An observational study in Postoperative Pain and Extubation Time, sponsored by Samsun University. Not yet recruiting at 1 site in Turkey (Türkiye). Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Samsun University · Observational
"Postoperative pain constitutes a major recovery challenge in patients undergoing open-heart surgery with median sternotomy and chest tube insertion (subxiphoid/intercostal). This study aimed to evaluate the effect of parasternal and rectointercostal block administration-performed to achieve pain control and reduce the postoperative analgesic burden-on patient postoperative recovery and extubation time."
"Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and increased pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and impaired intestinal motility.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the duration of intensive care unit stay.
Median sternotomy performed in open-heart surgery causes severe anterior chest wall pain in the postoperative period. This pain leads to inadequate inspiration, suppression of the cough reflex, atelectasis, and an increase in pulmonary complications. On the other hand, traditionally used high-dose opioid-based analgesia regimens delay the extubation process by causing respiratory depression, nausea, sedation, and gastrointestinal motility disorders.
In current cardiac anesthesia practice, the primary goal is to reduce opioid consumption through multimodal analgesia approaches, enable early extubation (fast-track cardiac anesthesia), and shorten the length of stay in the intensive care unit.
Parasternal block (parasternal intercostal block or pectoral/parasternal fascial plane blocks) targets the anterior cutaneous branches of T2-T6 spinal nerves, providing potent analgesia around the sternum and internal mammary area. Studies in the literature demonstrate that bilateral parasternal block performed under ultrasonography (USG) guidance significantly controls somatic pain related to sternotomy incision.
Rectointercostal fascial plane block blocks the anterior and lateral cutaneous branches of T6-T9 intercostal nerves. It provides somatic analgesia in the epigastric region, subxiphoid incision lines, and the lower border of the anterior abdominal/chest wall. It specifically blocks the sharp pain at the subxiphoid chest tube (drain) insertion sites-which are not covered by the parasternal block applied for median sternotomy in open-heart surgery-and the discomfort during tube removal.
Opioid Sparing and Pulmonary Functions: Randomized controlled trials have reported that blocks administered intraoperatively or at the end of surgery reduce total postoperative 24-hour opioid (fentanyl, morphine, tramadol) consumption by 30% to 50%. Decreased opioid requirement improves the recovery quality of patients by minimizing systemic side effects.
Extubation Time: Optimization of analgesia ensures the maintenance of patient chest wall compliance and tidal volume. Literature shows that patients receiving blocks reach weaning criteria faster once normothermia and hemodynamic stability are achieved, and their mean extubation times are significantly shorter compared to control groups.
Although prospective studies exist in the literature, retrospective cohort analyses investigating the impact of clinical routine practice on extubation times and reflecting real-world data are needed.
For this purpose, patients who underwent open-heart surgery in our clinic during a 2-year period (2024-2025) will be screened to investigate the effect of block applications on extubation times.
"Patients' age, sex, BMI, presence of comorbidities, ejection fraction, duration of surgery, cardiopulmonary bypass time, cross-clamp time, extubation time, administration of rescue analgesia, Visual Analog Scale (VAS) score at extubation, EuroSCORE II, and length of intensive care unit (ICU) stay will be recorded.
The primary endpoint was determined as meeting the weaning criteria and achieving successful extubation.
The secondary endpoint was determined as discharge from the intensive care unit
5,259 studies on the registry are indexed under Pain, Postoperative; 1,163 are open to participants now.
This study's planned enrollment of 40 is below the median of 101 across 624 observational studies indexed under Pain, Postoperative.
Browse Pain, Postoperative studies →Samsun University is the lead sponsor of 89 studies on the registry; 22 are open to participants now.
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"Patients who underwent open-heart surgery in our clinic during the period of 2024-2025
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Exclusion Criteria:
"Patients who underwent ultrasound-guided parasternal and rectointercostal block for postoperative analgesia.
"Patients followed up with routine postoperative analgesics without receiving any nerve block."
POSTOPERATİVE EXTUBATİON TİME
The primary result measure is the extubation period recorded as the time from the patient's arrival at the intensive care unit to successful extubation.
Time frame: Within the first 24-48 hours postoperatively
Visual Analog Scale (VAS) Pain Score at 30 Minutes Post-Extubation
"Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 30 minutes following tracheal extubation
Time frame: postoperative 30th minute
Visual Analog Scale (VAS) Pain Score at 2 Hours Post-Extubation
Assessment of postoperative pain intensity using the Visual Analog Scale (ranging from 0 to 10) 2 hours following tracheal extubation.
Time frame: postoperative 2nd hour
Plan to share: Undecided
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Samsun University