Nociception-directed Erector Muscle Spinae Plane Block in Open Heart Surgery

NCT04338984 | Completed Phase 4 DMC

• 1 other identifier: 18750
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

Brief Summary

With the advent of ultrasound (US) guidance, use of regional anaesthesia (RA) is poised to grow and evolve. Recently, cardiac surgery has benefited from newer US guided interfascial techniques as they promise to fulfil all the prerequisites of an enhanced recovery after surgery (ERAS) strategy(1,2). The erector spinae plane (ESP) block represents such an alternative(3). Speed and ease of performance are paramount to encourage spread of its use. Hence, the scope of this trial is to investigate the effects on perioperative opioid consumption and several other secondary outcomes of a minimalist approach encompassing a bilateral single shot ESP block when applied as an adjunct to general anaesthesia.

Conditions

Regional Anesthesia; Heart Surgery

Keywords

erector spinae plane block; fast-track; rehabilitation; opioid

Outcome Measures

Primary Outcomes (1)

• Intraoperative fentanyl consumption (µg/kg/h)

  Goal directed monitoring of nociception with NOL index PMD200 (+/- variation of mean arterial blood pressure and heart rate)

  during intraoperative period

Secondary Outcomes (12)

• Fentanyl (µg/kg/h) consumption

  until large vessel cannulation

• Morphine consumption (mg/kg)

  24 hours and 48 hours after surgery

• Quality of postoperative analgesia

  6 hours, 12 hours, 24 hours and 48 hours after extubation/ICU admission and 1 hour after drain removal

• Time to extubation

  up to 24 hours after surgery

• Norepinephrine dose (mcg/kg/h)

  intraoperative, 6 hours and 12 hours after surgery

Study Arms (2)

General anesthesia alone (AG)

ACTIVE COMPARATOR

Opioid based analgesia: Fentanyl 5 mcg/kg is standard dose at induction. Further dosing is steered according to NOL index and ancillaries such as heart rate and mean arterial blood pressure (± 20% of preoperative baseline). Postoperatively, analgesia comprises on-demand morphine and regularly dosed paracetamol.

Drug: General anesthetic

Erector Spinae Plane Block and General Anaesthesia (ESPAG)

EXPERIMENTAL

Bilateral single shot erector spinae plane block with Ropivacaine 0.5% (total dose 3mg/kg) and Dexamethasone 8mg per every 20ml Ropivacaine 0.5% is performed before induction of general anaesthesia. A minimum 30 minutes interval is allowed before skin incision. Fentanyl 5 mcg/kg is standard dose at induction; rescue dosing is steered according to NOL index and ancillaries such as heart rate and mean arterial blood pressure (± 20% of preoperative baseline). Postoperatively, analgesia comprises on-demand morphine and regularly dosed paracetamol.

Drug: Ropivacaine 0.5% Injectable Solution

Interventions

General anesthetic DRUG

Fentanyl is administered at induction - standard dose 5 mcg/kg. Further dosing is based on a multiderivative assessment of nociception (NOL index) and ancillaries such as heart rate and mean arterial blood pressure.

Also known as: Fentanyl based general anaesthesia

General anesthesia alone (AG)

Ropivacaine 0.5% Injectable Solution DRUG

Bilateral single shot erector spinae plane block is performed before induction of general anaesthesia. Ropivacaine 0.5% total dose 3mg/kg with Dexamethasone 8mg/20 ml Ropivacaine 0.5%.

Also known as: Erector Spinae Plane Block

Erector Spinae Plane Block and General Anaesthesia (ESPAG)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed Consent.
• Elective heart surgery with sternotomy and bypass.
• Hemodynamic stability prior to induction (no chest pain, SAP \> 100 mmHg, MAP ≥ 60 mmHg, 50 \< HR \< 100 bpm).
• Sinus rhythm.

You may not qualify if:

• Known allergy to any of the medications used in the study.
• BMI \> 35.
• Patient refusal to participate in the study.
• Coagulopathy (INR \> 1.5, APTT \> 45, Fibrinogen \< 150 mg/dl).
• Non-elective/emergent and/or redo surgery.
• ASA ≥ 4.
• Any preoperative hemodynamic support (mechanical or pharmaceutical).
• Severe LV dysfunction (LVEF ≤ 30%).
• Severe RV dysfunction or PHT (RVFAC ≤ 25%).

Sponsors & Collaborators

• Institutul de Urgenţă pentru Boli Cardiovasculare Prof.Dr. C.C. Iliescu: lead

Study Sites (1)

Prof Dr CC Iliescu Institute for Emergency Cardiovascular Diseases

Bucharest, 022328, Romania

Location

Related Publications (3)

• Smith LM, Barrington MJ; St Vincent's Hospital, Melbourne. Ultrasound-guided blocks for cardiovascular surgery: which block for which patient? Curr Opin Anaesthesiol. 2020 Feb;33(1):64-70. doi: 10.1097/ACO.0000000000000818.

  PMID: 31833864 BACKGROUND

• Kelava M, Alfirevic A, Bustamante S, Hargrave J, Marciniak D. Regional Anesthesia in Cardiac Surgery: An Overview of Fascial Plane Chest Wall Blocks. Anesth Analg. 2020 Jul;131(1):127-135. doi: 10.1213/ANE.0000000000004682.

  PMID: 32032103 BACKGROUND

• Macaire P, Ho N, Nguyen T, Nguyen B, Vu V, Quach C, Roques V, Capdevila X. Ultrasound-Guided Continuous Thoracic Erector Spinae Plane Block Within an Enhanced Recovery Program Is Associated with Decreased Opioid Consumption and Improved Patient Postoperative Rehabilitation After Open Cardiac Surgery-A Patient-Matched, Controlled Before-and-After Study. J Cardiothorac Vasc Anesth. 2019 Jun;33(6):1659-1667. doi: 10.1053/j.jvca.2018.11.021. Epub 2018 Nov 19.

  PMID: 30665850 BACKGROUND

MeSH Terms

Interventions

Anesthetics, General; Ropivacaine

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Serban Ion Bubenek Turconi, Professor

  Prof. Dr. C.C. Iliescu Institute for Emergency Cardiovascular Diseases

  STUDY DIRECTOR

• Dana Tomescu, Professor

  Fundeni Clinical Institute

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Cardiovascular Anaesthesia and ICM

Study Record Dates

• First Submitted: April 2, 2020
• First Posted: April 8, 2020
• Study Start: December 1, 2019
• Primary Completion: April 30, 2021
• Study Completion: May 31, 2021
• Last Updated: August 12, 2022

Record last verified: 2022-08

Locations

RO (1)