Pain, Postoperative Clinical Trial
— SERRINTOfficial 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
Status | Recruiting |
Enrollment | 44 |
Est. completion date | September 30, 2019 |
Est. primary completion date | August 30, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patient between 18 years to 80 years - Patient to myocardial revascularization by sternotomy Exclusion Criteria: - Patient for combined surgery ( myocardial revascularization by sternotomy plus valve or maze) - Emergency surgery - Ejection Fraction less than 35% - Allergy to the local anesthesics. - Allergy to opioids - Patient in who will be technically impossible the application of the blockade |
Country | Name | City | State |
---|---|---|---|
Colombia | Luz Jenny Pacheco | Floridablanca | Santander |
Lead Sponsor | Collaborator |
---|---|
Fundación Cardiovascular de Colombia |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Fentanyl Consume | Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative | 48 hours | |
Secondary | Pain In Rest and in motion | It will be valued the pain at rest and in motion, by means of the verbal analog scale for pain, where zero is the absence of pain and 10 is the worst pain that has had on the lives, the pain is measured from the time of extubation what we will call zero hour, and every four hours per 48 hours. | 48 hours | |
Secondary | Nausea and vomiting | Presence of nausea and vomiting during the first 48 hours postoperative. | 48 hours. | |
Secondary | Sedation | Assessment of sedation in the first 48 hours postoperative with the Ramsay scale .The Ramsay scale , Is a subjective scale to assess the degree of sedation of patients, values 6 levels, from 1 where the patient is anxious and agitated ,2 Awake, coperador, focused and quiet. 3. Slept with response to orders. 4. Sleepy with brief answers to the Light. 5 is patient Slept with an answer only to the pain and 6 where the patient is deep asleep without response to stimuli. | 48 hours. | |
Secondary | hemothorax | presence of hemothorax secundary to blockage | 24 hours | |
Secondary | seizures | presence of seizure after to blockage | 1 hour after block | |
Secondary | Arrhythmias | presence of Arrhythmias after of blockage | 1 hour after block |
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