Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy

April 24, 2024 updated by: münire deniz, Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Efficacy of Parasternal Blocks in Cardiovascular Surgery Patients Undergoing Median Sternotomy: Randomized, Controlled Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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.
Procedure: 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.
Other Names:
  • intravenous analgesia
Active Comparator: 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.
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.
Other Names:
  • intravenous analgesia
  • regional analjesia
Active Comparator: 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.
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.
Other Names:
  • intravenous analgesia
  • regional analjesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative chronic pain
Time Frame: 6 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative 24 hours acute pain
Time Frame: 24 hours
postoperative 24 hours pain of the patients will be evaluated with VAS (visual analogue scale). analgesic needs of the patients in the first 24 hours postoperatively will be calculated as morphine equivalent dose using PCA device. At the end of the 24th hour, BPI (brief pain index) will be evaluated. additional analgesic needs of the patients (NSAID, narcotic), if any, will be recorded. it will be evaluated whether there is a significant difference between the VAS scores, analgesic needs and BPI scores in the first 24 hours pain according to the groups.
24 hours
extubation time
Time Frame: 24 hours
Extubation time (defined as the time from admission to intensive care unit until extubation) will be evaluated for differences between the groups.the control group
24 hours
icu time
Time Frame: 7 days
The study will look at whether intensive care and hospital discharge times differ between the groups.
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kartal Kosuyolu Yuksek Ihtisas Education and Research Hospital

Investigators

  • Study Director: munire deniz, kosuyolu high education and training center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Actual)

April 16, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

April 4, 2024

First Submitted That Met QC Criteria

April 24, 2024

First Posted (Actual)

April 26, 2024

Study Record Updates

Last Update Posted (Actual)

April 26, 2024

Last Update Submitted That Met QC Criteria

April 24, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/01/756

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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