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

ConditionsPain, Postoperative Heart Surgery Analgesia

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

Sponsorİstanbul Yeni Yüzyıl Üniversitesi

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-75 years

Undergoing MICS with left-sided 4th-5th intercostal incision

ASA I-III

Informed consent provided

Disqualifiers

Coagulopathy or on anticoagulants

Allergy to local anesthetics or opioids

Local infection at block site

Pregnancy or lactation

Trial design

Design model

Single group

Treatments tested in this trial

Ultrasound-guided serratus anterior plane block and serratus-intercostal interfascial plane block with bupivacaine
Procedure/Surgery
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/Surgery
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.

Treatment groups

60 Participants

are divided into 2 treatment groups

Group A: SAP + SIP Block GroupExperimental treatment 1 intervention

Group B: Local Wound Infiltration GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

48 hours

Secondary outcomes

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

Time frame

0 to 72 hours postoperatively.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

İstanbul Yeni Yüzyıl Üniversitesi

Lead sponsor

Source ClinicalTrials.gov

Apply now