Errector Spinae Plane Block for Postoperative Pain Management in Cardiac Surgery: A Randomized Controlled Trial
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2020
CompletedFirst Submitted
Initial submission to the registry
June 3, 2020
CompletedFirst Posted
Study publicly available on registry
June 9, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedJuly 8, 2020
July 1, 2020
7 months
June 3, 2020
July 7, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
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)
baseline and hours 3-6-12-24-36-48
time to mobilize the patient
time to mobilize the patient is reported as when the patient is mobilized
Any time for 7 days
Study Arms (2)
esp block group
EXPERIMENTALcontrol group
ACTIVE COMPARATORInterventions
ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.
Eligibility Criteria
You may qualify if:
- Must be ASA score I-III
- Must be 18-75 years old
- must undergo cardiac surgery
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department
Aydin, 09100, Turkey (Türkiye)
Related Publications (2)
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.
PMID: 30052229BACKGROUNDKrishna 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.
PMID: 30055991BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Sinem Sari, Assoc Prof
Adnan Menderes University Medical Faculty Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc. Prof. Dr.
Study Record Dates
First Submitted
June 3, 2020
First Posted
June 9, 2020
Study Start
June 1, 2020
Primary Completion
January 1, 2021
Study Completion
June 1, 2021
Last Updated
July 8, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share