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

B

Bursa City Hospital

Status

Not yet enrolling

Conditions

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

Treatments

Other: Local Infiltration
Other: SPSIPB blcok
Other: Parasternal blocks

Study type

Interventional

Funder types

Other

Identifiers

NCT07232992
Bursa City Hospital 003

Details and patient eligibility

About

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.

Full 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.

Enrollment

70 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Group SPSIPB
Active Comparator group
Description:
It will be administered bilaterally before the induction of general anesthesia.
Treatment:
Other: Parasternal blocks
Other: SPSIPB blcok
Group Control
Active Comparator group
Description:
Parasternal block and local infiltration at the drain insertion site.
Treatment:
Other: Parasternal blocks
Other: Local Infiltration

Trial contacts and locations

0

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Central trial contact

Emre ULUSOY; Eralp Çevikkalp

Data sourced from clinicaltrials.gov

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