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Serratus Anterior Plan Block and Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery

Primary Purpose

Morphine Consumption, Pain

Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
SAPB (Serratus Anterior Plan) Block
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Morphine Consumption focused on measuring Serratus anterior plan block, Postoperative Pain, Minimally Invasive Cardiac Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Between the ages of 18-65, Coronary artery patients with normal left ventricular function and scheduled for elective coronary artery bypass surgery, Valve diseases for which elective valve replacement is planned with normal left ventricular function, Cases of ASD (Atrial Septal Defect) for atrial septal defect closure Patients who will have elective valve + coronary artery bypass without left ventricular dysfunction and patients who volunteer to participate in the study, No coagulation disorder Patients with a platelet count of more than 100,000, Patients with good mental status, Patients with an ejection difference value (E/F) above 50% will be included in the study. Exclusion Criteria: Cases that will require emergency and repeat heart surgery, With advanced left coronary artery disease and left ventricular dysfunction, Receiving preoperative inotropic support therapy for any reason, Mitral stenosis with atrial thrombus, Patients with low cardiac out put syndrome and E/F below 50%, Patients who need intra-aortic balloon pump during surgery, Patients with bleeding and coagulation disorders, Patients with hepatic and renal dysfunction, Patients with Uncontrolled Diabetes Mellitus and Chronic Obstructive Pulmonary Disease, Patients allergic to opioids, analgesics and bupivacaine, Patients with atrial fibrillation using anticoagulants, Patients with cognitive dysfunction Patients who do not want to participate in the study will be excluded from the study.

Sites / Locations

  • Kahramanmaras Sutcu Imam University Faculty of MedicineRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group SAPB (Serratus anterior plane block)

Group Control

Arm Description

Active Comparator: Group SAPB (Serratus anterior plane block) After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. The latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs using a 22-gauge, 80 mm insulated Quincke type needle with the 'in plane' technique, accompanied by a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath. . After the fascia between the two muscles is fixed, the block needle will be advanced from caudal to cranial and 40 ml (20 ml local anesthetic + 20 ml saline) 0.25% local anesthetic will be injected on the serratus muscle between the two muscles.

The action will not be applied

Outcomes

Primary Outcome Measures

Morphine consumption by PCA (Patient Control Analgesia)
Morphine consumption used in case of pain

Secondary Outcome Measures

pain (NRS)score
Change from baseline NRS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be
PH
PH change after extubation
PO2
PO2 change after extubation
Mean Arterial Pressure (MAP)
MAP change after extubation
PCO2
PCO2 change after extubation

