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

NCT ID: NCT07232992

Last Updated: 2025-11-19

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-15
• Study Completion Date: 2026-04-15

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Group SPSIPB

It will be administered bilaterally before the induction of general anesthesia.

Group Type: ACTIVE_COMPARATOR

SPSIPB blcok

Intervention Type: 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

Intervention Type: 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.

Group Control

Parasternal block and local infiltration at the drain insertion site.

Group Type: ACTIVE_COMPARATOR

Parasternal blocks

Intervention Type: 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

Intervention Type: OTHER

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

Interventions

SPSIPB blcok

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.

Intervention Type: OTHER

Parasternal blocks

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.

Intervention Type: OTHER

Local Infiltration

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

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Emre ULUSOY

UNKNOWN

Sponsor Role: collaborator

Bursa City Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

eralp çevikkalp

assoc prof

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Eralp Çevikkalp

Role: CONTACT

eralpcevikkalp@hotmail.com

+905054554875

Emre ULUSOY

Role: CONTACT

emreulusoy36@gmail.com

+905379492799

References

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.

Reference Type: BACKGROUND

PMID: 39103782 (View on PubMed)

Other Identifiers

Bursa City Hospital 003

Identifier Type: -

Identifier Source: org_study_id