Serratus Posterior Superior Plane Block in Minimally Invasive Cardiac Surgery

NCT07420712 | Completed

• 1 other identifier: 2025/12/1164
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective randomized controlled trial aimed to evaluate the efficacy of serratus posterior superior intercostal plane block (SPSIPB) as a component of a multimodal analgesia strategy for postoperative pain control, opioid consumption, and hemodynamic response in patients undergoing mini-thoracotomy cardiac surgery. The study was planned to include a total of 60 patients, with 30 patients in each group. Patients with ASA physical status I-III scheduled for elective mini-thoracotomy cardiac surgery (coronary artery bypass grafting, valve replacement, atrial septal defect closure, or beating-heart bypass) will be randomized to the SPSIPB group or a control group receiving standard analgesic management without any regional block. The primary outcome is the resting Numeric Rating Scale (NRS) pain score at 1 hour postoperatively. Secondary outcomes include resting and movement (passive shoulder flexion) NRS pain scores at 1, 4, 8, 16, and 24 hours, cumulative 24-hour tramadol consumption, proportion of patients requiring rescue analgesia, intraoperative remifentanil consumption, systolic blood pressure change at incision, incidence of postoperative nausea and vomiting (PONV), patient satisfaction (5-point Likert scale), time to extubation, and intensive care unit length of stay.

Conditions

Analgesia

Keywords

Serratus posterior superior intercostal plane block; Postoperative pain

Outcome Measures

Primary Outcomes (1)

• Resting NRS pain score at 1 hour postoperatively

  "Pain intensity will be assessed using the Numeric Rating Scale (NRS; 0 = no pain, 10 = worst imaginable pain) at postoperative 1, 4, 8, 16, and 24 hours, both at rest and during movement (passive shoulder flexion)."

  At 1, 6, 12, 18, and 24 hours after surgery (within the first 24 postoperative hours).

Secondary Outcomes (10)

• Intraoperative Opioid Consumption

  During surgery

• Time to First Rescue Analgesia

  From the end of surgery to the administration of the first rescue analgesic, assessed within the first 24 postoperative hours

• Time to Extubation

  From completion of surgery to successful tracheal extubation, assessed during the intraoperative and immediate postoperative period.

• Length of Stay in the Intensive Care Unit (ICU)

  From admission to the intensive care unit until ICU discharge, assessed up to 30 days postoperatively.

• Postoperative Opioid Consumption

  24 hours after surgery

Study Arms (2)

SPSIPB Group

EXPERIMENTAL

Patients in this arm receive an ultrasound-guided serratus posterior superior intercostal plane block in addition to standard general anesthesia and multimodal postoperative analgesia as part of the perioperative pain management strategy.

Procedure: Serratus Posterior Superior Intercostal Plane Block; Drug: Bupivacaine; Device: Ultrasound

Control Group

NO INTERVENTION

Patients in this arm receive standard general anesthesia and multimodal postoperative analgesia without the use of any regional plane block for perioperative pain management.

Interventions

Bupivacaine DRUG

Bupivacaine was administered as the local anesthetic for the block.

SPSIPB Group

Ultrasound DEVICE

Ultrasound guidance was used for block placement.

SPSIPB Group

Serratus Posterior Superior Intercostal Plane Block PROCEDURE

The serratus posterior superior intercostal plane block is performed under ultrasound guidance before surgery, with the patient in the lateral position. After identification of the third rib and the serratus posterior superior muscle, a local anesthetic solution is injected between the muscle and the rib to provide thoracic wall analgesia as part of a multimodal pain management strategy.

SPSIPB Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 years or older
• American Society of Anesthesiologists (ASA) physical status I - III
• Scheduled for elective minimally invasive coronary artery bypass surgery
• Ability to understand the study procedures and provide written informed consent

You may not qualify if:

• Age under 18 years
• ASA physical status other than I - III
• Pregnancy
• Emergency surgery
• History of trauma within the previous 24 hours
• Neurological disorders affecting consciousness or decision-making capacity
• Psychiatric disorders affecting decision-making capacity or cooperation
• Known allergy to local anesthetic agents
• Infection or skin disease at the block injection site
• Body mass index greater than 35 kg/m²
• Body weight less than 42 kg
• Coagulation disorders (international normalized ratio \>1.25, activated partial thromboplastin time \>35 seconds, or platelet count \<100,000/µL)

Sponsors & Collaborators

• Kartal Kosuyolu High Speciality Training and Research Hospital: lead

Study Sites (1)

Kosuyolu High Specialization Training and Research Hospital

Istanbul, 34870, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Bupivacaine; Ultrasonography

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Mustafa Burgaç, himself

  mustafaburgac@outlook.com

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Postoperative pain assessments, opioid consumption data, and outcome evaluations are performed by an investigator who is blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist physician

Model Details: Katılımcılar, ultrason eşliğinde serratus posterior superior interkostal plan bloğu uygulanan grup veya bölgesel plan blok uygulanmadan standart multimodal analjezi alan kontrol grubuna rastgele atanacaktır. Sonuçlar iki paralel grup arasında karşılaştırılacaktır.

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 19, 2026
• Study Start: February 20, 2026
• Primary Completion: September 1, 2026
• Study Completion: September 1, 2026
• Last Updated: September 11, 2026

Record last verified: 2026-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)