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NCT Number: NCT07232992

Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Open-Heart Surgery

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.

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Key information

Conditions

Serratus Posterior Superior Intercostal Plane Block (SPSIPB) Open-heart Surgery

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bursa City Hospital

Bursa, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients aged 18-85 years with ASA physical status II-III undergoing elective open-heart surgery.

Exclusion criteria

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

Treatment and study plan

SPSIPB blcok

Other

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.

Parasternal blocks

Other

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 infiltration

Other

Local anesthetic infiltration (10 mL of 0.25% bupivacaine) will be administered around the chest tube and mediastinal drain sites.

Primary outcomes

  1. opioid consumption

    Time frame: 0, 2, 4, 8, 16 and 24 hours

    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.

Secondary outcomes

  1. Postoperative pain scores (Numerical rating scale) (0-meaning "no pain" to 10-meaning "worst pain imaginable")

    Time frame: 0, 2, 4, 8, 16 and 24 hours

    Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.

  2. Global recovery scoring system (patient satisfaction scale)- QoR-15

    Time frame: 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.

    Researchers will use the Turkish version of the Quality Improvement Survey/QoR-15. PART A: Participants will be asked by researchers how they felt in the last 24 hours.(0 to 10, where: 0 = none of the time [poor] and 10 = all of the time [excellent]) 1. Able to breathe easily 2. Been able to enjoy food 3. Feeling rested 4. Have had a good sleep 5. Able to look after personal toilet and hygiene unaided 6. Able to communicate with 7. Getting support from hospital doctors and nurses 8. Able to return to work or usual home activities 9. Feeling comfortable and in control 10. Having a feeling of general well-being PART B Participants will be asked by the researchers whether they have experienced any of the following in the last 24 hours. (10 to 0, where: 10 = none of the time [excellent] and 0 = all of the time [poor]) 11. Moderate pain 12. Severe pain 13. Nausea or vomiting 14. Feeling worried or anxious 15. Feeling sad or depressed

Sponsors and collaborators

Lead sponsor

Bursa City Hospital

Other Gov

Collaborators

  • Ulusoy, Emre, M.D.

Registry information

Official study title

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.

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Nov 18, 2025
Registry last updated
Apr 29, 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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