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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.

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07232992
Enrollment
70
Registered
2025-11-18
Start date
2026-01-15
Completion date
2026-04-15
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

open-heart surgery, Serratus Posterior Superior Intercostal Plane Block (SPSIPB), postoperative analgesia, parasternal block

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.

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.

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.

OTHERLocal Infiltration

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

Sponsors

Emre ULUSOY
CollaboratorUNKNOWN
Bursa City Hospital
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
opioid consumption0, 2, 4, 8, 16 and 24 hoursFentanyl 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

MeasureTime frameDescription
Postoperative pain scores (Numerical rating scale) (0-meaning no pain to 10-meaning worst pain imaginable)0, 2, 4, 8, 16 and 24 hoursPostoperative 24 hours period. Patients' pain scores will be questioned at 0, 2, 4, 8, 16 and 24 hours.
Global recovery scoring system (patient satisfaction scale)- QoR-15The 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

Contacts

Primary ContactEralp Çevikkalp
eralpcevikkalp@hotmail.com+905054554875
Backup ContactEmre ULUSOY
emreulusoy36@gmail.com+905379492799

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026