SERRINT
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.
Sponsor study identifier
interventional
44
1 country
1
Study Start
January 15, 2019
Actual (reported)Primary Completion
August 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 9, 2019
Actual (reported)January 15, 2019
Actual (reported)January 23, 2019
Actual (reported)August 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
September 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Fentanyl Consume
Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
48 hours
Pain In Rest and in motion
48 hours
Nausea and vomiting
48 hours.
Sedation
48 hours.
These patients will receive the protocol multimodal analgesia patients receive on the Colombian Cardiovascular Foundation for handling an analgesic in cardiovascular surgery, this start in surgery 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.
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 mg (2mg) of dexamethasone. and the postoperative analgesia will be 500mg of acetaminophen oral and Analgesia, patient controlled with Fentanyl 20mcg/bolus
Will be performed by echo guided one puncture in the fifth costal arch with anterior axilary line, where the tip of the needle will be guided until it reaches a point above the external intercostal muscle, below the anterior serratus above the costal arch where they will be administered 21 ml of anesthesic mass, (20 ml of levobupivacaine 0.375 and 1 mg (2mg) of dexamethasone.)
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Luz Jenny Pacheco
Floridablanca, Santander Department, 681004, Colombia
luz Pacheco, Esp
Fundacion Cardiovascular
First Submitted
January 9, 2019
First Posted
January 23, 2019
Study Start
January 15, 2019
Actual (reported)Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Adrenalectomy
TQLB for Postoperative Pain After Laparoscopic Partial Nephrectomy
hemothorax
24 hours
seizures
1 hour after block
Contact the study team to confirm eligibility.
Primary Completion
August 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
September 30, 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 22, 2019
Record last verified: 2019-08
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Source: ClinicalTrials.gov.
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