Suspended

ESPErector Spinae Plane Block for Minimal Invasive Cardiac Surgery (Heart-Port).

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What is being tested

Continuous Erector spinae block

Procedure
Who is being recruted

Cardiovascular Diseases+7

+ Heart Diseases

+ Heart Valve Diseases

Over 18 Years
+7 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: May 2019
See protocol details

Summary

Principal SponsorHospital Clinic of Barcelona
Study ContactXavier Sala-Blanch, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: May 7, 2019

Actual date on which the first participant was enrolled.

An observational study of a series of 20 cases will be carried out based on the casuistry of minimally invasive cardiac surgery of the investigator's center. The performance of analgesic blockade called ESP with catheter placement for continuous analgesia, at the level of the 6th thoracic vertebra in adult patients, ASA physical status I-III, which will undergo minimally invasive cardiac surgery, will be part of the multimodal analgesia strategy. After compliance with the inclusion criteria, with the acceptance and signature of the informed consent by the participating patients, the following procedure will be followed: 1. Patients will be routinely assessed by an anesthesiologist of the service, later they will enter the operating room, where the vital signs will be monitored and the usual anesthetic technique will be used for minimally invasive cardiac surgery, that is, general anesthesia. 2. The erector block of the spine and the catheter installation for continuous analgesia will be performed in the operating room, after induction of general anesthesia. Patients will be placed in the left lateral decubitus position, and under sterile technique with asepsis of the thoracolumbar area, erector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure. The spinal erector musculature will be located at the level of the transverse process of the 6th left thoracic vertebra.Initially a volume of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G (Gauge) catheter will be introduced and fixed 10-12 cm from the skin. The surgery will begin according to the usual practice. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution. 3. During and after the surgery, the intravenous analgesic protocols already established by the anesthesiology service will be used, so that the realization of the blocking in the plane of the erector musculature will not modify the prescribed analgesic or rescue regimens employees for minimally invasive cardiac surgery, these include the use of an opioid pump on demand by the patient. After the surgery, the intensity of postoperative pain during the first 48 hours will be observed and recorded by the Acute Pain Unit of the Anaesthesiology Service, blind to the study objectives, following its usual practice and assessment. 4. Researchers will record those variables aimed at evaluating the intensity of acute postoperative pain after minimally invasive cardiac surgery after performing spinal erector block and catheter placement for continuous analgesia in the study period, such as NRS (Numeric rating scale), Paired intravenous analgesia and opioid use. These results will be included, anonymously, in an Excel database made for this purpose for further analysis. The variables will be recorded in a single intervention

Official TitleErector Spinae Plane Block for Minimal Invasive Cardiac Surgery (Heart-Port).
NCT04011501
Principal SponsorHospital Clinic of Barcelona
Study ContactXavier Sala-Blanch, MD
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

20 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Cardiovascular DiseasesHeart DiseasesHeart Valve DiseasesNeurologic ManifestationsPainPain, PostoperativePathologic ProcessesPostoperative ComplicationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Criteria

4 inclusion criteria required to participate
Subjects undergoing minimally invasive cardiac surgery

Acceptance to participate in the study

ASA physical status II-IV

Age > 18 years

3 exclusion criteria prevent from participating
Refusal to participate in the study

Allergy to local anesthetics

History of substance abuse

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Erector spine block and catheter placement will be performed for continuous analgesia on this group of patients undergoing minimally invasive cardiac surgery. Initially a volume of 20 ml of Levobupivacaine 0.25% will be administered and subsequently a 22G catheter will be introduced and fixed 10-12 cm from the skin. At the end of the surgery, an elastomeric pump will be installed at a flow rate of 7 ml / hr with a 1.3% Ropivacaine solution.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

Hospital Clinic

Barcelona, SpainOpen Hospital Clinic in Google Maps
SuspendedOne Study Center