ESP Block in Robotic Cardiac Surgery

NCT05702151 | Unknown

• 1 other identifier: ESProbot001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Heart Valve Diseases; Postoperative Pain, Acute; Analgesia

Keywords

Robotic Cardiac Surgery; ESP Block; Postoperative Pain; Heart Valve disease

Outcome Measures

Primary Outcomes (6)

• 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.

  12 postoperative hours

• 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.

  24 ostoperative hours

• 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.

  48 postoperative hours

• Visual Analogic Scale 12h

  Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.

  12 postoperative hours

• Visual Analogic Scale 24h

  Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.

  24 postoperative hours

• Visual Analogic Scale 48h

  Pain will be measured with Visual analogic scale and recorded. It has numeric discrete ranging from 0 to 10.

  48 postoperative hours

Secondary Outcomes (3)

• EQ 5-Dimensions 5-Levels

  Preoperative and 3 months after surgery

• Brief Pain Scale

  3 months after surgery

• Neuropathic pain assessment

  3 postoperative months

Study Arms (2)

Morphine infusion

ACTIVE COMPARATOR

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.

Drug: Morphine injection

ESP Block analgesia

EXPERIMENTAL

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.

Procedure: ESP Block; Drug: Morphine injection

Interventions

ESP Block PROCEDURE

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.

Also known as: Erector spinae Plane Block

ESP Block analgesia

Morphine injection DRUG

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.

Also known as: Intravenous opioid infusion analgesia and paracetamol

ESP Block analgesia; Morphine infusion

Eligibility Criteria

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

You may qualify if:

• Robotic Cardiac Surgery
• Accepts to participate

You may not qualify if:

• Use of other regional anesthesia technics
• Presence of chronic Pain
• Psychiatric pathology, drug abuse
• Allergy or intolerance to local anesthetics

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clínic de Barcelona

Barcelona, 08036, Spain

RECRUITING

Related Publications (5)

• 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.

  PMID: 22980395 BACKGROUND

• 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.

  PMID: 22058144 BACKGROUND

• 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.

  PMID: 29169795 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

• 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.

  PMID: 30292068 BACKGROUND

MeSH Terms

Conditions

Heart Valve Diseases; Pain, Postoperative; Agnosia

Interventions

Morphine; Acetaminophen

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Jorge Aliaga, MD

CONTACT

932275400; aliaga@clinic.cat

Ricard Navarro, PhD

CONTACT

rnavarr1@clinic.cat

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective Randomized Open Clinical Trial

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: January 27, 2023
• Study Start: December 22, 2022
• Primary Completion: March 1, 2024
• Study Completion: June 1, 2024
• Last Updated: January 27, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)