Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy

NCT06387095 | Recruiting

• 1 other identifier: 2024/01/756
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

Acute and chronic pain after cardiac surgery is a common problem that negatively affects quality of life. Postoperative pain after cardiac surgery is most intense in the first two days and decreases in the following period. However, postoperative pain with incomplete management in the acute period may become chronic. This may negatively affect the patient's quality of life. Although central blocks such as thoracic epidural and paravertebral blocks are considered the gold standard in analgesia control, the advantages of thoracic plan blocks, which are more superficial due to peroperative heparinisation; coagulation disorders; and procedural difficulties, are undeniable. Thoracic plane blocks, which can also be used in patients receiving anticoagulant and/or antiplatelet therapy, have recently been used for acute pain. The aim of this study was to evaluate the effect of thoracic plane blocks on extubation time, pain scores, intensive care unit (ICU) and hospital stays in patients undergoing median sternotomy.

Conditions

Postoperative Pain

Keywords

postoperative pain; parasternal blocks; chronic pain; acute pain; cabg

Outcome Measures

Primary Outcomes (1)

• postoperative chronic pain

  Determination the effect of parasternal blocks on the incidence for chronic pain at 6 months postoperative period in cardiac surgery. The s-lanss scores of the patients at the 6th postoperative month will be evaluated. The range of the questionnaire is 0-24 and patients with a score above 12 will be considered to have neuropathic pain.

  6 months

Secondary Outcomes (3)

• postoperative 24 hours acute pain

  24 hours

• extubation time

  24 hours

• icu time

  7 days

Study Arms (3)

1. control group

ACTIVE COMPARATOR

control group. block will not be applied to this group and the patient's analgesia needs will be provided with patient-controlled analgesia devices.

Procedure: 1. no block

2. superficial parasternal plane block group

ACTIVE COMPARATOR

superficial parasternal plane block group. superficial paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs.

Procedure: 2. superficial parasternal block

3. deep parasternal plane block group

ACTIVE COMPARATOR

deep parasternal plane block group. deep paraasternal plane block will be applied to this group. it will be applied to the parasternal region with ultrasound after the patient is intubated. patient-controlled analgesia devices will be used for additional postoperative pain needs.

Procedure: 3. deep parasternal block

Interventions

1. no block PROCEDURE

After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.

Also known as: intravenous analgesia

1. control group

2. superficial parasternal block PROCEDURE

After induction, the patient will undergo an ultrasound-guided superficial parasternal plan block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.

Also known as: intravenous analgesia, regional analjesia

2. superficial parasternal plane block group

3. deep parasternal block PROCEDURE

After induction, the patient will undergo an ultrasound-guided deep parasternal plane block. . After extubation, patient-controlled analgesia will be applied for 24 hours (with PCA infusion pump device). During the follow-up of the patients in intensive care, extubation times, additional analgesic needs, pain scores; intensive care and hospital discharge times will be recorded.

Also known as: intravenous analgesia, regional analjesia

3. deep parasternal plane block group

Eligibility Criteria

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

You may qualify if:

• Performing median sternotomy
• Elective case
• Over 18 years of age; under 80 years of age
• ASA II-III patients

You may not qualify if:

• Emergency cases
• Patients undergoing minimally invasive surgery
• Patients with a history of opioid use in the last 30 days
• Redo cases
• Patients with left ventricular ejection fraction less than 30%
• Patients with severe hepatic or renal insufficiency
• Patients with chronic pain before surgery (migraine, fibromyalgia)

Sponsors & Collaborators

• Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital: lead

Study Sites (1)

Kosuyolu High Education and Training Hospital

Istanbul, Kartal, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Chronic Pain; Acute Pain

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• munire deniz

  kosuyolu high education and training center

  STUDY DIRECTOR

Central Study Contacts

omer savluk

CONTACT

+905056877440; dromersavluk@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Medical Doctor

Model Details: randomized controlled

Study Record Dates

• First Submitted: April 4, 2024
• First Posted: April 26, 2024
• Study Start: February 1, 2024
• Primary Completion: April 16, 2024
• Study Completion: August 1, 2025
• Last Updated: April 26, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)