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Comparison of Interpectoral+Serratus Anterior Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery

Primary Purpose

Postoperative Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
interpectoral area block + serratus anterior area block group
Sponsored by
Namik Kemal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring pain management, regional anesthesia, minimally invasive cardiac surgery

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Patients who will undergo cardiac surgery for the first time ASA I-II (American Society of Anesthesiology classification) patients between the ages of 18-75 Patients with an average bleeding profile Patients who gave written consent to participate in the study Patients without local anesthetic allergy and a history Patients who have the intellectual level to use the patient-controlled analgesia device Exclusion Criteria: Patients who have undergone open heart surgery before undergoing valve replacement and revision Patients who did not agree to participate in the study Patients with cancer primarily Patients with local anesthetic allergy and a history Patients who do not have the intellectual level to use a patient-controlled analgesia device Patients with abnormal bleeding profile Patients who were re-operated due to any surgical complication (bleeding, etc.) within the 24th hour after the operation

Sites / Locations

  • Namık Kemal UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

interpectoral area block + serratus anterior area block group (IPSA)

erector spinae group (ES)

Arm Description

Interpectoral plane block + serratus anterior plane block will be performed randomly on the participants.

Erector spinae block will be performed randomly on the participants

Outcomes

Primary Outcome Measures

Paa pain Scores (NRS)
A numerical ratio scale (NRS) requires the patient to rate pain on a defined scale. ifor example,0-10 where 0 is no pain and 10 is the worst pain imaginable.

Secondary Outcome Measures

opioid consumption
Patient-controlled analgesia (PCA) is a method of pain control that gives patients the power to control their pain. In PCA, a computerized pump called the patient-controlled analgesia pump, which contains a syringe of pain medication as prescribed by a doctor, is connected directly to a patient's intravenous (IV) line. (micrograms)
recovery criteria
Postoperative recovery is an energy-requiring process that has four dimensions - physiological, psychological, social, and habitual recovery. The meaning after minimally invasive cardiac surgery; covers the parameters followed by the patient in the intensive care process and in the clinic. extubation time (from the moment of arrival in the intensive care unit/hr. Postoperative carbon dioxide levels in mmHg.Drainage amount in milliliters.
intraoperative
As it is known, single-lung ventilation is performed in these patients until they enter the heart-lung pump. In the meantime, it is essential to determine whether there are changes in the NIRS( near-infrared spectroscopy monitor) values compared to the baseline in these cases.(%)
CPOT score until extubation
Critical Care Pain Observation Tool (CPOT)The CPOT was developed for the assessment of pain in critically ill patients. The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients.(0 to 8)

Full Information

First Posted
January 13, 2023
Last Updated
February 21, 2023
Sponsor
Namik Kemal University
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1. Study Identification

