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

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Procedure: Erector spinae block; Drug: Fentanyl

• Registration Number: NCT05769309
• Lead Sponsor: Menoufia University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2023-02-12
• Study First Submitted QC: 2023-03-13
• Study First Posted: 2023-03-15
• Study Start: 2023-03-22
• Primary Completion: 2023-10-10
• Study Completion: 2023-12-25
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-17
• Last Update Posted: 2024-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Erector spinae block group	Erector spinae block	the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine
Erector spinae block group	Fentanyl	the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine
control group	Fentanyl	no block will be done but only IV analgesia.

Primary Outcome Measures

Name	Time	Method
Total intraoperative and postoperative opioid consumption	48 hours	Microgram and mg

Secondary Outcome Measures

Name	Time	Method
time of chest drain removal	5 days	hours
time of intensive care unit stay	one week	hours
The heart rate	48 hours	Beats per minutes
mean arterial blood pressure	48 hours	mmHg
pain intensity at rest and movement	48 hours	numerical rating score from zero to ten ( 0=no pain, 10 =severe pain )
time to extubation	24hours	min
time to ambulation	24hours	hours
time to oral intake	48 hours	hours
time to first rescue analgesia	24hous	minutes
Duration of mechanical ventilation	24 hours	hours

Trial Locations

Locations (1)

Menoufia university; 🇪🇬 Cairo, Shibin Elkom, Egypt