Actively Recruiting
Preoperative Serratus Posterior Superior Intercostal Plane Block for Analgesia and Opioid Sparing in Minimally Invasive Cardiac Valve Surgery via Mini-Thoracotomy: A Randomized, Double-Blind, Placebo-Controlled Trial
Led by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital · Updated on 2026-05-19
90
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the analgesic effect of the serratus posterior superior intercostal plane (SPSIP) block in patients undergoing minimally invasive cardiac valve surgery through a mini-thoracotomy. This prospective, randomized, double-blind, placebo-controlled trial aims to assess whether the SPSIP block can reduce postoperative pain and opioid use, which is important for improving recovery and respiratory function after thoracic cardiac surgery. Participants will be randomly assigned to one of two groups. One group receives an ultrasound-guided SPSIP block with 30 mL of 0.25% bupivacaine before surgery, along with standard general anesthesia and postoperative multimodal pain management. The other group receives a placebo block with 30 mL of normal saline under the same conditions. Both patients and outcome assessors are blinded to treatment allocation. During the study, participants will be monitored for opioid consumption over 24 hours after surgery, pain intensity at rest and during movement at multiple time points, time to first rescue pain medication, time to extubation, and length of intensive care and hospital stay. Lung function will be assessed using an Inspiratory Spirometry Test after surgery. The total participation includes the surgical period and up to 30 days of follow-up for hospital discharge outcomes.
CONDITIONS
Brief Title
Serratus Posterior Superior Intercostal Plane Block in Minimally Invasive Cardiac Surgery
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- Age over 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Day of surgery
Participants receive an ultrasound-guided serratus posterior superior intercostal plane block with either bupivacaine or saline prior to minimally invasive cardiac valve surgery, along with standard general anesthesia and postoperative multimodal analgesia.
1 visit (in-person)
Duration - Up to 30 days after surgery
Participants are monitored for pain, opioid consumption, respiratory function, and recovery during the first 24 hours after surgery and up to hospital discharge.
Multiple assessments at 4, 6, 12, and 24 hours after surgery; follow-up until discharge
Trial Site Locations
Total: 1 location
1
Fatma Acil
Diyarbakır, Outside of the US, Turkey (Türkiye), 21070
Actively Recruiting
Research Team
F
Fatma Acil, M.D.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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