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The Effect of Bilateral Erector Spina Plane Block on Postoperative Pain in Adult Cardiac Surgery.

Primary Purpose

Postoperative Pain, Opioid Use

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Erector Spinae Plane Block
Sponsored by
Kahramanmaras Sutcu Imam University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Postoperative Pain

Eligibility Criteria

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

Inclusion Criteria:

  • Male and / or female patients aged 18-65 will be included in the study.
  • Normal left ventricular function (alternating one, two and three vessels).
  • coronary artery patients scheduled for elective coronary artery surgery under cardiopulmonary bypass,
  • Valvular diseases planned for elective valve replacement with normal left ventricular function, ASD (Atrial Septal Defect) cases for atrial septal defect closure, and patients without left ventricular dysfunction (E / F≥ 50-55%) elective valve + CABG will be included in the study.

Exclusion Criteria:

  • Patients requiring acute coronary syndrome and emergency cardiovascular surgery,
  • Patients who have had myocardial infarction within the past month
  • Recurrent cardiovascular surgery
  • Off-pump coronary artery bypass surgery (OPCAB)
  • Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients
  • Patients with chronic renal failure, liver disease, active infection
  • Patients older than 80 years and smaller than 18 years
  • Patients with coagulation disorders

Sites / Locations

  • Kahramanmaras Sutcu Imam University Faculty of Medicine
  • Yavuz Orak

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group ESP

Group Control

Arm Description

While the patient is in a sitting position, A ultrasound probe covered with a sterile sheath will be placed approximately 2 cm to the right or left of the T 4-5 spinous process. After the T 4-5 transverse process and the erector spinae muscle above it are shown, a quincke-type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal with the entrance made using the in-plane technique. When the transverse process is touched, the needle will be pulled out and a local anesthetic solution will be applied to the fascia beneath the erector spinae muscle. A 20 mL dose of 0.25% bupivacaine, which has been shown to spread both above and below the T 4-5 level, will be injected.The same procedure will be repeated on the contralateral side of the T5 spinous process and half of the remaining bupivacaine dose will be injected. The total volume of bupivacaine injected on both sides will be 20 mL.

No block will be made to the control group. After extubation, 1mg / kg tramadol will be applied routinely to both groups, and PCA (Patient Control Analgesia) and morphine consumption and VAS (visual analog scale) pain scores of both groups will be evaluated and recorded at the 1st, 4th, 12th and 24th hour. When VAS is 3, patients will be advised to press the PCA device.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Pain (VAS Score)
Change from Baseline VAS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated

Full Information

First Posted
May 17, 2021
Last Updated
April 18, 2022
Sponsor
Kahramanmaras Sutcu Imam University
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1. Study Identification

Unique Protocol Identification Number
NCT04906239
Brief Title
The Effect of Bilateral Erector Spina Plane Block on Postoperative Pain in Adult Cardiac Surgery.
Official Title
The Effect of Bilateral Erector Spina Block on Postoperative Pain in Adult Cardiac Surgery: A Randomized, Clinical Study.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
February 15, 2022 (Actual)
Study Completion Date
March 15, 2022 (Actual)

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
Failure to adequately prevent pain after heart surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. Aim in this study is to investigate analgesic consumption and postoperative pain effect in patients who underwent cardiopulmonary bypass with Erector Spinae Block, a new block.
Detailed Description
Failure to adequately prevent pain after heart surgery increases morbidity and results in a high incidence of persistent poststernotomy pain syndrome. The use of special opioid-based analgesia causes adverse effects such as nausea, vomiting, sedation, urinary retention, respiratory depression and delayed tracheal extubation. Regional anesthesia techniques such as pectoralis nerve block and serratus anterior block provide analgesia in the sternum and protection from pain in the lateral / posterior chest wall. Ketamine and a2 agonists were used for intravenous analgesia to reduce opioid consumption. However, these drugs have potential side effects that limit their extensive clinical use as analgesic agents. The use of regional anesthetic techniques, e.g. thoracic epidural and thoracic paravertebral block, dural puncture, epidural hematoma, spinal cord injury, hypotension, pneumothorax, epidural abscess, ipsilateral Horner's syndrome Their use has declined due to the high failure rate of as much as 15% (especially for the thoracic epidural) and the significant possibility of complications. Erector spinae (ESP) block, a new method, provides a wide multi dermatomal sensory block. In the T 4-5 spinous process, the bilateral ESP block provides analgesia from T2 to T9 sensory level and results in both somatic and visceral analgesia by blocking both the dorsal and ventral of the spinal nerves, including the sympathetic chain. This block can provide sufficient analgesia for the median sternotomy because the main nerve supply to the sternal region is from T2 to T6. Our aim in this study is to investigate analgesic consumption and postoperative pain effect in patients who underwent cardiopulmonary bypass with Erector Spina Block, a new block.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Opioid Use

