Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorSaglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Serratus Posterior Superior Intercostal Plane Block With Bupivacaine

    Procedure/Surgery

    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.

  • Serratus Posterior Superior Intercostal Plane Block With Saline

    Procedure/Surgery

    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.

Treatment groups

90 Participants
are divided into 2 treatment groups
Group A: Serratus Posterior Superior Intercostal Plane Block with BupivacaineExperimental treatment 1 intervention
Group B: Serratus Posterior Superior Intercostal Plane Block with SalinePlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-hour cumulative opioid consumption

Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME).

Time frame
24 hours after surgery

Secondary outcomes

1

Postoperative pain intensity at rest (NRS)

Pain intensity at rest measured using the Numeric Rating Scale (0-10).

Time frame
4, 6, 12, and 24 hours after surgery
2

Postoperative pain during movement (NRS)

Pain intensity during coughing or deep breathing measured using the Numeric Rating Scale (0-10).

Time frame
4, 6, 12, and 24 hours after surgery
3

Time to first rescue analgesia

Time from the end of surgery to the first administration of rescue analgesia.

Time frame
Within 24 hours after surgery
4

Time to extubation

Time from the end of surgery to extubation.

Time frame
From the end of surgery until extubation, assessed up to 24 hours

Other outcomes

Sponsors and contacts

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