superficial parasternal intercostal Plane block
ProcedureInjection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1
NCT Number: NCT05999721
In adult patients undergoing cardiac surgery, does adding an sPIP block to standard care compared to standard care alone result in a smaller decrease in PFTs?
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rabin Medical Center, Petah Tikva, Israel
Postoperative pulmonary complications are a significant concern after cardiac surgery, with post-sternotomy pain contributing to impaired pulmonary function and increased risk of these complications. Parasternal intercostal plane blocks have recently emerged as a promising analgesic option for cardiac surgery, but their impact on pulmonary function tests (PFTs) has yet to be evaluated.
This prospective, single-center, double-blind, randomized controlled trial will recruit 100 adult patients undergoing elective cardiac surgery. Baseline pulmonary function, including FEV1, FVC, and PEF, will be measured preoperatively and reassessed on the first postoperative day to evaluate the primary outcome: percentage change in PFT values. Secondary outcomes include pain scores, opioid consumption, incidence of postoperative pulmonary complications during hospitalization, duration of cardiothoracic intensive care and hospital stays, and 30-day mortality.
This study aims to determine whether adding a superficial parasternal intercostal plane (sPIP) block to standard care better preserves pulmonary function in adult patients undergoing elective cardiac surgery.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Criteria For Discontinuing (Postoperative Exclusion Criteria):
Injection of 60 mL of bupivacaine 0.25% and epinephrine 2.5 µg mL-1
Operating Room:
Anaesthesia will be induced using midazolam (0.1-0.15 mg kg-1), fentanyl (5-10 μg kg-1), and rocuronium (0.6-1.2 mg kg-1); then, after tracheal intubation, anaesthesia will be maintained using isoflurane at one MAC, along with continuous fentanyl (3-5 μg kg-1 h-1) and midazolam (20-50 μg kg-1 h-1). Additional boluses of fentanyl will be administered according to the anesthesiologist's discretion.
Cardiothoracic Intensive Care Unit:
Continuous fentanyl will be maintained until tracheal extubation. All patients will receive intravenous multimodal analgesic drugs around the clock, including paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain persists, rescue doses of either intravenous tramadol or morphine will be administered.
Cardiothoracic ward:
The analgesic protocol includes around-the-clock intravenous paracetamol 3 g day-1 and dipyrone 3 g day-1. If pain continues, rescue doses of oral oxycodone will be administered.
Time frame: Baseline (preoperative) and first postoperative day
Percentage change in FEV1 (measured in litres) from baseline to the first postoperative day.
Time frame: Baseline (preoperative) and first postoperative day
Percentage change in FVC (measured in litres) from baseline to the first postoperative day.
Time frame: Baseline (preoperative) and first postoperative day
Percentage change in PEF (measured in litres per second) from baseline to the first postoperative day.
Time frame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
Maximum pain NRS (0-10) recorded at various time intervals.
Time frame: 0-8 hours, 8-16 hours, 16-24 hours, 24-48 hours, and 48-72 hours postoperatively
Opioid consumption measured in MME at various time intervals postoperatively.
Time frame: 30 days
The incidence of postoperative pulmonary complications during current hospitalisation
Time frame: 30 days
The length of cardiothoracic intensive care unit and hospital stay
Time frame: 30 days
Thirty-day mortality
Contact information is provided by the study sponsor or research team.
Karam Azem, MD
CONTACT
Shai Fein, MD, MHA
CONTACT
Shai Fein
Other
The Effect of Superficial Parasternal Intercostal Plane Block on Pulmonary Function Tests After Cardiac Surgery (PIPACS Trial): a Prospective, Double-blind, Randomised Controlled Trial.
Acronym: PIPACS
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.
NCT07716566
Neurologic Manifestations, Pain
Istanbul, Turkey (Türkiye)
View Trial DetailsNCT07540104
Agnosia, Nervous System Diseases
Atakent, Samsun, Turkey (Türkiye)
View Trial DetailsNCT07458360
Arthritis, Joint Diseases
Konya, Turkey (Türkiye)
View Trial DetailsNCT07426731
Congenital Abnormalities, Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Istanbul, Turkey (Türkiye)
View Trial Details