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Recruiting NCT06968065

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

No phase Interventional Pain, Postoperative Heart Surgery Analgesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine, Local wound infiltration with bupivacaine.
Who it may be relevant to
Registry conditions: Pain, Postoperative, Heart Surgery, Analgesia. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

  • Procedure 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).
  • 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.

Primary outcome measures

  • o Total opioid consumption (mcg of fentanyl and mg of tramadol) in the first 48 hours postoperatively. [Time frame: 48 hours]
Secondary outcome measures (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.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

Turkey (Türkiye) · 1 center
  • Kolan International Hospital — Istanbul

Identifiers

NCT: NCT06968065 · 2024101338

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