Erector Spina Block or Parasternal Block Plus Chest Tube Wound Infiltration for Cardiac Surgeries

February 12, 2024 updated by: Ayse Ulgey, TC Erciyes University

Comparison of Two Different Techniques for Postoperative Analgesia in Cardiopulmonary Bypass Surgeries: Erector Spinae Plane Block or Parasternal Block Plus Chest Tube Wound Infiltration

Pain management is important after coronary artery bypass graft (CABG) surgery. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. Analgesia with regional methods after surgery provides effective analgesia by reducing morphine consumption. In this study we have planned to compare the erector spina plane block with parasternal block +local infiltration to chest tube areas.

Study Overview

Detailed Description

Patients who will undergo open heart surgery will be included in this study. Pain management is important after coronary artery bypass graft (CABG) surgery. Poorly controlled postoperative pain can trigger myocardial ischemia, increase catecholamine levels, result in increased complications such as stroke and bleeding, and increase the risk of pneumonia. Intravenous morphine is the gold standard for pain relief, but its sedation, cough suppression and decreased bowel movements limit its use. For this reason, regional methods are gaining importance in pain treatment. After cardiac surgery. Both sternotomy and bilateral chest tubes are the most painful interventions during cardiac surgeries. Parasternal block can be a good alternative in the treatment of pain in CABG surgeries. In parasternal application, the aim is to anesthetize the nerves innervating the sternum between the pectoral muscle and the intercostal muscle by holding the probe in the parasagittal plane on the lateral side of the sternum under USG guidance. Patients who will undergo open heart surgery will be included in this study. The patients will be divided into two groups, and in Group 1, before general anesthesia is given, bilateral ESPB will be performed at the 4-6th thoracic level in the prone position, and then routine general anesthesia will be performed (at this stage, the patients will be given sedation to prevent them from feeling pain). After endotracheal intubation, in Group 2, a parasternal block will be performed from the lateral sternum. At the end of the surgery, local anesthetic infiltration will be perform to the tube sites. General anesthesia and surgical procedures will be performed routinely in both groups. In the intensive care unit patients will be monitored for pain levels, intubation duration, whether there is atelectasis in the lungs, and the need for reintubation. Pain assessment will be evaluated with the behavioral pain score while the patients are intubated and with the visual pain scale after extubation. Whether atelectasis has developed will be evaluated with ultrasonography at the 12th and 24th hours postoperatively

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

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:

  1. Patients who will undergo open heart surgery
  2. Patients who agreed to participate in the study-

Exclusion Criteria:

  1. Patients who do not agree to participate in the study
  2. Patients with chronic lung disease
  3. Patients with D. Mellitus

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1
in this group erector spina plane block will be performed before surgery for post operative analgesia

Group 1: erector spina plane block: With USG guidance at the thoracal level of 4-5, with 20ml 2.5% bupivacaine ESPB will be performed. after surgery in the ICU pain score and atelectasia will be evaluated.

Group 2: With USG guidance parasternal block will be performed after intubation bilaterally with 10 ml 0.25% bupivacaine each side. at the end of the surgery infiltration of chest tube sides will be performed with 10 ml 2.5% bupivacain.

Active Comparator: Group 2
in this group after endotracheal intubation bilateral parasternal block will be performed and to the chest tube sides local anesthetic infiltration will be performed

Group 1: erector spina plane block: With USG guidance at the thoracal level of 4-5, with 20ml 2.5% bupivacaine ESPB will be performed. after surgery in the ICU pain score and atelectasia will be evaluated.

Group 2: With USG guidance parasternal block will be performed after intubation bilaterally with 10 ml 0.25% bupivacaine each side. at the end of the surgery infiltration of chest tube sides will be performed with 10 ml 2.5% bupivacain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative analgesia
Time Frame: 24 hours after after surgery
postoperatively in the intensive care unit during mechanical ventilation behavioral pain, score, after extubation visüel analog scala will be used to measure postoperative pain of the patients. during mechanical ventilation every 2 hours after extübation 2., 4., 6., 8., 12., 24. hours
24 hours after after surgery
postoperative atelectasia
Time Frame: 24 hours after after surgery
postoperatively at the 12. th and 24.th hours with ultrasonography the patients lungs will be sreened for atelectasis
24 hours after after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
postoperative mechanical ventilation duration
Time Frame: 24 hours after after surgery
in the intensive care unit time to endotracheal extubation will be recorded
24 hours after after surgery

Collaborators and Investigators

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

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 (Estimated)

March 1, 2024

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

August 1, 2024

Study Registration Dates

First Submitted

December 25, 2023

First Submitted That Met QC Criteria

February 12, 2024

First Posted (Actual)

February 20, 2024

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 12, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 2023/337

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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