Efficacy of Erector Spinae Plane Block Analgesia After Off Pump Cardiac Surgery

Postoperative Pain Clinical Trial

— ESPB  

Official title:

Efficacy of Erector Spinae Plane Block on Postoperative Analgesia and Recovery After Off Pump Cardiac Surgery: A Randomised Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769309
• Other study ID #: 2/2023 ANET10-2
• Status: Completed
• Phase: N/A
• Start date: March 22, 2023
• Est. completion date: December 25, 2023

Study information

• Verified date: March 2024
• Source: Menoufia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study the investigators will investigate the efficacy of ESPB as a part of Enhanced recovery after surgery on postoperative analgesia and recovery criteria after off pump cardiac surgery.

Description:

General anaesthesia will be induced by 0.05 mg/kg midazolam, 3 µg/kg fentanyl, 1-2mg/kg propofol, and 0.5mg/kg of Atracurium. After induction, bilateral erector spinae plane block will be performed in the block group. Intraoperative analgesia will be achieved by fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters. Postoperative analgesia will be managed by paracetamol 1000 mg /6hours and morphine 1-2mg boluses when pain score ≥4 1 to 2 mg to be repeated every 5 minutes if needed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 25, 2023
• Est. primary completion date: October 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• age 18-70 years

• ejection fraction of > 45%

• undergoing elective off-pump cardiopulmonary bypass surgery

Exclusion Criteria:

• vertebral anomalies

• intra-aortic balloon pump in the preoperative period

• acute myocardial infarction

• local infection at the site of block

• allergy to the local anesthetic used

• morbid obesity, psychiatric disorders, neurologic deficits, alcohol and chronic opioid abuse, and patients with bleeding diathesis.

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Procedure:
• Erector spinae block
After induction, the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine

Drug:
• Fentanyl
fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.

Locations

Country	Name	City	State
Egypt	Menoufia university	Cairo	Shibin Elkom

Sponsors (1)

Lead Sponsor	Collaborator
Menoufia University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total intraoperative and postoperative opioid consumption	Microgram and mg	48 hours
Secondary	pain intensity at rest and movement	numerical rating score from zero to ten ( 0=no pain, 10 =severe pain )	48 hours
Secondary	time to first rescue analgesia	minutes	24hous
Secondary	Duration of mechanical ventilation	hours	24 hours
Secondary	time to extubation	min	24hours
Secondary	time to ambulation	hours	24hours
Secondary	time to oral intake	hours	48 hours
Secondary	time of chest drain removal	hours	5 days
Secondary	time of intensive care unit stay	hours	one week
Secondary	The heart rate	Beats per minutes	48 hours
Secondary	mean arterial blood pressure	mmHg	48 hours