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

Primary Purpose

Pain, Postoperative, Heart Valve Diseases

Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Continuous Erector spinae block
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative focused on measuring erector spinae plane block, thoracic surgery, cardiac surgical procedures, pain, postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Subjects undergoing minimally invasive cardiac surgery
  • Acceptance to participate in the study
  • ASA physical status II-IV
  • Age > 18 years

Exclusion Criteria:

  • Refusal to participate in the study
  • Allergy to local anesthetics
  • History of substance abuse

Sites / Locations

  • Hospital ClinicRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Continuous unilateral ESP block

Arm Description

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.

Outcomes

Primary Outcome Measures

Assesment of postoperative analgesia
Post operative pain scores will be recorded with a NRS(numerical rating scala) from 0 to 10 ( 0=no pain, 10= pain as bad as can be) worst score at 12 hrs, 24 hrs and 48 hrs period will be scored.
Morphine consumption
total morphine consumption in milligrams at 12 hrs, 24 hrs and 48 hrs will be scored.

Secondary Outcome Measures

Full Information

First Posted
July 2, 2019
Last Updated
July 10, 2019
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT04011501
Brief Title
Erector Spinae Plane Block for Minimal Invasive Cardiac Surgery (Heart-Port).
Acronym
ESP
Official Title
Erector Spinae Plane Block for Minimal Invasive Cardiac Surgery (Heart-Port).
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 7, 2019 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
October 1, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Minimally invasive cardiac surgery is performed through a right thoracotomy, the pain management of this surgery is of great importance. Regional techniques such as thoracic epidural anesthesia or paravertebral block are excellent techniques for the management of postoperative pain in thoracic surgery but they have disadvantages that make it difficult to use in this surgery. On the one hand, anticoagulation in these patients increases the risk of complications related to the use of neuraxial techniques and, on the other hand, the technical difficulty of paravertebral block. The erector of the spine block is a technically simple block and with a low risk of associated complications. The aim of the study is to evaluate the feasibility and benefits in the relationship of postoperative pain management in patients undergoing minimally invasive cardiac surgery when using continuous unilateral blockade of the erector in a small cohort of patients.
Detailed Description
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: 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. 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. 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. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Heart Valve Diseases
Keywords
erector spinae plane block, thoracic surgery, cardiac surgical procedures, pain, postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Continuous unilateral ESP block
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Continuous Erector spinae block
Intervention Description
Erector spine block and catheter placement will be performed for continuous analgesia prior to the surgical procedure.A initial bolus of 20 ml of Levobupivacaine 0.25% will be administered. Subsequently a 22G catheter will be introduced. 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.
Primary Outcome Measure Information:
Title
Assesment of postoperative analgesia
Description
Post operative pain scores will be recorded with a NRS(numerical rating scala) from 0 to 10 ( 0=no pain, 10= pain as bad as can be) worst score at 12 hrs, 24 hrs and 48 hrs period will be scored.
Time Frame
up to 48 hours
Title
Morphine consumption
Description
total morphine consumption in milligrams at 12 hrs, 24 hrs and 48 hrs will be scored.
Time Frame
up to 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects undergoing minimally invasive cardiac surgery Acceptance to participate in the study ASA physical status II-IV Age > 18 years Exclusion Criteria: Refusal to participate in the study Allergy to local anesthetics History of substance abuse
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Xavier Sala-Blanch, MD
Phone
346263536009
Email
xavi.sala.blanch@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xavier Sala-Blanch, MD
Organizational Affiliation
Hospital Clinic of Barcelona
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
0836
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier Sala-Blanch, MD
Phone
34626353609
Email
xavi.sala.blanch@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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

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