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ESP Block in Robotic Cardiac Surgery

Primary Purpose

Heart Valve Diseases, Postoperative Pain, Acute, Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
ESP Block
Morphine injection
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Valve Diseases focused on measuring Robotic Cardiac Surgery, ESP Block, Postoperative Pain, Heart Valve disease

Eligibility Criteria

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

Inclusion Criteria: Robotic Cardiac Surgery Accepts to participate Exclusion Criteria: Use of other regional anesthesia technics Presence of chronic Pain Psychiatric pathology, drug abuse Allergy or intolerance to local anesthetics

Sites / Locations

  • Hospital Clínic de BarcelonaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Morphine infusion

ESP Block analgesia

Arm Description

IV morphine 50mcg/kg/h infusion with Patient Controlled Analgesia extra bolus on demand of 1mg (lockout interval 20 minutes), and paracetamol 1g every 8 hours.

After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed. An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Patient Controlled Analgesia pump will be connected with 1mg IV morphine bolus on demand, and paracetamol 1g every 8 hours, is also delivered.

Outcomes

Primary Outcome Measures

Accumulated opioid dose 12h
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 24h
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Accumulated opioid dose 48h
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Visual Analogic Scale 12h
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Visual Analogic Scale 24h
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Visual Analogic Scale 48h
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.

Secondary Outcome Measures

EQ 5-Dimensions 5-Levels
Quality of Life measure with EQ 5D 5L scale, created by the Euro QL group and used to measure life quality, its a scale describing 5 dimensions of life (Mobility, Self care, General activity, pain and discomfort, anxiety and depression) in 5 levels of comfort/discomfort (Score of 1 in each dimensions describes the most comfort). It can be expressed separately or by combining them into an index generated with a standard calculator provided by the EQL group.
Brief Pain Scale
Pain presence and its characteristics 3 months after surgery described by the brief pain scale. This standard scale describes the pain intensity from 1 to 10 (being 10 the most intense pain) and and DN4 scale will be performed.
Neuropathic pain assessment
When pain is present, assessment for neuropathic pain characteristics will be assessed using the Douleur neuropathique 4 (DN4) scale, spanish version. This scale assess 10 characteristics of pain, with a maximum score of 10, minimum of 0. Interpreted as positive (neuropathic pain likely) with a score of 7 or more.

