Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT) (SERRINT)
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| ClinicalTrials.gov Identifier: NCT03813225 |
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Recruitment Status : Unknown
Verified August 2019 by Fundación Cardiovascular de Colombia.
Recruitment status was: Recruiting
First Posted : January 23, 2019
Last Update Posted : August 22, 2019
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Pain, Postoperative Pain Management Analgesia, Patient-Controlled Nerve Block | Other: Bilateral serratus Intercostal plane Block | Not Applicable |
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| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 44 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia Control: Usual multimodal analgesia |
| Masking: | 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 belong |
| Primary Purpose: | Supportive Care |
| 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. |
| Actual Study Start Date : | January 15, 2019 |
| Estimated Primary Completion Date : | August 30, 2019 |
| Estimated Study Completion Date : | September 30, 2019 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Conventional Analgesia
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. |
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Experimental: Serrato intercostal plane Block
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
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Other: Bilateral serratus Intercostal plane Block
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.) |
- Fentanyl Consume [ Time Frame: 48 hours ]Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative
- Pain In Rest and in motion [ Time Frame: 48 hours ]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.
- Nausea and vomiting [ Time Frame: 48 hours. ]Presence of nausea and vomiting during the first 48 hours postoperative.
- Sedation [ Time Frame: 48 hours. ]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.
- hemothorax [ Time Frame: 24 hours ]presence of hemothorax secundary to blockage
- seizures [ Time Frame: 1 hour after block ]presence of seizure after to blockage
- Arrhythmias [ Time Frame: 1 hour after block ]presence of Arrhythmias after of blockage
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| Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03813225
| Contact: Luz Pacheco, Esp | 57 7 6396767 ext 411 | luzjepal@gmail.com | |
| Contact: Anderson Bernmon, MsC | 57 7 6399292 | andebermon@gmail.com |
| Colombia | |
| Luz Jenny Pacheco | Recruiting |
| Floridablanca, Santander, Colombia, 681004 | |
| Contact: luz Pacheco, Esp 57 7 6396767 ext 411 luzjepal@gmail.com | |
| Principal Investigator: | luz Pacheco, Esp | Fundacion Cardiovascular |
| Responsible Party: | Fundación Cardiovascular de Colombia |
| ClinicalTrials.gov Identifier: | NCT03813225 |
| Other Study ID Numbers: |
fcv465 |
| First Posted: | January 23, 2019 Key Record Dates |
| Last Update Posted: | August 22, 2019 |
| Last Verified: | August 2019 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Analgesia, patient- controlled, Block , Pain Postoperative |
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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations |