Intercostal Nerve Cryoanalgesia vs BRILMA Block for Minithoracotomy on Cardiac Surgery

NCT06086535 | Completed

• 1 other identifier: PR(AG)324/2022
• Study Type: observational
• Target: 63
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Post Operative Pain

Keywords

intercostal nerve cryoanalgesia; BRILMA block; minithoracotomy; cardiac surgery; postoperative analgesia

Outcome Measures

Primary Outcomes (1)

• 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: 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

  From day of surgery until 30 days after surgery

Secondary Outcomes (1)

• Neuropathic pain

  30 days after surgery

Study Arms (2)

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.

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.

Procedure: Intercostal nerve cryoanalgesia vs BRILMA blockade

Interventions

Intercostal nerve cryoanalgesia vs BRILMA blockade PROCEDURE

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

BRILMA block; Intercostal nerve cryoanalgesia

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery by minithoracotomy

You may qualify if:

• Patients \> 18 years of age, underwent cardiac surgery by minithoracotomy
• Cardiac surgery
• Minithoracotomy

You may not qualify if:

• \<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.

Sponsors & Collaborators

• Hospital Universitari Vall d'Hebron Research Institute: lead

Study Sites (1)

Susana González Suárez

Barcelona, Catalonia, 08035, Spain

Location

Related Publications (2)

• 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.

  PMID: 24218494 RESULT

• 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.

  PMID: 34239324 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: October 17, 2023
• Study Start: October 30, 2023
• Primary Completion: June 20, 2025
• Study Completion: July 20, 2025
• Last Updated: November 28, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)