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group ESP
Arm Type
Active Comparator
Arm Description
While the patient is in a sitting position, A ultrasound probe covered with a sterile sheath will be placed approximately 2 cm to the right or left of the T 4-5 spinous process. After the T 4-5 transverse process and the erector spinae muscle above it are shown, a quincke-type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal with the entrance made using the in-plane technique. When the transverse process is touched, the needle will be pulled out and a local anesthetic solution will be applied to the fascia beneath the erector spinae muscle. A 20 mL dose of 0.25% bupivacaine, which has been shown to spread both above and below the T 4-5 level, will be injected.The same procedure will be repeated on the contralateral side of the T5 spinous process and half of the remaining bupivacaine dose will be injected. The total volume of bupivacaine injected on both sides will be 20 mL.
Arm Title
Group Control
Arm Type
No Intervention
Arm Description
No block will be made to the control group. After extubation, 1mg / kg tramadol will be applied routinely to both groups, and PCA (Patient Control Analgesia) and morphine consumption and VAS (visual analog scale) pain scores of both groups will be evaluated and recorded at the 1st, 4th, 12th and 24th hour. When VAS is 3, patients will be advised to press the PCA device.
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block
Intervention Description
A high-frequency ultrasound linear probe, covered with a sterile sheath, will be placed approximately 2 cm to the right or left of the T 4-5 spinous process. After showing the T 4-5 transverse process and the erector spinae muscle on top of it, a 22-gauge, 80 mm insulated quincke type needle will be inserted into the skin at an angle of approximately 30 degrees from cranial to caudal, using the in-plane technique. When the transverse process is touched, the needle will be pulled out and after a negative aspiration test with 0.5 mL of normal saline and after the demonstration of a hypo-echogenic image and hydro dissection, a local anesthetic solution will be applied to the fascia beneath the erector spinae muscle. A 20 mL dose of 0.25% bupivacaine, which has been shown to spread both above and below the T 4-5 level, will be injected.
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 1, 4, 12 and 24 hours after extübation
Secondary Outcome Measure Information:
Title
Pain (VAS Score)
Description
Change from Baseline VAS Score. from 1 to 10 , 0: No pain, 10: 10 pain that can not be tolerated
Time Frame
Change From Baseline of VAS Score at 1, 4, 12 and 24 hours after being extubated will be recorded.

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: Male and / or female patients aged 18-65 will be included in the study. Normal left ventricular function (alternating one, two and three vessels). coronary artery patients scheduled for elective coronary artery surgery under cardiopulmonary bypass, Valvular diseases planned for elective valve replacement with normal left ventricular function, ASD (Atrial Septal Defect) cases for atrial septal defect closure, and patients without left ventricular dysfunction (E / F≥ 50-55%) elective valve + CABG will be included in the study. Exclusion Criteria: Patients requiring acute coronary syndrome and emergency cardiovascular surgery, Patients who have had myocardial infarction within the past month Recurrent cardiovascular surgery Off-pump coronary artery bypass surgery (OPCAB) Patients with chronic inflammatory disease (rheumatoid arthritis, malignancy, psoriasis, etc.), autoimmune disease, immunocompromised patients Patients with chronic renal failure, liver disease, active infection Patients older than 80 years and smaller than 18 years Patients with coagulation disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yavuz Orak, MD, PhD
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
Facility Name
Yavuz Orak
City
Kahramanmaraş
ZIP/Postal Code
46040
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Bilateral Erector Spina Plane Block on Postoperative Pain in Adult Cardiac Surgery.

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