Continuous ESP Block in Patients Undergoing CABG Surgery.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ropivacaine, Standard Postoperative Analgesics, Placebo (0.9% Sodium Chloride).
- Who it may be relevant to
- Registry conditions: Erector Spinae Plane Block. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Brazil
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Continuous Erector Spinea Plane Block in Patients Undergoing Coronary Artery By-pass Graft Surgery.
Overview
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.
Detailed description
All patients who meet the inclusion criteria will be submitted to ESP block after anesthetic induction. This will be performed with fentanyl (up to 5 micrograms/Kg), etomidate (2 milligrams/Kg) and cisatracurium at a dose of two DE95. Then the operator will perform the esp block, at the level of the fourth thoracic vertebra, being blinded as to the content of the solution, if local anesthetic (25 ml of 0.375% Ropivacaine in each side, respecting the toxic dose) or placebo (25 ml of 0.9% NaCl on each side). There will be randomization as to the inclusion in each group, using software. After puncture and infusion of the initial dose, a catheter (Contiplex C,Bbraun) will be inserted on each side, also under ultrasound guidance and connected to a patient-controlled analgesia pump (PCA), with a corresponding solution of ropivacaine or 0.9% NaCl programmed with a maintenance dose a 4ml / Hr and 06ml bolus with trigger. Anesthetic maintenance with halogenated (sevoflurane), cisatracurium in a continuous infusion pump (CIP) of 1-3 micrograms/Kg/min and if necessary remifentanil 0.1-0.3 microgram/Kg/min.
All patients will be submitted to the institution's standard management: multimodal analgesia with common analgesic (dipyrone 4 to 8 g / day or paracetamol 1500 to 2250 mg / day, tramadol 200 to 400 mg / day) in addition to rescue analgesia if necessary. (morphine 02 mg). PCA withdrawal will be on the fifth postoperative day .
Interventions
- Drug Ropivacaine
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). - Drug Standard Postoperative Analgesics
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. - Drug Placebo (0.9% Sodium Chloride)
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.
Primary outcome measures
- Total morphine consumption [Time frame: From surgery completion up to postoperative day 5]
Secondary outcome measures (2)
- Chronic pain scores at 30 days [Time frame: 30 days after intervention.]
- Chronic pain scores at 180 days [Time frame: 180 days after intervention.]
Eligibility criteria
Inclusion criteria
- 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%).
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
Brazil · 1 center
- InCor — São Paulo
Identifiers
NCT: NCT07666178 · 29585120.1.0000.0068