Unique Protocol Identification Number
NCT05743231
Brief Title
Comparison of Interpectoral+Serratus Anterior Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery
Official Title
Comparison of Interpectoral Area Block+Serratus Anterior Area Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery, Effect on Postoperative Pain and Recovery; Randomized Clinical Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 29, 2022 (Actual)
Primary Completion Date
August 15, 2023 (Anticipated)
Study Completion Date
August 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Namik Kemal University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Adequate pain management after minimally invasive cardiac surgery is essential for early ambulation and patient satisfaction. However, an incision similar to thoracotomy surgery is made by entering between the ribs, and a severely painful postoperative period is experienced as the intercostal nerves are cut. Invasive cardiac surgery is necessary surgery that can take steps to improve the quality of life and functional status of patients without sternotomy. However, patients may experience intense pain in the immediate postoperative period, which can lead to inactivity, increased risk of complications, and greater consumption of opioids, resulting in adverse effects and prolonged hospital stays. Pain management is challenging due to a large number of dermatomes covered. Interpectoral plane block + serratus anterior plane block, defined in 2012, has been used in many studies before as part of multimodal analgesia in minimally invasive cardiac surgery. Erector spinae block was also described in 2018 with positive results, which has been used in both sternotomies (open heart surgery) and minimally invasive procedures. Minimally invasive cardiac surgery can be excruciating in the postoperative period, just like thoracotomy surgeries. What is aimed in this study is to compare two previously known regional anesthesia techniques in this study.
Detailed Description
Minimally invasive cardiac surgery is necessary surgery that can take steps to improve the quality of life and functional status of patients without sternotomy. However, patients may experience intense pain in the immediate postoperative period, which can lead to inactivity, increased risk of complications, and greater consumption of opioids, resulting in adverse effects and prolonged hospital stays. Pain management is challenging due to a large number of dermatomes covered. The interpectoral plane block + serratus anterior plane block seems to cover the thoracic dermatomes. It has been the subject of many studies in the same surgical group. Minimally invasive cardiac surgery can be excruciating in the postoperative period, just like thoracotomy surgeries. What is aimed of this study is to compare it with erector spinae block in this study. Additional anesthetic techniques, such as peripheral nerve blocks, are part of the multimodal analgesic strategy and are often used to manage acute pain better. Inadequate treatment can lead to persistent pain conditions. Although numerous nerve blocks exist for this purpose, some may fail because they do not cover the thoracic dermatomes or their entire innervation. The central hypothesis of this study hypothesis, interpectoral plane block + serratus anterior plane block, defined in 2012, has been used in many previous studies as part of multimodal analgesia in minimally invasive cardiac surgery. Erector spinae block was also described in 2018 with positive results that have been used in both sternotomies (open heart surgery) and minimally invasive procedures. In this randomized clinical trial, the study aims to compare the efficacy of previously known field blocks as part of multimodal analgesia in minimally invasive cardiac surgery. As presented in the literature, these techniques have been routinely performed so much that review articles have been written. Targeted in this study, preliminary results will be postoperative pain scores. At Namık Kemal University anesthesia clinic, It is regularly used as part of multimodal analgesia and resident training. Traditional intravenous analgesia methods cause many undesirable side effects depending on the type of opioid used, and they are insufficient compared to regional anesthesia methods. The main aim of this study is to investigate the effectiveness of these two methods, routinely used in thoracic surgery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
pain management, regional anesthesia, minimally invasive cardiac surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
Participants will be randomly divided into two groups. The physician who will collect data in the cardiac surgery intensive care unit and cardiac surgery clinic will not know which group the participant is in.
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
interpectoral area block + serratus anterior area block group (IPSA)
Arm Type
Active Comparator
Arm Description
Interpectoral plane block + serratus anterior plane block will be performed randomly on the participants.
Arm Title
erector spinae group (ES)
Arm Type
Active Comparator
Arm Description
Erector spinae block will be performed randomly on the participants
Intervention Type
Procedure
Intervention Name(s)
interpectoral area block + serratus anterior area block group
Other Intervention Name(s)
IPSA
Intervention Description
The interpectoral and serratus anterior area blocks will be applied immediately after general anesthesia is given to the participants under ultrasound guidance. 30 ml of 0.25% bupivacaine will be used for two blocks.
Primary Outcome Measure Information:
Title
Paa pain Scores (NRS)
Description
A numerical ratio scale (NRS) requires the patient to rate pain on a defined scale. ifor example,0-10 where 0 is no pain and 10 is the worst pain imaginable.
Time Frame
up to 48 hours.
Secondary Outcome Measure Information:
Title
opioid consumption
Description
Patient-controlled analgesia (PCA) is a method of pain control that gives patients the power to control their pain. In PCA, a computerized pump called the patient-controlled analgesia pump, which contains a syringe of pain medication as prescribed by a doctor, is connected directly to a patient's intravenous (IV) line. (micrograms)
Time Frame
up to 48 hours
Title
recovery criteria
Description
Postoperative recovery is an energy-requiring process that has four dimensions - physiological, psychological, social, and habitual recovery. The meaning after minimally invasive cardiac surgery; covers the parameters followed by the patient in the intensive care process and in the clinic. extubation time (from the moment of arrival in the intensive care unit/hr. Postoperative carbon dioxide levels in mmHg.Drainage amount in milliliters.
Time Frame
up to 48 hours
Title
intraoperative
Description
As it is known, single-lung ventilation is performed in these patients until they enter the heart-lung pump. In the meantime, it is essential to determine whether there are changes in the NIRS( near-infrared spectroscopy monitor) values compared to the baseline in these cases.(%)
Time Frame
up to 48 hours
Title
CPOT score until extubation
Description
Critical Care Pain Observation Tool (CPOT)The CPOT was developed for the assessment of pain in critically ill patients. The scale consists of four behavioral domains: facial expression, body movements, muscle tension and compliance with the ventilation for intubated patients.(0 to 8)
Time Frame
up to extubation time.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who will undergo cardiac surgery for the first time ASA I-II (American Society of Anesthesiology classification) patients between the ages of 18-75 Patients with an average bleeding profile Patients who gave written consent to participate in the study Patients without local anesthetic allergy and a history Patients who have the intellectual level to use the patient-controlled analgesia device Exclusion Criteria: Patients who have undergone open heart surgery before undergoing valve replacement and revision Patients who did not agree to participate in the study Patients with cancer primarily Patients with local anesthetic allergy and a history Patients who do not have the intellectual level to use a patient-controlled analgesia device Patients with abnormal bleeding profile Patients who were re-operated due to any surgical complication (bleeding, etc.) within the 24th hour after the operation
Facility Information:
Facility Name
Namık Kemal University
City
Tekirdağ
State/Province
Süleymanpaşa
ZIP/Postal Code
59100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayhan Şahin, 1
Phone
0905324730503
Email
aysahin@nku.edu.tr
First Name & Middle Initial & Last Name & Degree
Onur Baran, 2
Phone
0905393422582
Email
dronurbaran@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Comparison of Interpectoral+Serratus Anterior Block With Erector Spinae Block in Minimally Invasive Cardiac Surgery

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