Actively Recruiting
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
Led by Tanta University · Updated on 2026-03-17
66
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the pain relief effects of two different ultrasound-guided nerve block techniques in patients undergoing cardiac surgery involving a sternotomy. The study aims to compare the erector spinae plane block with a combination of pecto-intercostal fascial plane block and recto-intercostal fascial plane block to see which provides better postoperative pain control. This research addresses the high incidence of severe acute pain after median sternotomy and seeks to improve analgesic options for such patients. The study involves two groups: one receiving the erector spinae plane block with 20 ml of 0.25% bupivacaine injected on each side near the fourth thoracic vertebra, and the other receiving combined pecto-intercostal and recto-intercostal fascial plane blocks with 10-15 ml of 0.25% bupivacaine injected at specified chest locations on each side. Both procedures are guided by ultrasound and doses are carefully controlled to stay within safe limits. The blocks are performed during cardiac surgery that uses cardiopulmonary bypass and midline sternotomy. Participants will be monitored for total opioid use in the first 24 hours after surgery, pain scores at multiple time points up to 48 hours, intraoperative fentanyl dosage, extubation time, side effects, and incidence of chronic pain at 3 and 6 months. The study includes double-blind randomization to either treatment group. Safety and analgesic effectiveness will be closely assessed during and after surgery, with follow-up extending to 6 months to evaluate long-term pain outcomes.
CONDITIONS
Brief Title
Erector Spinae Block Versus Combined Pecto-intercostal and Recto-intercostal Fascial Plane Block in Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age from 21 to 65 years.
- Both sexes.
- Scheduled for open heart surgery with cardiopulmonary bypass and midline sternotomy.
You will not qualify if you...
- 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 such as hepatic or renal failure.
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - During surgery
Participants receive one of two regional nerve block interventions under ultrasound guidance during cardiac surgery to manage postoperative pain.
1 visit (in-person, during surgery)
Duration - 48 hours after surgery
Participants are monitored for pain levels, opioid consumption, side effects, and extubation time following surgery.
Multiple assessments at extubation and at 8, 12, 18, 24, 36, and 48 hours after surgery
Duration - Up to 6 months after surgery
Participants are followed to assess incidence of chronic pain after surgery.
Follow-up visits at 3 and 6 months after surgery
Trial Site Locations
Total: 1 location
1
Tanta University Hospitals
Tanta, Gharbia Governorate, Egypt, 31527
Actively Recruiting
Research Team
O
Osama M Rehab, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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