Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Open-Heart Surgery
The Effectiveness of the Serratus Posterior Superior Intercostal Plane Block on Postoperative Analgesia and Recovery in Open-heart Surgery: A Prospective, Double-blind, Randomized Controlled Trial.
1 other identifier
interventional
70
1 country
1
Brief Summary
Postoperative pain following open-heart surgery is a significant challenge that may negatively affect recovery and overall clinical outcomes. Due to the risks and contraindications associated with neuraxial techniques, the use of fascial plane blocks has increased in recent years. In patients undergoing cardiac surgery, the location and intensity of postoperative pain may vary daily. However, during the first 24 hours, pain is typically most pronounced at the median sternotomy incision site and at the insertion sites of chest, mediastinal, and pleural drains. Current postoperative analgesia practices in open-heart surgery commonly include multimodal regimens using simple analgesics such as paracetamol and nonsteroidal anti-inflammatory drugs, combined with a regional anesthesia technique such as the parasternal block. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is an interfascial plane block that involves the injection of local anesthetic between the serratus posterior superior and intercostal muscles, providing wide dermatomal coverage from the upper cervical to lower thoracic regions. Although the technique has been used successfully in individual clinical cases, no randomized controlled studies have been conducted to evaluate its efficacy in open-heart surgery. This study aims to compare the postoperative analgesic effectiveness of the SPSIPB with a combination of parasternal block and local anesthetic infiltration at drain insertion sites in patients undergoing open-heart surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jan 2026
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 14, 2025
CompletedFirst Posted
Study publicly available on registry
November 18, 2025
CompletedStudy Start
First participant enrolled
January 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2026
CompletedApril 29, 2026
November 1, 2025
3 months
November 14, 2025
April 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
opioid consumption
Fentanyl will be prepared at a concentration of 10 µg/mL, and patient-controlled analgesia (PCA) will be administered without a basal infusion, using a lock-out interval of 20 minutes and a bolus dose of 20 µg.
0, 2, 4, 8, 16 and 24 hours
Secondary Outcomes (2)
Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")
0, 2, 4, 8, 16 and 24 hours
Global recovery scoring system (patient satisfaction scale)- QoR-15
The quality of recovery will be evaluated out of a total of 150 points according to the QoR-15 test to be applied at the portoperative 24th hour.
Study Arms (2)
Group SPSIPB
ACTIVE COMPARATORIt will be administered bilaterally before the induction of general anesthesia.
Group Control
ACTIVE COMPARATORParasternal block and local infiltration at the drain insertion site.
Interventions
Under aseptic conditions, an ultrasound-guided procedure will be performed using a linear probe (GE ML6-15-D Matrix Linear). After identifying the second and third ribs, a 22-gauge, 50-mm short-bevel needle (Stimuplex Ultra®, Braun, Melsungen, Germany) will be advanced in-plane in a caudocranial direction. Following hydrodissection with 5 mL of saline to confirm correct needle placement, 20 mL of 0.25% bupivacaine will be injected bilaterally into the fascial plane.
Before intubation, the block will be performed under aseptic conditions using a high-frequency ultrasound probe (GE ML6-15-D Matrix Linear, Boston, USA) placed immediately lateral to the sternum after identifying the second to fourth intercostal spaces. An 50-mm echogenic block needle (Stimuplex Ultra®, Braun, Melsungen, Germany) will then be advanced using an in-plane approach from the skin toward the plane between the pectoralis major and intercostal muscles. A total of 10 mL of 0.25% bupivacaine will be injected bilaterally.
Local anesthetic infiltration (10 mL of 0.25% bupivacaine) will be administered around the chest tube and mediastinal drain sites.
Eligibility Criteria
You may qualify if:
- Patients aged 18-85 years with ASA physical status II-III undergoing elective open-heart surgery.
You may not qualify if:
- Patients who do not consent to participate in the study
- Patients with coagulopathy
- History of allergy or toxicity to local anesthetics
- Patients with hepatic or renal failure
- Patients with uncontrolled diabetes mellitus
- Patients with uncontrolled hypertension
- Mentally disabled patients
- Patients receiving chronic pain therapy (opioid use)
- Use of antidepressant medication
- Presence of neuropathic pain
- Presence of infection at the injection site
- Pregnant, suspected pregnant, or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bursa City Hospitallead
- Ulusoy, Emre, M.D.collaborator
Study Sites (1)
Bursa City Hospital
Bursa, Turkey (Türkiye)
Related Publications (1)
Zengin EN, Yigit H, Cobas M, Salman N, Asli Demir Z. The analgesic effects of combined bilateral parasternal block and serratus anterior plane block for coronary artery bypass grafting surgery. BMC Anesthesiol. 2024 Aug 5;24(1):274. doi: 10.1186/s12871-024-02659-7.
PMID: 39103782BACKGROUND
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assoc prof
Study Record Dates
First Submitted
November 14, 2025
First Posted
November 18, 2025
Study Start
January 15, 2026
Primary Completion
April 15, 2026
Study Completion
April 15, 2026
Last Updated
April 29, 2026
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share
Individual participant data (IPD) will not be shared