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Comparison Erect Spine in Cardiac Surgery

NCT04313959 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-07-18

No results posted yet for this study

Summary

Open cardiac surgeries are characterized by the increased use of opioids and longer extubation times, being post-sternotomy pain one of the causes of greater patient discomfort, plexus blockages have been used more frequently given the good results of anatomical studies and case series that are just beginning to be published. however, there is not enough data to convince the scientific community of its advantages, continuing to carry out its performance due to lack of evidence. Dexamethasone also shows an excellent result blocking the inflammatory chain and it was evidenced that it prolongs the time of blockages when used perineurally in the plexus blockages. This study wants to show the improvement of pain in patients who undergo this type of surgery and also show the advantages of a longer blockage, which can reduce use of analgesic and opioids, as well as decrease the time of hospitalization This is a double-blinded, randomized, clinical trial designed to determine the efficacy of spine erector whit dexamethasone gives more duration of the blockage and less pain after cardiac surgery.

Conditions

Interventions

DRUG

Ropivacaine 0.2% Injectable Solution

Single-shot ultrasound-guided erector spine plane block of 0.2% ropivacaine

DRUG

Ropivacaine 0.2% + Dexamethasone

Addiction of 5 mg/ml dexamethasone in 0.2% ropivacaine solution

Sponsors & Collaborators

  • Instituto do Coracao

    lead OTHER_GOV

Principal Investigators

  • Luis Alberto Rodriguez Linares, MD · INCOR FMUSP

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-01-20
Primary Completion
2023-02-25
Completion
2023-04-17

Countries

  • Brazil

Study Locations

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Entities

Diseases

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 NCT04313959 on ClinicalTrials.gov