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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Erector spinae block; Drug: Fentanyl

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: AMAL G SAFAN, MD; Phone Number: 02 01027386221; Email: [email protected]
• Study Contact Backup: Name: Abd-Elazeem A Elbakry, MD; Phone Number: 02 01021678889; Email: [email protected]

Study Locations

• Egypt
  • Shibin Elkom
    • Cairo, Shibin Elkom, Egypt
      • Recruiting
      • Menoufia University
      • Contact: AMAL G SAFAN, MD; Phone Number: 0102738621; Email: [email protected]
      • Contact: Abd-Elazeem A Elbakry, MD; Phone Number: 01021678889; Email: [email protected]

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Erector spinae block group; the patients will be administered bilateral Erector spinae block with 20 ml of 0.25 % bupivacaine	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.
Other: control group; no block will be done but only IV analgesia.	Drug: Fentanyl; fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total intraoperative and postoperative opioid consumption	Microgram and mg	48 hours

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Menoufia University
• Investigators: Principal Investigator: Abd-Elazeem A Elbakry, MD, Menoufia University; Principal Investigator: Amal G Safan, MD, Menoufia University; Principal Investigator: Islam M ElDesoky, MD, Menoufia University

Study record dates

Study Major Dates

• Study Start (Anticipated): March 1, 2023
• Primary Completion (Anticipated): August 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 12, 2023
• First Submitted That Met QC Criteria: March 13, 2023
• First Posted (Actual): March 15, 2023

Study Record Updates

• Last Update Posted (Actual): March 15, 2023
• Last Update Submitted That Met QC Criteria: March 13, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: 2/2023 ANET10-2

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No