Fatma Acil
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07588230
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Interventional
Not applicable
Diyarbakır, Outside of the US, 21070, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
Time frame: 24 hours after surgery
Total opioid consumption within the first 24 hours after surgery, expressed as intravenous morphine milligram equivalents (IV-MME).
Time frame: 4, 6, 12, and 24 hours after surgery
Pain intensity at rest measured using the Numeric Rating Scale (0-10).
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).
Time frame: Within 24 hours after surgery
Time from the end of surgery to the first administration of rescue analgesia.
Time frame: From the end of surgery until extubation, assessed up to 24 hours
Time from the end of surgery to extubation.
Time frame: Through study completion, an average of 48 hours
Duration of stay in the intensive care unit.
Time frame: From date of admission until discharge, up to 30 days
Total duration of hospitalization.
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.
Contact information is provided by the study sponsor or research team.
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
Other
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
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.
Published trials that share one or more normalized conditions with this study.
NCT06027788
Acute Kidney Injury, Arterial Occlusive Diseases
North Little Rock, Arkansas, United States
View Trial DetailsNCT07511673
Cardiovascular Diseases, Endocarditis
Gothenburg, Sweden
View Trial DetailsNCT06581471
Cardiovascular Diseases, Heart Diseases
Aalst, Belgium
View Trial DetailsNCT07267117
Aortic Valve Disease, Aortic Valve Insufficiency
Fuzhou, Fujian, China
View Trial Details