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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04420104
• Other study ID #: AMU
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: July 2020
• Source: Aydin Adnan Menderes University
• Contact: Sinem Sari, Assoc Prof
• Phone: 90 507 539 63 13
• Email: sarisinem[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to assess efficacy of erector spinae plane block (ESP) for postoperative pain management in cardiac surgery patients.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• Cardiac Surgery
• Erector Spinae Plane Block
• Pain, Postoperative

Intervention

Procedure:
• erector spinae plane block
ESP Block: Bilateral ESP block and with ultrasound guidance will be applied A total 40 ml, 20 ml bupivacaine 0.5%, 20 ml saline.

Drug:
• iv analgesia
iv contromal

Locations

Country	Name	City	State
Turkey	Adnan Menderes University Medical Faculty, Anesthesiology and Reanimation Department	Aydin

Sponsors (1)

Lead Sponsor	Collaborator
Aydin Adnan Menderes University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	time to mobilize the patient	time to mobilize the patient is reported as when the patient is mobilized	Any time for 7 days