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

NCT04338984 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 86

Last updated 2022-08-12

No results posted yet for this study

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

Interventions

DRUG

General anesthetic

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.

DRUG

Ropivacaine 0.5% Injectable Solution

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%.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Serban Ion Bubenek Turconi, Professor · Prof. Dr. C.C. Iliescu Institute for Emergency Cardiovascular Diseases

  • Dana Tomescu, Professor · Fundeni Clinical Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-01
Primary Completion
2021-04-30
Completion
2021-05-31

Countries

  • Romania

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04338984 on ClinicalTrials.gov