Continuous ESP Block in Patients Undergoing CABG Surgery.

NCT07666178 | Recruiting Phase 3

• 1 other identifier: 29585120.1.0000.0068
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This study addresses articles and studies related to the erector spinae plane (ESP) block and its technique, advantages and disadvantages, applicability, among others. It aims to provide more information about this block, which is relatively new, and how it can be explored in the anesthesiologist's routine, mainly inserted in the anesthesia scenario for cardiac surgery with a focus on postoperative analgesia.

Conditions

Erector Spinae Plane Block

Keywords

Spinae erector block; esp block; Analgesia; Continuous analgesia; block

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Total cumulative consumption of morphine (measured in milligrams) recorded in the electronic medical record. All routes of administration (intravenous, patient-controlled analgesia pump, or oral) will be converted to intravenous morphine equivalents

  From surgery completion up to postoperative day 5

Secondary Outcomes (2)

• Chronic pain scores at 30 days

  30 days after intervention.

• Chronic pain scores at 180 days

  180 days after intervention.

Study Arms (2)

ESP Block Ropivacaine PCA group

ACTIVE COMPARATOR

Local anesthetic solution group that received the solution with the local anesthetic in the ESP block and also in the patient-controlled analgesia pump. Perform the esp block, at the level of the fourth thoracic vertebra, administration of local anesthetic (25 ml of 0.25% ropivacaine in each side, respecting the toxic dose).After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding bupivacaine solution programmed with a maintenance dose of 4ml / Hr and bolus of 06 ml with the trigger firing.

Drug: Ropivacaine; Drug: Standard Postoperative Analgesics

ESP Block placebo PCA group

PLACEBO COMPARATOR

Group that will serve as a comparison for blockade with analgesia. That is, this group had received a placebo solution. Perform the esp block, at the level of the fourth thoracic vertebra, and the content of the solution will be placebo (25 ml of saline / 0.9% NaCl on each side). After puncture and infusion of the initial dose, a catheter will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with 0.9% NaCl solution programmed with a maintenance dose at 4ml / Hr and 06 ml bolus with trigger.

Drug: Standard Postoperative Analgesics; Drug: Placebo (0.9% Sodium Chloride)

Interventions

Ropivacaine DRUG

Bilateral Erector Spinae Plane (ESP) block performed at the T4 level using 25 mL of 0.25% ropivacaine per side, followed by continuous postoperative patient-controlled regional analgesia (PCA) pump programmed with ropivacaine (maintenance rate of 4 mL/h, demand bolus of 6 mL).

ESP Block Ropivacaine PCA group

Standard Postoperative Analgesics DRUG

Systemic multimodal analgesic regimen based on institutional protocols, consisting of scheduled and rescue oral and intravenous (IV) analgesics (such as dipyrone, NSAIDs, or opioids) as part of usual postoperative care.

ESP Block Ropivacaine PCA group; ESP Block placebo PCA group

Placebo (0.9% Sodium Chloride) DRUG

Inactive saline solution (25 mL of 0.9% NaCl per side) administered during a sham bilateral ESP block at the T4 level, followed by a continuous postoperative PCA pump infusion of 0.9% NaCl (maintenance rate of 4 mL/h, demand bolus of 6 mL) to serve as a comparator.

ESP Block placebo PCA group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Consent to the free and informed consent term.
• Patient undergoing coronary artery bypass graft surgery with cardiopulmonary bypass (CPB).
• Preserved left ventricular global function (LVEF \> 50%).

You may not qualify if:

• Moderate or severe valvular dysfunction.
• Previous anterior sternotomy.
• Known allergy to the study drugs.
• Complications during catheter insertion or block placement.
• Pre-existing diagnosed chronic pain under treatment.
• Concomitant use of drugs with a long half-life (induction and anesthetic maintenance doses will be standardized; patients taking medications with a long half-life are excluded to prevent bias in outcome assessment).
• Concomitant administration of Magnesium Sulfate.

Sponsors & Collaborators

• Instituto do Coracao: lead

Study Sites (1)

InCor

São Paulo, São Paulo, Brazil

RECRUITING

MeSH Terms

Conditions

Agnosia; Bites and Stings

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

JOAO ALBERTO PASTOR de OLIVEIRA, MD

CONTACT

+5511991700431; joaoalbertopastor@yahoo.com.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The blinding of the intervention for patients, anesthesiologists, cardiac surgeons, intensivists, nurses, outcome assessors and investigators will be guaranteed by a central randomization, the preparation and solution of the protocol will be carried out by the study's non-blind team, randomization will be 1: 1. There will be randomization as to the inclusion in each group, using software.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Anesthesiology at University São Paulo Medical School

Model Details: Clinical, double-blinded, randomized, prospective trial

Study Record Dates

• First Submitted: September 26, 2022
• First Posted: June 24, 2026
• Study Start: December 12, 2024
• Primary Completion (Estimated): December 12, 2027
• Study Completion (Estimated): December 12, 2027
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)