NCT07420712

Brief Summary

This prospective randomized controlled trial aims to evaluate the effectiveness of the serratus posterior superior intercostal plane block (SPSIPB) as part of a multimodal analgesia strategy in patients undergoing minimally invasive cardiac surgery. Sixty adult ASA III patients scheduled for minimally invasive coronary artery bypass surgery will be randomly assigned to either an SPSIPB group or a control group receiving standard analgesic management without a plane block. The primary outcome is postoperative opioid (tramadol) consumption, while secondary outcomes include intraoperative remifentanil consumption, pain scores at rest and during coughing, time to first rescue analgesia, time to extubation, and lengths of intensive care unit and hospital stay. All patients will receive standardized general anesthesia and postoperative patient-controlled analgesia. Pain intensity will be assessed using the Numeric Rating Scale at predefined postoperative intervals. Postoperative complications such as nausea, vomiting, and atelectasis will be recorded. This study aims to determine whether SPSIPB provides effective opioid-sparing analgesia and improves postoperative recovery parameters in minimally invasive cardiac surgery.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Jul 2025

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress89%
Jul 2025Jul 2026

Study Start

First participant enrolled

July 1, 2025

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 4, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 19, 2026

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2026

Last Updated

February 19, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 4, 2026

Last Update Submit

February 11, 2026

Conditions

Keywords

Serratus posterior superior intercostal plane blockPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative Opioid Consumption

    Total postoperative opioid consumption measured as cumulative tramadol dose administered via patient-controlled analgesia during the first 24 postoperative hours.

    Within the first 24 hours after surgery

Secondary Outcomes (5)

  • Intraoperative Opioid Consumption

    During surgery

  • Postoperative Pain Intensity (NRS)

    At 30 minutes, and at 1, 6, 12, 18, and 24 hours after surgery (within the first 24 postoperative hours).

  • 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.

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 BlockDrug: BupivacaineDevice: 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 was administered as the local anesthetic for the block.

SPSIPB Group

Ultrasound guidance was used for block placement.

SPSIPB Group

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

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults aged 18 years or older
  • American Society of Anesthesiologists (ASA) physical status 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 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kosuyolu High Specialization Training and Research Hospital

Istanbul, 34870, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

AgnosiaPain, Postoperative

Interventions

BupivacaineUltrasonography

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPostoperative ComplicationsPathologic ProcessesPain

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Mustafa Burgaç, himself

    mustafaburgac@outlook.com

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mustafa Burgaç, himself

CONTACT

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
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.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Specialist physician

Study Record Dates

First Submitted

February 4, 2026

First Posted

February 19, 2026

Study Start

July 1, 2025

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Last Updated

February 19, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data generated and analyzed during this study will not be made publicly available. However, de-identified individual participant data may be shared by the corresponding author upon reasonable request, provided that the request is methodologically sound and complies with institutional and ethical regulations.

Locations