Post Operative PainNCT06086535
Intercostal Nerve Cryoanalgesia vs BRILMA Block for Minithoracotomy on Cardiac Surgery
An observational study of Post Operative Pain, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
Trial summary
Patients undergoing cardiac surgery by minithoracomy present severe acute postoperative pain. Cryoanalgesia of the intercostal nerves and BRILMA block can provide a solution for this postoperative pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Operative Pain
- What is being tested?
- Intercostal nerve cryoanalgesia vs BRILMA blockade
- Type of treatment
- Surgery or procedure
- How many people
- 63 participants
- Where
- 1 siteSpain
- Study dates
- 30 Oct 2023to 20 Jul 2025
- Phase
- Observational
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing cardiac surgery by minithoracotomy
Who may be able to join
- Patients > 18 years of age, underwent cardiac surgery by minithoracotomy
- Cardiac surgery
- Minithoracotomy
Who cannot join
- <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.
Trial locations and contacts
1 site in 1 country.
About this study
Patients undergoing cardiac surgery by minithoracomy present severe acute postoperative pain. Cryoanalgesia of the intercostal nerves and BRILMA block can provide a solution for this postoperative pain. The main aim of this study is to compare the postoperative analgesia provided by BRILMA block and intercostal nerve cryoanalgesia in patients undergoing cardiac surgery by minitoractomia.
Read the 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
- Conditions
- Post Operative Pain
- Being tested
- Intercostal nerve cryoanalgesia vs BRILMA blockade
- Keywords
- intercostal nerve cryoanalgesia, BRILMA block, minithoracotomy, cardiac surgery, postoperative analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intercostal nerve cryoanalgesia vs BRILMA blockadeProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Intercostal nerve cryoanalgesia vs BRILMA blockade | |
| 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. Receives: Procedure: Intercostal nerve cryoanalgesia vs BRILMA blockade |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative analgesia
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:
- Determine the location of postoperative pain: in the surgical incision, shoulder, back
- Determine the intensity of postoperative pain. Evaluation using simple verbal scale (SVS) of pain: 0 (no pain), 10 (maximum pain) after orotracheal extubation, 24 and 48 hours after surgery and at hospital discharge
Measured: From day of surgery until 30 days after surgery
Secondary outcomes (1)
Neuropathic pain
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
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2023
- Study start30 Oct 2023
- Primary completion20 Jun 2025
- Study completion20 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post Operative PainStudies of the same condition, open and under way.
- More trials run by Hospital Universitari Vall d'Hebron Research InstituteThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06086535
- Sponsor's protocol ID
- PR(AG)324/2022
- Status last verified
- Aug 2025
- First submitted
- 18 Feb 2023
- Last updated
- 28 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 24218494Saravanan 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.
PubMed 34239324Gonzalez-Suarez S, Rios-Barrera R, Fornells PB, Ramisa BC, Vigil-Escalera CM, Traore Kone CM, Liyanage IMD, Fernandez MMP, Rodriguez-Lecoq R. Continuous serratus-intercostal plane block versus intercostal cryoanalgesia for postoperative pain after minimally invasive cardiac surgery: a prospective comparative observational study. BMC Anesthesiol. 2026 May 23;26(1):427. doi: 10.1186/s12871-026-03936-3.
PubMed 42177418
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intercostal Nerve Cryoanalgesia vs BRILMA Block for Minithoracotomy on Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06086535
- Acronym / sponsor ID
- PR(AG)324/2022
- Conditions
- Post Operative Pain
- Keywords
- intercostal nerve cryoanalgesia, BRILMA block, minithoracotomy, cardiac surgery, postoperative analgesia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Hospital Universitari Vall d'Hebron Research InstituteUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 20 Jun 2025 (actual)
- Study completion
- 20 Jul 2025 (actual)
- First posted
- 17 Oct 2023 (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.
Patients undergoing cardiac surgery by minithoracomy present severe acute postoperative pain. Cryoanalgesia of the intercostal nerves and BRILMA block can provide a solution for this postoperative pain. The main aim of this study is to compare the postoperative analgesia provided by BRILMA block and intercostal nerve cryoanalgesia in patients undergoing cardiac surgery by minitoractomia.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BRILMA block | – | Procedure: Intercostal nerve cryoanalgesia vs BRILMA blockadePatients 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. |
| Intercostal nerve cryoanalgesia | – | Procedure: Intercostal nerve cryoanalgesia vs BRILMA blockadePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing cardiac surgery by minithoracotomy
Key inclusion criteria (3 listed)
- Patients > 18 years of age, underwent cardiac surgery by minithoracotomy
- Cardiac surgery
- Minithoracotomy
Key exclusion criteria (5 listed)
- <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.
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 |
|---|---|---|
| Intercostal nerve cryoanalgesia vs BRILMA blockadeFor 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 | Procedure or surgery | BRILMA block, Intercostal nerve cryoanalgesia |
Primary outcome
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: 1. Determine the location of postoperative pain: in the surgical incision, shoulder, back 2. Determine the intensity of postoperative pain. Evaluation using simple verbal scale (SVS) of pain: 0 (no pain), 10 (maximum pain) after orotracheal extubation, 24 and 48 hours after surgery and at hospital discharge
1 secondary outcome
Neuropathic pain
Time frame: 30 days after surgery
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 28 Nov 2025.
- Results publication: PubMed 24218494Khanbhai 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.
- Results publication: PubMed 34239324Saravanan 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.
- Derived from this study: PubMed 42177418Gonzalez-Suarez S, Rios-Barrera R, Fornells PB, Ramisa BC, Vigil-Escalera CM, Traore Kone CM, Liyanage IMD, Fernandez MMP, Rodriguez-Lecoq R. Continuous serratus-intercostal plane block versus intercostal cryoanalgesia for postoperative pain after minimally invasive cardiac surgery: a prospective comparative observational study. BMC Anesthesiol. 2026 May 23;26(1):427. doi: 10.1186/s12871-026-03936-3.
- Individual participant dataSharing planned: No
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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?
An observational study of Post Operative Pain, run by Hospital Universitari Vall d'Hebron Research Institute at 1 site in Spain.
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 3 inclusion and 5 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 28 Nov 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 Spain. 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?
Postoperative analgesia (time frame: From day of surgery until 30 days 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 NCT06086535, which also lists 3 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 28 Nov 2025.