CompletedNot Applicable

Cryoablation of Intercostal Nerves for Pain Management in Early Postoperative Period in Patients With Minimally Invasive Mitral Valve Surgery

Russia30 participantsStarted 2024-03-10

Plain-language 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 according to VAS in patients undergoing minimally invasive mitral valve surgery. To obtain preliminary data for planning a subsequent larger prospective randomized trial.

Who can participate

SexALL

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Inclusion criteria: * Written informed consent; * Minimally invasive mitral valve surgery. Non-inclusion criteria: * patient refusal; * pregnancy; * treatment with antidepressants or epileptic drugs; * depression, which can significantly affect the perception of pain; * chronic use of analgesics; * participation in competing randomized clinical trials. Exclusion criteria: \- Extended mechanical ventilation, more than 12 hours.

What they're measuring

Opioid analgesic consumption

Timeframe: 48 hours after surgery

Trial details

NCT IDNCT06443931

SponsorMeshalkin Research Institute of Pathology of Circulation

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2025-10-31

View on ClinicalTrials.gov More Mitral Regurgitation trials