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Recruiting NCT07588230

Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery

No phase Interventional Heart Valve Disease Postoperative Pain

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: Serratus Posterior Superior Intercostal Plane Block With Bupivacaine, Serratus Posterior Superior Intercostal Plane Block With Saline.
Who it may be relevant to
Registry conditions: Heart Valve Disease, Postoperative Pain. 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 →

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Official title

Preoperative Serratus Posterior Superior Intercostal Plane Block for Analgesia and Opioid Sparing in Patients Undergoing Minimally Invasive Cardiac Valve Surgery Via Mini-Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled Trial

Overview

This randomized, double-blind, placebo-controlled study aims to evaluate the effect of the serratus posterior superior intercostal plane (SPSIP) block on postoperative pain and opioid consumption in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy.

Detailed description

This study is a prospective, randomized, double-blind, placebo-controlled clinical trial designed to evaluate the analgesic efficacy of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery via mini-thoracotomy. Postoperative pain following thoracic cardiac surgery may impair respiratory function and delay recovery, making effective analgesia essential.

Participants will be randomly assigned to receive an ultrasound-guided SPSIP block with either bupivacaine or normal saline under identical conditions. All patients will receive standardized general anesthesia and postoperative multimodal analgesia. Blinding will be ensured for patients and outcome assessors.

The study aims to determine whether SPSIP block with local anesthetic reduces postoperative opioid consumption and improves pain control compared to placebo.

Interventions

  • Procedure Serratus Posterior Superior Intercostal Plane Block With Bupivacaine
    Participants in this group will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block prior to surgery using 30 mL of 0.25% bupivacaine, in addition to standard general anesthesia and multimodal analgesia.
  • Procedure Serratus Posterior Superior Intercostal Plane Block With Saline
    Participants in this group will receive an ultrasound-guided placebo block using 30 mL of normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.

Primary outcome measures

  • 24-hour cumulative opioid consumption [Time frame: 24 hours after surgery]
Secondary outcome measures (7)
  • Postoperative pain intensity at rest (NRS) [Time frame: 4, 6, 12, and 24 hours after surgery]
  • Postoperative pain during movement (NRS) [Time frame: 4, 6, 12, and 24 hours after surgery]
  • Time to first rescue analgesia [Time frame: Within 24 hours after surgery]
  • Time to extubation [Time frame: From the end of surgery until extubation, assessed up to 24 hours]
  • Length of intensive care unit stay [Time frame: Through study completion, an average of 48 hours]
  • Length of hospital stay [Time frame: From date of admission until discharge, up to 30 days]
  • Inspiratory Spirometry Test [Time frame: 4, 6, 12, and 24 hours after surgery]

Eligibility criteria

Inclusion criteria

  • Adult patients aged 18-75 years
  • ASA physical status I-III
  • Scheduled for elective minimally invasive cardiac valve surgery via mini-thoracotomy
  • Able to understand and use the Numeric Rating Scale (NRS)
  • Provided written informed consent

Exclusion criteria

  • Age >75 years
  • Known allergy or hypersensitivity to local anesthetics (e.g., bupivacaine)
  • Coagulopathy or ongoing anticoagulant therapy that cannot be discontinued
  • Infection at the planned block site
  • Chronic opioid use or chronic pain conditions
  • Severe pulmonary disease affecting respiratory assessment
  • Neurological or psychiatric disorders interfering with pain assessment
  • Emergency surgery
  • Pregnancy or breastfeeding
  • 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
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Fatma Acil — Diyarbakır

Identifiers

NCT: NCT07588230 · 07/04/2026-132

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