An interventional study of Thoracic epidural analgesia and Erector spinae plane block in Pain, Postoperative and Respiratory Complication, sponsored by Karadeniz Technical University. Completed at 1 site in Turkey. Open to participants aged 20 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-25.
Sponsored by Karadeniz Technical University · Not applicable, Interventional, and Prevention
Postoperative pain negatively effects respiratory functions in open heart surgeries. The aim of the study is to compare the effects of thoracic epidural analgesia (TEA) and erector spinae plane block (ESPB) on postoperative pain and respiratory functions in patients undergoing open heart surgery with sternotomy
Thoracic epidural catheter was inserted to patients in Group T at the T4-T5 vertebra level before induction of general anesthesia. And then local anesthetic infusion was started until postoperative 48. hours.
Bilateral erector spinae plan block was applied with total 40 ml of local anesthetic solution to patients in Group E at the T4-T5 vertebra level before induction of general anesthesia.
The control group was infused with 1 mcg/kg/min fentanyl during the surgery. In the postoperative period, 1 g paracetamol was infused 4 times a day.
All patients underwent general anesthesia with the same method and medications.
Tramadol/diclofenac was administered to patients with a pain score (NRS) above 4. NRS and tidal volumes (TV) of the patients were measured at 0, 2, 6, 12, 24, 36 and 48. hours after extubation. Postoperative mechanical ventilation durations, intensive care unit and hospital stays, additional analgesic needs and respiratory complications of the patients were recorded.
5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.
This study's enrollment of 93 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.
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Exclusion Criteria:
Thoracic epidural analgesia have been started preoperatively and coninuoed until postoperative 48 hours
Procedure: Thoracic epidural analgesia
Erector spinae plane blockwas applied preoperatively
Procedure: Erector spinae plane block
Intravenous opioid analgesia was administered during the surgery
Thoracic epidural analgesia was started preoperatively and rest posoperative 48 hours
Erector spinae plane block was applied preoperatively using local anesthetic
Postoperative pain
Patients were asked about their pain levels. Rating done with VRS (Verbal Rating Scale). Pain levels were evaluated between 0 and 10 points. 0: No pain (the best)..... 10: Unbearable pain (the worst)
Time frame: Postoperative 48 hours
Respiratory functions
Oxygen requirement:If more than 4 l/min oxygen support via face mask is required to maintain peripheral oxygen saturation (SpO2) above 90%, it is defined as oxygen requirement. Tachypnea:more than 20/min Fever: more than 37 C celcius Non invasive mechanical ventilation requirement:To patients whose breathing is impaired after extubation (who have tachypnea and have SpO2 less than 90% despite receiving oxygen support of more than 4 l/min oxygen support via face mask)
Time frame: Postoperative 48 hours
Analgesic requirement. When the VRS was more than 4 points
diclofenac (75 mg), tramadol (50mg)
Time frame: Postoperative 48 hours
Intensive care and hospital stay
time for Intensive care and hospital (hours and days, respectively)
Time frame: postoperative 30 days
Plan to share: Yes — all collected IPD
Supporting information: Study protocol, Sap, Icf, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.
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Karadeniz Technical University