Full Information

First Posted
May 31, 2023
Last Updated
October 20, 2023
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT06002867
Brief Title
Serratus Anterior Plan Block and Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery
Official Title
Investigation of the Effect of Serratus Anterior Plan Block on Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
March 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kahramanmaras Sutcu Imam University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Acute postoperative pain is defined as sudden onset pain that develops after stimulation due to surgical intervention. It is most severe in the first 24 hours after surgery and gradually decreases in severity and creates dissatisfaction in the patient. Postoperative pain that cannot be treated properly can cause various systemic effects, prolongation of hospital stay, decrease in patients' quality of life, and development of chronic pain. An increase in blood pressure, heart rate, cardiac irritability and systemic vascular resistance is observed with the sympathetic response due to pain. Increased myocardial workload and oxygen consumption may increase or trigger myocardial ischemia. Pulmonary dysfunction has an important place in the determination of mortality and morbidity after surgery and anesthesia.Especially in patients who have undergone thoracic surgery, pain limits the movements of the thoracic muscles, reducing functional residual capacity and vital capacity.This causes the development of atelectasis in the patient and the development of hypoxia and pneumonia due to the deterioration of the ventilation/perfusion ratio. Effective analgesia can be achieved in the postoperative period by administering a certain volume of local anesthetic between any two muscle planes using USG. In SAPB, a local anesthetic is injected between the serratus anterior muscle and the latissimus dorsi muscle to create sensory paresthesia in the thoracic wall. It is known to reduce pain scores in the postoperative period. Serratus anterior plane block is a safe facial plane block performed under USG guidance.Depending on the application site of the block and the amount of local anesthetic administered, different numbers of intercostal nerves, long thoracic nerves and thoracodorsal nerves may be affected. The fact that Serratus anterior plane block (SAPB) is effective between T2-T9 dermatomes enables it to be used effectively in lateral thoracic wall surgeries.
Detailed Description
Patients between the ages of 18-65 who will undergo minimally invasive cardiac surgery under elective conditions will be included in the study. Patients will be randomized. The patients will be included in the study after they are informed about the study and their consent is obtained with the patient consent form. Patient groups will be divided into two groups as SAPB Group (n=20) and Control Group (n=20). All patients will be intubated with a double lumen endotracheal intubation tube in accordance with general anesthesia rules. Patients' age, weight, height, body mass index (BMI), additional disease, surgery, medications used, Ejection/Fraction, platelet count (x10/L), cardiopulmonary bypass time (min), aortic cross clamp time (min) , intraoperative remifentanil amount (mcq), intraoperative morphine dose (0.1 mg/kg), postoperative extubation time (min), post extubation, 1. hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour NRS (Numerical Rating Scale) pain score (between 0 and 10, no pain at 0, maximum pain at 10), extubation after, 1st hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour morphine consumption (Patient Controlled Analgesia), how many additional doses paracetamol was administered, how many additional doses were administered, additional analgesic need time (minutes), postoperative hemodynamic monitoring, 1st hour, 2nd hour, 4th hour, 8th hour, 12th hour, 24th hour PH, PO2 (oxygen pressure) ), MAP (mean arterial pressure), will be recorded. In addition, nausea, vomiting, itching, constipation, and the duration of intensive care hospitalization will also be recorded in the postoperative period. The patient will be told to express the degree of postoperative pain using the numerical scoring scale (NRS) before the operation. The patient will be informed about the PCA to be inserted in the postoperative period. After the surgical procedure is completed, serratus anterior plane block will be applied to the patients under the guidance of postoperative USG. After the surgery, the patients will be transferred to the cardiovascular surgery intensive care unit. Serratus Anterior Plan (SAP) Block: After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. With a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath, using the 'in plane' technique using a 22-gauge, 80 mm insulated Quincke type needle, midaxillary line with the latissimus dorsi muscle and serratus at the level of the 4th and 5th ribs. After determining the fascia between the two muscles by imaging the muscle, the block needle will be advanced from caudal to cranial and 40 ml of 0.25% bupivacaine will be injected on the serratus muscle between the two muscles. No block will be applied to the control group. Only the PCA (Patient Control Analgesia) drug with Morphine will be used. In the intensive care unit, the patients will be extubated after respiratory effort appears, when the patient is awake, blood gas values are within the normal range, body temperature is normal, and hemodynamically stable. When NRS is >3-4, patients will be instructed to press the PCA device. If the patient's consciousness and hemodynamic status do not allow for pain assessment, the patient will be excluded from the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morphine Consumption, Pain
Keywords
Serratus anterior plan block, Postoperative Pain, Minimally Invasive Cardiac Surgery

