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Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial

Primary Purpose

Erector Spinae Plane Block, Cardiac Surgery

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
erector spinae plane block
iv analgesia
Sponsored by
Aydin Adnan Menderes University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Erector Spinae Plane Block

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Must be ASA score I-III
  • Must be 18-75 years old
  • must undergo cardiac surgery

Exclusion Criteria:

  • emergency surgery,
  • bleeding diathesis,
  • presence of contraindications to LA agents used in this study,
  • use of chronic opioids,
  • psychiatric disorders.
  • prolonged extubation
  • presence of infection at the injection site.
  • cardiovascular conditions (EF<40, LMCA obstruction)

Sites / Locations

  • Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation DepartmentRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

esp block group

control group

Arm Description

Outcomes

Primary Outcome Measures

change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.
The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline)
time to mobilize the patient
time to mobilize the patient is reported as when the patient is mobilized

Secondary Outcome Measures

Full Information

First Posted
June 3, 2020
Last Updated
July 7, 2020
Sponsor
Aydin Adnan Menderes University
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1. Study Identification

Unique Protocol Identification Number
NCT04420104
Brief Title
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
Official Title
Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 1, 2020 (Actual)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aydin Adnan Menderes 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
The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.
Detailed Description
After being informed about the study and potential risks, all patients giving written informed consent will be randomised (single blind) as block group(patients is performed esp block) and control group. All patients will be evaluate during 48 hours for postoperative pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erector Spinae Plane Block, Cardiac Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
esp block group
Arm Type
Experimental
Arm Title
control group
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block
Intervention Description
ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
Intervention Type
Drug
Intervention Name(s)
iv analgesia
Intervention Description
iv contromal
Primary Outcome Measure Information:
Title
change from baseline in pain the 10 point Visual Analog Scale (VAS) at hours 3,6,9,12,24,36,48.
Description
The VAS is validated instrument assessing average pain. Possible scores range from 0 (no pain) to 10 (worst possible pain) Change= (hours 3,6,9,12,24,48 score- baseline)
Time Frame
baseline and hours 3-6-12-24-36-48
Title
time to mobilize the patient
Description
time to mobilize the patient is reported as when the patient is mobilized
Time Frame
Any time for 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Must be ASA score I-III Must be 18-75 years old must undergo cardiac surgery Exclusion Criteria: emergency surgery, bleeding diathesis, presence of contraindications to LA agents used in this study, use of chronic opioids, psychiatric disorders. prolonged extubation presence of infection at the injection site. cardiovascular conditions (EF<40, LMCA obstruction)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sinem Sari, Assoc Prof
Phone
90 507 539 63 13
Email
sarisinem@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sinem Sari, Assoc Prof
Organizational Affiliation
Adnan Menderes University Medical Faculty Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
City
Aydın
ZIP/Postal Code
09100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
sinem sari
Phone
090 4441256-2108
Email
sarisinem@yahoo.com
First Name & Middle Initial & Last Name & Degree
Pelin Dilsiz
First Name & Middle Initial & Last Name & Degree
Nil Kaan
First Name & Middle Initial & Last Name & Degree
Erdem Ali Ozkisacik
First Name & Middle Initial & Last Name & Degree
Tunay Kurtoglu
First Name & Middle Initial & Last Name & Degree
Varlik Erel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30052229
Citation
Nagaraja PS, Ragavendran S, Singh NG, Asai O, Bhavya G, Manjunath N, Rajesh K. Comparison of continuous thoracic epidural analgesia with bilateral erector spinae plane block for perioperative pain management in cardiac surgery. Ann Card Anaesth. 2018 Jul-Sep;21(3):323-327. doi: 10.4103/aca.ACA_16_18.
Results Reference
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PubMed Identifier
30055991
Citation
Krishna SN, Chauhan S, Bhoi D, Kaushal B, Hasija S, Sangdup T, Bisoi AK. Bilateral Erector Spinae Plane Block for Acute Post-Surgical Pain in Adult Cardiac Surgical Patients: A Randomized Controlled Trial. J Cardiothorac Vasc Anesth. 2019 Feb;33(2):368-375. doi: 10.1053/j.jvca.2018.05.050. Epub 2018 Jun 4. Erratum In: J Cardiothorac Vasc Anesth. 2022 Feb;36(2):627.
Results Reference
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Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial

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