Comparison Erect Spine in Cardiac Surgery

NCT04313959 | Unknown Phase 3

• 1 other identifier: 27166919.3.0000.0068
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Spine Erector; Cardiac Surgery; Acute Pain; Chronic Pain

Keywords

Spine erector; Cardiac surgery; Coronary arterial bypass surgery; Acute Pain; Ropivacaine; Dexamethasone

Outcome Measures

Primary Outcomes (1)

• Pain intensity score

  Changes in Numeric Rating Scale (NRS) and visual analogue scale (VAS) will be recorded daily at postoperative 1 to 7 day or until the patient's hospital discharge if this occurs before 7 days. * Numerical rating scales A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. For example, 0-10 where 0 is no pain and 10 is the worst pain imaginable * VAS have also been utilized in EMA research. VAS are measures of subjective or behavioral experience (e.g., pain, physical exercise). They are typically presented as a 10 cm line with descriptive anchors at each end, such as "completed all prescribed activities today" to "completed none of the prescribed activities today." Respondents place a vertical line through the point on the scale that best fits their experience with that construct at that moment.

  Within 7 days after cardiac surgery

Secondary Outcomes (3)

• Total opioids consumption

  Up to 2 postoperative day

• Pain intensity score

  Up to 90 days

• Duration of mechanical ventilation

  Within 7 days after cardiac surgery

Study Arms (2)

Local anesthetic

ACTIVE COMPARATOR

Patients assigned for local anesthetic group will receive a single-shot ultrasound-guided erector spine plane block with 25 mL of 0.2% of ropivacaine

Drug: Ropivacaine 0.2% Injectable Solution

Local anesthetic + steroid

ACTIVE COMPARATOR

Patients assigned for local anesthetic + steroid group will receive a single-shot ultrasound-guided erector spine block plane with 25 mL of 0.2% of ropivacaine with 5 mg dexamethasone

Drug: Ropivacaine 0.2% Injectable Solution; Drug: Ropivacaine 0.2% + Dexamethasone

Interventions

Ropivacaine 0.2% Injectable Solution DRUG

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

Also known as: Do not have

Local anesthetic; Local anesthetic + steroid

Ropivacaine 0.2% + Dexamethasone DRUG

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

Also known as: Do not have

Local anesthetic + steroid

Eligibility Criteria

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

You may qualify if:

• Coronary artery bypass graft with cardiopulmonary bypass
• Left ventricular ejection fraction ≥ 45%

You may not qualify if:

• Reoperation
• Low cardiac output syndrome
• Preoperative coagulopathy
• Presence of ventricular assist device other than intraaortic ballon pump
• Emergency procedures
• Bacterial or fungal infection in the preceding 30 days
• Active neoplasia
• Allergy or intolerance to steroids
• Allergy to ropivacaine
• Patient refusal
• Participation in other study

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Sites (1)

Incor - Heart Institute - University of Sao Paulo

São Paulo, 05403000, Brazil

RECRUITING

MeSH Terms

Conditions

Acute Pain; Chronic Pain

Interventions

Ropivacaine; Dexamethasone

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Luis Alberto Rodriguez Linares, MD

  INCOR FMUSP

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luis Alberto Rodriguez Linares, MD

CONTACT

+55 11944450729; luis.linares@usp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology at University São Paulo Medical School

Study Record Dates

• First Submitted: March 17, 2020
• First Posted: March 18, 2020
• Study Start: January 20, 2022
• Primary Completion: February 25, 2023
• Study Completion: April 17, 2023
• Last Updated: July 18, 2022

Record last verified: 2022-07

Locations

BR (1)