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NCT Number: NCT05769309

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

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.

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Key information

Conditions

Postoperative Pain Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Menoufia university

Cairo, Shibin Elkom, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

erector spinae block

Procedure

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

Fentanyl

Drug

fentanyl boluses of 0.5-to-1 µg/kg titrated according to haemodynamic parameters.

Primary outcomes

  1. Total intraoperative and postoperative opioid consumption

    Time frame: 48 hours

    Microgram and mg

Secondary outcomes

  1. pain intensity at rest and movement

    Time frame: 48 hours

    numerical rating score from zero to ten ( 0=no pain, 10 =severe pain )

  2. time to first rescue analgesia

    Time frame: 24hous

    minutes

  3. Duration of mechanical ventilation

    Time frame: 24 hours

    hours

  4. time to extubation

    Time frame: 24hours

    min

  5. time to ambulation

    Time frame: 24hours

    hours

  6. time to oral intake

    Time frame: 48 hours

    hours

  7. time of chest drain removal

    Time frame: 5 days

    hours

  8. time of intensive care unit stay

    Time frame: one week

    hours

  9. The heart rate

    Time frame: 48 hours

    Beats per minutes

  10. mean arterial blood pressure

    Time frame: 48 hours

    mmHg

Sponsors and collaborators

Lead sponsor

Menoufia University

Other

Registry information

Official study title

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

Acronym: ESPB

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 15, 2023
Registry last updated
Mar 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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