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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06968065
Enrollment
60
Registered
2025-05-13
Start date
2024-10-17
Completion date
2025-06-30
Last updated
2025-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Heart Surgery, Pain, Postoperative

Keywords

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

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.

Detailed description

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.

Interventions

PROCEDUREUltrasound-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).

PROCEDURELocal 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.

Sponsors

İstanbul Yeni Yüzyıl Üniversitesi
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively.48 hoursThe cumulative perioperative and postoperative opioid consumption measured in micrograms of fentanyl and milligrams of tramadol administered during the first 48 hours after surgery.

Secondary

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

Countries

Turkey (Türkiye)

Contacts

Primary ContactSelcuk Alver, MD
alverselcuk@gmail.com+905435424234

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026