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SPSIP Block and Opioid Use After MICS

NCT07259824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-04-24

No results posted yet for this study

Summary

This prospective, randomized, controlled, single-center clinical study aims to evaluate the effectiveness of the Serratus Posterior Superior Intercostal Plane Block (SPSIPB) in perioperative pain management among patients undergoing minimally invasive cardiac surgery (MICS). A total of 50 patients undergoing MICS will be randomized into two groups: one receiving standard analgesia plus ultrasound-guided SPSIPB with 30 mL of 0.25% bupivacaine, and a control group receiving standard analgesia only. The primary outcome is total postoperative opioid consumption within 24 hours. Secondary outcomes include postoperative pain scores, extubation time, block-related complications, and recovery parameters such as early mobilization, oral intake, Modified radiological atelectasis score and Quality of Recovery-15 scores.

Conditions

  • Heart Valvular Disease
  • Minimally Invasive Cardiac Surgery
  • Postoperative Pain Management
  • Serratus Posterior Superior Intercostal Plane Block

Interventions

PROCEDURE

Serratus Posterior Superior Intercostal Plane Block (SPSIPB)

The SPSIPB will be performed under ultrasound guidance using an in-plane technique. The needle will be advanced into the fascial plane between the serratus posterior superior and intercostal muscles at the 2nd-3rd intercostal level, and 30 mL of 0.25% bupivacaine will be injected unilaterally on the surgical side. This procedure will be applied in addition to standard anesthesia and analgesia.

PROCEDURE

Sham Serratus Posterior Superior Intercostal Plane Block

The same ultrasound-guided procedure will be performed using identical technique and needle placement, but 30 mL of normal saline will be injected instead of local anesthetic. This sham block will be performed to maintain blinding, while all other anesthesia and analgesia protocols will be identical to the experimental group.

Sponsors & Collaborators

  • Ankara City Hospital Bilkent

    lead OTHER

Principal Investigators

  • Zeliha A Demir, M.D. · Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Professor of Aneshesiology

  • Aslıhan Aykut, M.D. · Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation, Associate Professor of Anesthesiology

  • Nisan Özsan, M.D. · Ankara Bilkent City Hospital, Department of Anesthesiology and Reanimation

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2026-04-15
Completion
2026-04-22

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07259824 on ClinicalTrials.gov