Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-01

Study Completion Date

2025-08-01

Brief Summary

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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.

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Detailed Description

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The study will proceed in three arms. The first group is the control group and will receive total intravenous anaesthesia as infusion after peroperative induction until the patient leaves the operating room. The second group will receive ultrasound-guided parasternal superficial plan block after induction. The third group will receive ultrasound-guided parasternal deep plan block. Extubation times, additional analgesic needs, pain scores, intensive care unit duration and hospital discharge times will be compared in the three groups during intensive care unit follow-up. After extubation, patient-controlled analgesia will be applied for 24 hours (with pca infusion pump device).

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

randomized controlled

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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1. control group

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

Group Type ACTIVE_COMPARATOR

1. no block

Intervention Type 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.

2. superficial parasternal plane block group

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.

Group Type ACTIVE_COMPARATOR

2. superficial parasternal block

Intervention Type 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.

3. deep parasternal plane block group

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.

Group Type ACTIVE_COMPARATOR

3. deep parasternal block

Intervention Type 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.

Interventions

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1. no 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.

Intervention Type PROCEDURE

2. superficial parasternal block

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.

Intervention Type PROCEDURE

3. deep parasternal block

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.

Intervention Type PROCEDURE

Other Intervention Names

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intravenous analgesia intravenous analgesia regional analjesia intravenous analgesia regional analjesia

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No