Erector Spinae Plane Block
Conditions
Keywords
Spinae erector block, esp block, Analgesia, Continuous analgesia, block
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.
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
DRUGRopivacaine
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).
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.
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.
Sponsors
Instituto do Coracao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
Clinical, double-blinded, randomized, prospective trial
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total morphine consumption | From surgery completion up to postoperative day 5 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Chronic pain scores at 30 days | 30 days after intervention. | Assessment of chronic pain using the Brief Pain Inventory (BPI) scale. |
| Chronic pain scores at 180 days | 180 days after intervention. | Assessment of chronic pain using the Brief Pain Inventory (BPI) scale. |
Countries
Brazil
Contacts
CONTACTJOAO ALBERTO PASTOR de OLIVEIRA, MD
Outcome results
None listed