Pain, Postoperative Clinical Trial
Official title:
Randomized Clinical Trial to Evaluate the Superiority on the Decrease the Consumption of Fentanyl the First 48 Hours of Bilateral Serratus Intercostal Plane Block in Myocardial Revascularization Surgery by Sternotomy.
Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV),
sedation, Hemothorax, seizures, arrythmias
Trial design: Two-parallel arm, double-blind, individually randomized controlled trial.
Primary endpoint:
Fentanyl consumption in the first 48 postoperative hours.
Secondary endpoints:
Pain at rest, Pain on movement, stay in ICU, Postoperative nausea and vomiting (PONV),
sedation, Hemothorax, seizures, arrythmias
Inclusion criteria:
- Patient between 18 years to 80 years.
- Patient to myocardial revascularization by sternotomy
Exclusion criteria:
- Patitient for combined surgery ( myocardial revascularization by sternotomy plus valve
or maze)
- Emergency surgery
- Ejecction Fraction less than 35%
- Allergy to the local anesthesic.
- Allergy to opioids
- Patient in who will be technically impossible the application of the blockade
Trial treatment:
Intervention: These patients will receive the protocol multimodal analgesia patients receive
on the Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg,
Fentanyl Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2
Mcg/k/h during extracorporeal circulation , after extracorporeal circulation the infusion
will be suspended of Fentanyl.In this Arm the patient will give a bilateral serratus
intercostal plane block, will be performed echo-guided puncture in the line anterior axillar
with fifth costal arch, whit 21 ml of anesthetic mass, 20 ml of Levobupivacaine 0.375 and 1
ml (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen
oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Control:
These patients will receive the protocol multimodal analgesia patients receive on the
Colombian Cardiovascular Foundation with Lidocaine 0.5mcg/k. Dexamethasone 8mcg, Fentanyl
Bolus: 7mcg/k . infusion of Fentanyl 4 mcg/k/h start after induction , go down to 2 Mcg/k/h
during extracorporeal circulation , after extracorporeal circulation the infusion will be
suspended of Fentanyl.. and the postoperative analgesia will be 500mg of acetaminophen oral
and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Expected sample size, enrollment and expected number of centers:
Sample size = 44 Recruitment start date: 15 january of 2019 Recruitment end date: 15 July of
2019
Follow-up end date:
Number of centers: 1
Statistical considerations:
- Intention to treat analysis
- The primary outcomes will be analyzed using
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