Bilateral Serratus Intercostal Plane Block for Myocardial Revascularization (SERRINT)

NCT03813225 | Unknown DMC

• 1 other identifier: fcv465
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Pain, Postoperative; Pain Management; Analgesia, Patient-Controlled; Nerve Block

Keywords

Analgesia, patient- controlled, Block , Pain Postoperative

Outcome Measures

Primary Outcomes (1)

• Fentanyl Consume

  Microgrames of Fentanyl that patient consume during the first 48 hours in the postoperative

  48 hours

Secondary Outcomes (6)

• Pain In Rest and in motion

  48 hours

• Nausea and vomiting

  48 hours.

• Sedation

  48 hours.

• hemothorax

  24 hours

• seizures

  1 hour after block

Study Arms (2)

Conventional Analgesia

NO INTERVENTION

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.

Serrato intercostal plane Block

EXPERIMENTAL

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

Other: Bilateral serratus Intercostal plane Block

Interventions

Bilateral serratus Intercostal plane Block OTHER

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.)

Serrato intercostal plane Block

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient between 18 years to 80 years
• Patient to myocardial revascularization by sternotomy

You may not qualify if:

• 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

Sponsors & Collaborators

• Fundación Cardiovascular de Colombia: lead

Study Sites (1)

Luz Jenny Pacheco

Floridablanca, Santander Department, 681004, Colombia

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Bites and Stings

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• luz Pacheco, Esp

  Fundacion Cardiovascular

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luz Pacheco, Esp

CONTACT

57 7 6396767; luzjepal@gmail.com

Anderson Bernmon, MsC

CONTACT

57 7 6399292; andebermon@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intervention: BILATERAL SERRATUS INTERCOSTAL- PLANE BLOCK plus usual multimodal analgesia Control: Usual multimodal analgesia

Study Record Dates

• First Submitted: January 9, 2019
• First Posted: January 23, 2019
• Study Start: January 15, 2019
• Primary Completion: August 30, 2019
• Study Completion: September 30, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)