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Grup SAPB Grup Control
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group SAPB (Serratus anterior plane block)
Arm Type
Active Comparator
Arm Description
Active Comparator: Group SAPB (Serratus anterior plane block) After the operation is completed, the block operation will be performed while intubated. The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. The latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs using a 22-gauge, 80 mm insulated Quincke type needle with the 'in plane' technique, accompanied by a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath. . After the fascia between the two muscles is fixed, the block needle will be advanced from caudal to cranial and 40 ml (20 ml local anesthetic + 20 ml saline) 0.25% local anesthetic will be injected on the serratus muscle between the two muscles.
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
The action will not be applied
Intervention Type
Procedure
Intervention Name(s)
SAPB (Serratus Anterior Plan) Block
Intervention Description
The patient will be in the supine position. The area where the procedure will be performed will be cleaned with povidone iodine. Using a 22-gauge, 80 mm insulated Quincke needle with a high frequency (10-18 MHz) ultrasound linear probe covered with a sterile sheath, the latissimus dorsi muscle and the serratus muscle will be visualized at the level of the 4th and 5th ribs. After determining the fascia between the two muscles, the block needle will be advanced from caudal to cranial and 40 ml of 0.25% bupivacaine (local anesthetic) will be injected on the serratus muscle between the two muscles.
Primary Outcome Measure Information:
Title
Morphine consumption by PCA (Patient Control Analgesia)
Description
Morphine consumption used in case of pain
Time Frame
The change from baseline in the postoperative period at the 1, 2, 4, 8, 12 and 24th hour after extubation
Secondary Outcome Measure Information:
Title
pain (NRS)score
Description
Change from baseline NRS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be
Time Frame
Change from baseline of NRS Score at 1,2, 4,,8, 12 and 24 hours after being extubated will be recorded.
Title
PH
Description
PH change after extubation
Time Frame
Change from baseline of PH at the 1, 2, 4, 8, 12 and 24th hour after extubation
Title
PO2
Description
PO2 change after extubation
Time Frame
Change from baseline of PO2 at the 1, 2,4 , 8, 12 and 24th hour after extubation
Title
Mean Arterial Pressure (MAP)
Description
MAP change after extubation
Time Frame
Change from baseline of MAP at the 1, 2, 4, 8, 12 and 24th hour after extubation
Title
PCO2
Description
PCO2 change after extubation
Time Frame
Change from baseline of PCO2 change at the 1, 2, 4, 8, 12 and 24th hour after extubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Between the ages of 18-65, Coronary artery patients with normal left ventricular function and scheduled for elective coronary artery bypass surgery, Valve diseases for which elective valve replacement is planned with normal left ventricular function, Cases of ASD (Atrial Septal Defect) for atrial septal defect closure Patients who will have elective valve + coronary artery bypass without left ventricular dysfunction and patients who volunteer to participate in the study, No coagulation disorder Patients with a platelet count of more than 100,000, Patients with good mental status, Patients with an ejection difference value (E/F) above 50% will be included in the study. Exclusion Criteria: Cases that will require emergency and repeat heart surgery, With advanced left coronary artery disease and left ventricular dysfunction, Receiving preoperative inotropic support therapy for any reason, Mitral stenosis with atrial thrombus, Patients with low cardiac out put syndrome and E/F below 50%, Patients who need intra-aortic balloon pump during surgery, Patients with bleeding and coagulation disorders, Patients with hepatic and renal dysfunction, Patients with Uncontrolled Diabetes Mellitus and Chronic Obstructive Pulmonary Disease, Patients allergic to opioids, analgesics and bupivacaine, Patients with atrial fibrillation using anticoagulants, Patients with cognitive dysfunction Patients who do not want to participate in the study will be excluded from the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yavuz Orak
Phone
05324717056
Email
dryavuzorak@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Metin Ege
Phone
05464337183
Email
metinege1994@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yavuz Orak
Organizational Affiliation
Kahramanmaraş Sütçü İmam Üniversitesi Tıp Fakültesi, Anesteziyoloji ve Reanimasyon Bölümü
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kahramanmaras Sutcu Imam University Faculty of Medicine
City
Kahramanmaraş
ZIP/Postal Code
46040
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yavuz Orak, MD,PhD
Phone
05324717056
Email
dryavuzorak@hotmail.com
First Name & Middle Initial & Last Name & Degree
Metin Ege
Phone
0 546 433 71 83
Email
metinege1994@hotmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

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Serratus Anterior Plan Block and Postoperative Pain in Patients Who Underwent Minimally Invasive Cardiac Surgery

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