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NCT Number: NCT07588230

Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Fatma Acil

Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)

Location status: Recruiting

Location contact

Fatma Acil, M.D.

CONTACT

[email protected]

+905337225225

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Serratus Posterior Superior Intercostal Plane Block With Bupivacaine

Procedure

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.

Other names: SPSIP Block

Serratus Posterior Superior Intercostal Plane Block With Saline

Procedure

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 outcomes

  1. 24-hour cumulative opioid consumption

    Time frame: 24 hours after surgery

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

Secondary outcomes

  1. Postoperative pain intensity at rest (NRS)

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

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

  2. Postoperative pain during movement (NRS)

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

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

  3. Time to first rescue analgesia

    Time frame: Within 24 hours after surgery

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

  4. Time to extubation

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

    Time from the end of surgery to extubation.

  5. Length of intensive care unit stay

    Time frame: Through study completion, an average of 48 hours

    Duration of stay in the intensive care unit.

  6. Length of hospital stay

    Time frame: From date of admission until discharge, up to 30 days

    Total duration of hospitalization.

  7. Inspiratory Spirometry Test

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

    Inspiratory spirometry performance will be assessed using an incentive spirometer. Inspiratory capacity will be estimated based on the number of rising balls: 1 ball = 600 mL, 2 balls = 900 mL, and 3 balls = 1200 mL. The score ranges from a minimum of 1 ball to a maximum of 3 balls, with higher scores indicating better inspiratory function.

Study contacts

Contact information is provided by the study sponsor or research team.

Fatma Acil, M.D.

CONTACT

[email protected]

+905337225225

Sponsors and collaborators

Lead sponsor

Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 14, 2026
Registry last updated
May 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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