgesia in patients undergoing minithoractomy cardiac surgery:
|
From day of surgery until 30 days after surgery
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neuropathic pain
Time Frame: 30 days after surgery
|
Determine the percentage of patients with neuropathic pain at hospital discharge and 30 days after surgery using the DN-4 scale developed by Bouhassira et al. in 2005
|
30 days after surgery
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Khanbhai M, Yap KH, Mohamed S, Dunning J. Is cryoanalgesia effective for post-thoracotomy pain? Interact Cardiovasc Thorac Surg. 2014 Feb;18(2):202-9. doi: 10.1093/icvts/ivt468. Epub 2013 Nov 11.
- Saravanan R, Venkatraman R, Karthika U. Comparison of Ultrasound-Guided Modified BRILMA Block with Subcostal Transversus Abdominis Plane Block for Postoperative Analgesia in Laparoscopic Cholecystectomy - A Randomized Controlled Trial. Local Reg Anesth. 2021 Jul 2;14:109-116. doi: 10.2147/LRA.S316320. eCollection 2021.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- PR(AG)324/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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