Full Information

First Posted
December 19, 2022
Last Updated
January 17, 2023
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT05702151
Brief Title
ESP Block in Robotic Cardiac Surgery
Official Title
Erector Spinae Plane Block in Robotic Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 22, 2022 (Actual)
Primary Completion Date
March 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
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
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Control group will receive standard of care pain management with acetaminophen and morphine in PCA pump, and the intervention group will receive an erector spinae plane block with a continous infusion of local anesthetic. At 3 months the patients will be contacted to assess for pain and ask them for they life quality.
Detailed Description
Patients undergoing cardiac robotic surgery will receive different pain management after being randomized in 2 groups. Before the surgery and after checking eligibility criteria and exclusion criteria the patients will be asked to enroll to the study. If the agree to participate, they will sign de informed consent and fill the EQL 5D-5L questionnaire. The day of the surgery, the perioperative process will be performed as usual unless the interventions detailed in this description. Patients will be transferred to the surgical area, enter to the operating room, monitored and general anesthesia will be performed. Standard postoperative analgesia group will receive a at the end of the surgery a bolus of IV morphine 0,05mg/kg, followed with infusion of IV morphine 0,25mg/h in Patient Controlled Analgesia protocol (extra bolus on demand of 1mg with lockout interval 20 minutes), and paracetamol 1g every 8 hours. The experimental group will receive the standard analgesia and an ESP Block. In this group, after the induction of general anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an ipsilateral Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed in this plane. An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Both groups of patients will emerge from anesthesia in the operative room or at the intensive care unit in the first 6 postoperative hours if possible. After the surgery they will be transfered to the intensive care unit where vital signs will be monitored continuously. The pain intensity and the total required opioid dose will be registered at 12, 24 and 48 postoperative hours. After acute phase of postoperative pain and typically until chest drainages are retired, the ESP catheter and the IV morphine will be withdrawn. After discharge by usual criteria, 3 months after the surgery patients will be contacted by telephone. Quality of life, pain and if present, its characteristics will be assessed.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Valve Diseases, Postoperative Pain, Acute, Analgesia
Keywords
Robotic Cardiac Surgery, ESP Block, Postoperative Pain, Heart Valve disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective Randomized Open Clinical Trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Morphine infusion
Arm Type
Active Comparator
Arm Description
IV morphine 50mcg/kg/h infusion with Patient Controlled Analgesia extra bolus on demand of 1mg (lockout interval 20 minutes), and paracetamol 1g every 8 hours.
Arm Title
ESP Block analgesia
Arm Type
Experimental
Arm Description
After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed. An infusion of ropivacaine 0.16% at 10ml/h is started in the operating room. Patient Controlled Analgesia pump will be connected with 1mg IV morphine bolus on demand, and paracetamol 1g every 8 hours, is also delivered.
Intervention Type
Procedure
Intervention Name(s)
ESP Block
Other Intervention Name(s)
Erector spinae Plane Block
Intervention Description
After induction of anesthesia in the operating room, the patient is positioned in lateral decubitus. Under strict aseptic conditions, and guided by ultrasound, an Erector Spinae Plane block is performed injecting ropivacaine 0.2% 20ml, and a catheter is placed. Ropivacaine 0.2% infusion at a 10ml/h rate is started during the surgery.
Intervention Type
Drug
Intervention Name(s)
Morphine injection
Other Intervention Name(s)
Intravenous opioid infusion analgesia and paracetamol
Intervention Description
Intravenous morphine infusion 50mcg/kg/h with Patient Controlled Analgesia extra bolus on demand (1mg bolus with 20 minutes lockout time), and paracetamol 1g every 8 hours.
Primary Outcome Measure Information:
Title
Accumulated opioid dose 12h
Description
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Time Frame
12 postoperative hours
Title
Accumulated opioid dose 24h
Description
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Time Frame
24 ostoperative hours
Title
Accumulated opioid dose 48h
Description
Morphine PCA pump will measure the accumulated dose of morphine, this is an objective measure of how many times the patients have had uncontrolled pain. Expressed in mg. If the patient has received other opioid besides of morphine it will be transformed using equivalent morphine dose and added to the total dose.
Time Frame
48 postoperative hours
Title
Visual Analogic Scale 12h
Description
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Time Frame
12 postoperative hours
Title
Visual Analogic Scale 24h
Description
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Time Frame
24 postoperative hours
Title
Visual Analogic Scale 48h
Description
Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.
Time Frame
48 postoperative hours
Secondary Outcome Measure Information:
Title
EQ 5-Dimensions 5-Levels
Description
Quality of Life measure with EQ 5D 5L scale, created by the Euro QL group and used to measure life quality, its a scale describing 5 dimensions of life (Mobility, Self care, General activity, pain and discomfort, anxiety and depression) in 5 levels of comfort/discomfort (Score of 1 in each dimensions describes the most comfort). It can be expressed separately or by combining them into an index generated with a standard calculator provided by the EQL group.
Time Frame
Preoperative and 3 months after surgery
Title
Brief Pain Scale
Description
Pain presence and its characteristics 3 months after surgery described by the brief pain scale. This standard scale describes the pain intensity from 1 to 10 (being 10 the most intense pain) and and DN4 scale will be performed.
Time Frame
3 months after surgery
Title
Neuropathic pain assessment
Description
When pain is present, assessment for neuropathic pain characteristics will be assessed using the Douleur neuropathique 4 (DN4) scale, spanish version. This scale assess 10 characteristics of pain, with a maximum score of 10, minimum of 0. Interpreted as positive (neuropathic pain likely) with a score of 7 or more.
Time Frame
3 postoperative months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Robotic Cardiac Surgery Accepts to participate Exclusion Criteria: Use of other regional anesthesia technics Presence of chronic Pain Psychiatric pathology, drug abuse Allergy or intolerance to local anesthetics
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Aliaga, MD
Phone
932275400
Ext
5558
Email
aliaga@clinic.cat
First Name & Middle Initial & Last Name or Official Title & Degree
Ricard Navarro, PhD
Email
rnavarr1@clinic.cat
Facility Information:
Facility Name
Hospital Clínic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Aliaga Medina, MD
First Name & Middle Initial & Last Name & Degree
Ricard Navarro, PhD
First Name & Middle Initial & Last Name & Degree
Stefano Italiano, PhD
First Name & Middle Initial & Last Name & Degree
Pau Mingarro Cubells, MD
First Name & Middle Initial & Last Name & Degree
Felipe Unigarro, MD

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to share the IPD, unless requested
Citations:
PubMed Identifier
22980395
Citation
Rovira Canudas I. [Postoperatory analgesia for minimally invasive cardiac surgery: which is the ideal technique?]. Rev Esp Anestesiol Reanim. 2012 Nov;59(9):467-9. doi: 10.1016/j.redar.2012.07.010. Epub 2012 Sep 12. No abstract available. Spanish.
Results Reference
background
PubMed Identifier
22058144
Citation
Freise H, Van Aken HK. Risks and benefits of thoracic epidural anaesthesia. Br J Anaesth. 2011 Dec;107(6):859-68. doi: 10.1093/bja/aer339. Epub 2011 Nov 4.
Results Reference
background
PubMed Identifier
29169795
Citation
D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.
Results Reference
background
PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
background
PubMed Identifier
30292068
Citation
Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.
Results Reference
background

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ESP Block in Robotic Cardiac Surgery

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