Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-05 @ 3:47 PM
Study NCT ID:
NCT06098859
Status:
COMPLETED
Last Update Posted:
2023-10-25
First Post:
2023-10-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain in Open Heart Surgeries
Sponsor:
Karadeniz Technical University
Organization:
Study Overview
Official Title:
Comparison of the Effects of Thoracic Epidural Analgesia and Bilateral Erector Spinae Plane Block on Postoperative Pain and Respiratory Fonctions in Open Heart Surgeries''
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: