Serratus Posterior Superior Intercostal Plane Block (SPSIPB)NCT07232992
Serratus Posterior Superior Intercostal Plane Block for Postoperative Analgesia in Open-Heart Surgery
A study testing SPSIPB blcok, Parasternal blocks and Local Infiltration in people with Serratus Posterior Superior Intercostal Plane Block (SPSIPB) and Open-heart Surgery, run by Bursa City Hospital at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Serratus Posterior Superior Intercostal Plane Block (SPSIPB), Open-heart Surgery
- What is being tested?
- SPSIPB blcok, Parasternal blocks and Local Infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2026to 15 Apr 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-85 years with ASA physical status II-III undergoing elective open-heart surgery.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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.
Read the detailed description
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.
- Being tested
- SPSIPB blcok, Parasternal blocks, Local Infiltration
- Keywords
- open-heart surgery, Serratus Posterior Superior Intercostal Plane Block (SPSIPB), postoperative analgesia, parasternal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SPSIPB blcokOther
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 blocksOther
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 InfiltrationOther
Local anesthetic infiltration (10 mL of 0.25% bupivacaine) will be administered around the chest tube and mediastinal drain sites.
| Study group | Role | What they receive |
|---|---|---|
| Group SPSIPB | Active comparator | It will be administered bilaterally before the induction of general anesthesia. Receives: Other: SPSIPB blcok |
| Group Control | Active comparator | Parasternal block and local infiltration at the drain insertion site. Receives: Other: Parasternal blocks; Other: Local Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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")
Postoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
Measured: 0, 2, 4, 8, 16 and 24 hours
Global recovery scoring system (patient satisfaction scale)- QoR-15
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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start15 Jan 2026
- Primary completion15 Apr 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Serratus Posterior Superior Intercostal Plane Block (SPSIPB)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bursa City Hospital
- Sponsor type
- Other government
- Collaborators
- Ulusoy, Emre, M.D.
- Responsible party
- Principal investigator, eralp çevikkalp, Bursa City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07232992
- Sponsor's protocol ID
- Bursa City Hospital 003
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 29 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared
Publications
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.
PubMed 39103782