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Continuous ESP Block in Patients Undergoing CABG Surgery.

ConditionErector Spinae Plane Block
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorInstituto do Coracao

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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%).

Disqualifiers

Moderate or severe valvular dysfunction.

Previous anterior sternotomy.

Known allergy to the study drugs.

Complications during catheter insertion or block placement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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).

  • 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.

  • 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.

Treatment groups

78 Participants
are divided into 2 treatment groups
Group A: ESP Block Ropivacaine PCA groupActive comparator 2 interventions
Group B: ESP Block placebo PCA groupPlacebo comparator 2 interventions

Trial outcomes

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

Time frame
From surgery completion up to postoperative day 5

Secondary outcomes

1

Chronic pain scores at 30 days

Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.

Time frame
30 days after intervention.
2

Chronic pain scores at 180 days

Assessment of chronic pain using the Brief Pain Inventory (BPI) scale.

Time frame
180 days after intervention.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Instituto do Coracao

Lead sponsor

Source ClinicalTrials.gov
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