Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery

NCT07588230 | Recruiting

• 1 other identifier: 07/04/2026-132
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Heart Valve Disease; Postoperative Pain

Keywords

Cardiac Surgery; Postoperative Pain

Outcome Measures

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).

  24 hours after surgery

Secondary Outcomes (7)

• Postoperative pain intensity at rest (NRS)

  4, 6, 12, and 24 hours after surgery

• Postoperative pain during movement (NRS)

  4, 6, 12, and 24 hours after surgery

• Time to first rescue analgesia

  Within 24 hours after surgery

• Time to extubation

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

• Length of intensive care unit stay

  Through study completion, an average of 48 hours

Study Arms (2)

Serratus Posterior Superior Intercostal Plane Block with Bupivacaine

EXPERIMENTAL

Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with bupivacaine prior to surgery, in addition to standard general anesthesia and multimodal analgesia.

Procedure: Serratus Posterior Superior Intercostal Plane Block With Bupivacaine

Serratus Posterior Superior Intercostal Plane Block with Saline

PLACEBO COMPARATOR

Participants will receive an ultrasound-guided serratus posterior superior intercostal plane (SPSIP) block with normal saline under identical conditions, in addition to standard general anesthesia and multimodal analgesia.

Procedure: Serratus Posterior Superior Intercostal Plane Block With Saline

Interventions

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.

Also known as: SPSIP Block

Serratus Posterior Superior Intercostal Plane Block with Bupivacaine

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.

Serratus Posterior Superior Intercostal Plane Block with Saline

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital: lead

Study Sites (1)

Fatma Acil

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

RECRUITING

MeSH Terms

Conditions

Heart Valve Diseases; Pain, Postoperative

Interventions

Bupivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Fatma Acil, M.D.

  Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fatma Acil, M.D.

CONTACT

+905337225225; acilfatma@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers, investigators, and outcome assessors will be blinded to group allocation. Study solutions (bupivacaine or normal saline) will be prepared by an independent anesthesiologist according to the randomization sequence. The syringes will be identical in appearance, volume, and labeling. The anesthesiologist performing the block will not be aware of the syringe content.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned in a 1:1 ratio to receive either SPSIP block with bupivacaine or SPSIP block with saline. Both groups will undergo identical procedures under standardized conditions, and outcomes will be compared between parallel groups.

Study Record Dates

• First Submitted: May 5, 2026
• First Posted: May 14, 2026
• Study Start: May 16, 2026
• Primary Completion (Estimated): October 25, 2026
• Study Completion (Estimated): October 26, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Starting 6 months and ending 36 months following article publication.
• Access Criteria: Data will be available to researchers who provide a methodologically sound proposal. Proposals should be directed to acilfatma@gmail.com

Locations

TU (1)