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NCT Number: NCT06870383

Erector Spinae Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Cardiac Surgery

The aim of this study is to compare the analgesic effects of ultrasound-guided bilateral erector spinae plane block versus ultrasound-guided bilateral combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.

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This study is active but is not currently recruiting participants.

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Key information

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, Gharbia Governorate, 31527, Egypt

About this study

The incidence of severe acute postoperative pain after median sternotomy is as high as 49 %. A number of regional techniques have been used to treat sternotomy pain such as thoracic epidural, intercostal nerve block, paravertebral nerve block & thoracic erector spinae plane block which has been used extensively in cardiac surgery providing adequate postoperative pain control. Pecto-intercostal fascial plane block is a minimally invasive, regional fascial plane block technique that can be administered as a part of a multimodal analgesic regimen. It targets the anterior intercostal nerves as they run in the fascial plane between the pectoralis major muscle and the external intercostal muscles and emerge on either side of the sternum. Recently, Tulgar et al. have described a novel block named "recto-intercostal fascial plane block" which is performed between the rectus abdominis muscle and costal cartilages of ribs 6-7 (insertion of RAM). In their cadaveric examination, they reported that the dye spread extensively to the anterior branches of the T6-T9 thoracic nerves, and laterally to the entire lower thorax. The investigators assume that the incomplete dermatome coverage by Pecto-intercostal fascial plane block might be responsible for its inferior analgesic quality compared to erector spinae plane block which was reported in some previous reports. So, the investigators will conduct this novel study to investigate and compare the analgesic effects of erector spinae plane block and combined Pecto-intercostal fascial plane block and recto-intercostal fascial plane block in patients undergoing cardiac surgery.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age from 21 to 65 years.
  • Both sexes.
  • Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.

Exclusion criteria

  • History of chronic pain or Long-term or recent use of opioids.
  • History of allergy to local anesthetic drugs.
  • Ejection fraction of left ventricle less than 30%.
  • History of psychiatric diseases or any neurological disorders.
  • Pre-existing major organ dysfunction as hepatic or renal failure.

Treatment and study plan

Erector Spinae Plane Block

Drug

The block will be done under ultrasound guidance using 20 ml bupivacaine 0.25% that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose.

Combined Pecto-intercostal and recto-intercostal fascial plane block

Drug

The blocks will be done under ultrasound guidance using 10-15 ml of 0.25% bupivacaine that will be injected for each side ensuring not to exceed the maximal 2 mg/kg bupivacaine dose..

Primary outcomes

  1. The total opioid consumption in first 24 hours after surgery.

    Time frame: 24 hours after surgery.

    opioid analgesia will be given if the pain scores ≥ 4.

Secondary outcomes

  1. Intraoperative fentanyl dose

    Time frame: Until the end of surgical procedure.

    Fentanyl bolus dosages of 2μg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline.

  2. Postoperative pain scores after extubation, at 8, 12, 18, 24, 36, and 48 hour after surgery.

    Time frame: 48 hours after surgery.

    Numerical rating scale pain score (NRS) ranges from 0= no pain to 10= worst pain will be used to evaluate pain scores after surgery.

  3. Extubation time

    Time frame: 24 hours after surgery.

    Time from intensive care unit admission until successful removal of endotracheal tube will be recorded.

  4. Side effects

    Time frame: 24 hours after surgery.

    Hypotension , bradycardia, postoperative nausea and vomiting

  5. Incidence of chronic pain at 3, and 6 months after surgery.

    Time frame: 6 months after surgery.

    chronic pain will be assessed and its severity graded by rating scale will be recorded.

  6. Opioid consumption in the second day after surgery.

    Time frame: 48 hours after surgery.

    opioid analgesia will be given if the pain scores ≥ 4.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Analgesic Efficacy of Erector Spinae Plane Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Patients Undergoing Cardiac Surgery: A Randomized Comparative Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Mar 11, 2025
Registry last updated
Jul 6, 2026

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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