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

NCT ID: NCT06968065

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-17

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Pain, Postoperative Heart Surgery Analgesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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SAP + SIP Block Group

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.

Group Type EXPERIMENTAL

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

Intervention Type 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 Group

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.

Group Type ACTIVE_COMPARATOR

Local wound infiltration with bupivacaine

Intervention Type 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.

Interventions

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

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).

Intervention Type PROCEDURE

Local wound infiltration with bupivacaine

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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İstanbul Yeni Yüzyıl Üniversitesi

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Kolan International Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Selcuk Alver, MD

Role: CONTACT

+905435424234

Facility Contacts

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Ali Şefik Köprülü, MD

Role: primary

+905322677226

Other Identifiers

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2024101338

Identifier Type: -

Identifier Source: org_study_id

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