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

NCT06968065 | Recruiting

• 1 other identifier: 2024101338
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain, Postoperative; Heart Surgery; Analgesia

Keywords

Pain, Postoperative; Heart Surgery, Minimally Invasive; Analgesia; Bupivacaine; Opioid-Related Disorders

Outcome Measures

Primary Outcomes (1)

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

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

  48 hours

Secondary Outcomes (1)

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

  0 to 72 hours postoperatively.

Study Arms (2)

SAP + SIP Block Group

EXPERIMENTAL

Participants in this arm will receive a combination of ultrasound-guided serratus anterior plane (SAP) block and serratus-intercostal interfascial plane (SIP) block. The SAP block will be performed using 30 mL of 0.25% bupivacaine, and the SIP block will use 10 mL of 0.25% bupivacaine. Both blocks will be administered after surgery but before emergence from anesthesia.

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

Local Wound Infiltration Group

ACTIVE COMPARATOR

Participants in this arm will receive local wound infiltration (LWI) consisting of 40 mL of 0.25% bupivacaine. The infiltration will be applied to the surgical and drain sites after surgery.

Procedure: Local wound infiltration with bupivacaine

Interventions

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).

SAP + SIP Block Group

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.

Local Wound Infiltration Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• İstanbul Yeni Yüzyıl Üniversitesi: lead

Study Sites (1)

Kolan International Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative; Agnosia; Opioid-Related Disorders

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

Selcuk Alver, MD

CONTACT

+905435424234; alverselcuk@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2025
• First Posted: May 13, 2025
• Study Start: October 17, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: May 13, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)