Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Analgesia, Patient-Controlled
- Nerve Block
- Pain Management
- Pain Postoperative
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia Control: Usual multimodal analgesiaMasking: Triple (Participant, Care Provider, Outcomes Assessor)Masking Description: Participant: The Patients will not know about intervention group they will be. Care Provider : The medical, nursing and pain clinical will not know the group to which the patient belongs Outcomes Assessor: during the analysis the staff will not know which group the patient belongPrimary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
Description
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, seizur...
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
Tracking Information
- NCT #
- NCT03813225
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: luz Pacheco, Esp Fundacion Cardiovascular