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NCT Number: NCT06968065

Comparison of Ultrasound-Guided Serratus Combination Plane Blocks and Local Wound Infiltration for Postoperative Analgesia Management in Minimally Invasive Cardiac Surgery (MICS)

This randomized, prospective, single-blinded study aims to compare the efficacy of ultrasound-guided serratus anterior plane (SAP) block combined with serratus-intercostal interfascial plane (SIP) block versus local wound infiltration (LWI) for postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS). The primary outcome is total perioperative and postoperative opioid consumption. Secondary outcomes include postoperative pain scores (NRS), opioid-related side effects, block-related complications, and ICU stay duration.

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Key information

Conditions

Pain, Postoperative Agnosia Analgesia Chemically-Induced Disorders Heart Surgery Mental Disorders Narcotic-Related Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Opioid-Related Disorders Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms Substance-Related Disorders

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kolan International Hospital

Istanbul, Turkey (Türkiye)

Location status: Recruiting

Location contact

Ali Şefik Köprülü, MD

CONTACT

[email protected]

+905322677226

About this study

Minimally invasive cardiac surgery (MICS) has gained popularity due to reduced surgical trauma and faster recovery. However, postoperative pain management remains a challenge. This study evaluates the analgesic effectiveness of combining two interfascial plane blocks-SAP and SIP-under ultrasound guidance, compared to traditional local wound infiltration. A total of 60 patients scheduled for MICS with cardiopulmonary bypass will be randomized into two groups (SAP+SIP vs LWI). Pain scores, opioid usage, and complications will be recorded at predetermined intervals up to 72 hours postoperatively.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-75 years
  • Undergoing MICS with left-sided 4th-5th intercostal incision
  • ASA I-III
  • Informed consent provided

Exclusion criteria

  • Coagulopathy or on anticoagulants
  • Allergy to local anesthetics or opioids
  • Local infection at block site
  • Pregnancy or lactation
  • Bilateral thoracic incisions
  • Refusal to participate

Treatment and study plan

Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine

Procedure

Participants will receive an ultrasound-guided serratus anterior plane (SAP) block using 30 mL of 0.25% bupivacaine combined with a serratus-intercostal interfascial plane (SIP) block using 10 mL of 0.25% bupivacaine. Both blocks will be administered after surgery but before emergence from anesthesia. This combination targets multiple interfascial planes to enhance postoperative analgesia in patients undergoing minimally invasive cardiac surgery (MICS).

Local wound infiltration with bupivacaine

Procedure

Participants will receive local wound infiltration with 40 mL of 0.25% bupivacaine applied to the surgical and drain sites following surgery. This approach represents a standard method for managing postoperative pain in MICS patients and serves as the active comparator.

Primary outcomes

  1. o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively.

    Time frame: 48 hours

    The cumulative perioperative and postoperative opioid consumption measured in micrograms of fentanyl and milligrams of tramadol administered during the first 48 hours after surgery.

Secondary outcomes

  1. NRS pain scores (static and dynamic) at 0, 2, 4, 8, 16, 24, 48, and 72 hours postoperatively.

    Time frame: 0 to 72 hours postoperatively.

    Pain intensity will be assessed using the Numeric Rating Scale (NRS) at rest and during movement at predefined postoperative time points (0, 2, 4, 8, 16, 24, 48, and 72 hours).

Study contacts

Contact information is provided by the study sponsor or research team.

Selcuk Alver, MD

CONTACT

[email protected]

+905435424234

Sponsors and collaborators

Lead sponsor

İstanbul Yeni Yüzyıl Üniversitesi

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 13, 2025
Registry last updated
May 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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