Ignite Creation Date:
2025-12-24 @ 11:59 AM
Ignite Modification Date:
2025-12-29 @ 12:59 PM
Study NCT ID:
NCT07287761
Status:
RECRUITING
Last Update Posted:
2025-12-17
First Post:
2025-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in Postoperative Pain Management After Coronary Artery Bypass Grafting
Sponsor:
Ankara Education and Research Hospital
Organization:
Study Overview
Official Title:
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in Postoperative Pain Management After Coronary Artery Bypass Grafting: A Prospective, Observational Study
Status:
RECRUITING
Status Verified Date:
2025-12
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:
Coronary Artery Bypass Grafting (CABG) is a common surgical procedure for ischemic heart disease, but it often leads to severe acute and chronic postoperative pain, which can delay recovery and reduce patient comfort. Effective pain management is crucial to prevent pulmonary complications and long hospital stays. Peripheral nerve blocks are increasingly used to reduce opioid consumption and improve patient satisfaction after major surgery.
This prospective, observational study aims to compare the effectiveness and safety of two different regional anesthesia techniques, the Erector Spinae Plane Block (ESPB) and the Serratus Posterior Superior Intercostal Plane Block (SPSIPB), in managing postoperative pain in patients undergoing CABG via median sternotomy.
Patients aged 18-80 years, classified as ASA II-III, who are scheduled for elective CABG will be included. The choice of block technique (ESPB or SPSIPB) will be determined by the operating anesthesiologist based on the visibility of anatomical structures (transverse processes) under ultrasound guidance. All patients will receive the same general anesthesia and be managed postoperatively with Intravenous Patient-Controlled Analgesia (PCA).
The main goal is to determine which block provides optimal pain control, measured by the time to first rescue analgesia and pain scores (NRS) at various time points after extubation. Secondary outcomes include intraoperative opioid consumption, total PCA usage, extubation time, and the incidence of opioid-related side effects. The findings will help optimize pain protocols for cardiac surgery patients.
This prospective, observational study aims to compare the effectiveness and safety of two different regional anesthesia techniques, the Erector Spinae Plane Block (ESPB) and the Serratus Posterior Superior Intercostal Plane Block (SPSIPB), in managing postoperative pain in patients undergoing CABG via median sternotomy.
Patients aged 18-80 years, classified as ASA II-III, who are scheduled for elective CABG will be included. The choice of block technique (ESPB or SPSIPB) will be determined by the operating anesthesiologist based on the visibility of anatomical structures (transverse processes) under ultrasound guidance. All patients will receive the same general anesthesia and be managed postoperatively with Intravenous Patient-Controlled Analgesia (PCA).
The main goal is to determine which block provides optimal pain control, measured by the time to first rescue analgesia and pain scores (NRS) at various time points after extubation. Secondary outcomes include intraoperative opioid consumption, total PCA usage, extubation time, and the incidence of opioid-related side effects. The findings will help optimize pain protocols for cardiac surgery patients.
Detailed Description:
This is a single-center, prospective, observational study conducted at the University of Health Sciences Ankara Training and Research Hospital. The primary clinical challenge addressed is the intense postoperative pain following median sternotomy for Coronary Artery Bypass Grafting (CABG), which requires multimodal analgesia. The use of ultrasound-guided interfascial plane blocks has gained popularity due to their ease of application and lower complication rates compared to traditional methods.
Rationale for Comparison:
The Erector Spinae Plane Block (ESPB) has proven efficacy in thoracic and abdominal procedures. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is being investigated as a potential alternative, targeting a broader area to manage pain in cardiac surgery. The study aims to provide clinical evidence regarding which of these two specific regional techniques offers superior postoperative pain control in this patient population.
Procedure Detail (Specific to Observation):
The selection of the block type (ESPB or SPSIPB) for the patient is determined intraoperatively by the experienced anesthesiologist based on the quality of the ultrasound image (visibility of the transverse processes) to ensure the most anatomically suitable block is performed.
Anesthesia Protocol (Standardized):
All enrolled patients (ASA II-III) will receive the same general anesthesia protocol (Thiopental, Fentanyl, Rocuronium for induction; Sevoflurane for maintenance). The regional block will be administered by a single experienced anesthesiologist under the supervision of the responsible investigator, using a bilateral injection of 30 mL of 0.25% Bupivacaine for both techniques. Postoperative analgesia will be managed using a standardized Intravenous Patient-Controlled Analgesia (PCA) device, set at a 3mg/ml concentration, with a 24mg bolus dose and a 20-minute lockout interval.
Rationale for Comparison:
The Erector Spinae Plane Block (ESPB) has proven efficacy in thoracic and abdominal procedures. The Serratus Posterior Superior Intercostal Plane Block (SPSIPB) is being investigated as a potential alternative, targeting a broader area to manage pain in cardiac surgery. The study aims to provide clinical evidence regarding which of these two specific regional techniques offers superior postoperative pain control in this patient population.
Procedure Detail (Specific to Observation):
The selection of the block type (ESPB or SPSIPB) for the patient is determined intraoperatively by the experienced anesthesiologist based on the quality of the ultrasound image (visibility of the transverse processes) to ensure the most anatomically suitable block is performed.
Anesthesia Protocol (Standardized):
All enrolled patients (ASA II-III) will receive the same general anesthesia protocol (Thiopental, Fentanyl, Rocuronium for induction; Sevoflurane for maintenance). The regional block will be administered by a single experienced anesthesiologist under the supervision of the responsible investigator, using a bilateral injection of 30 mL of 0.25% Bupivacaine for both techniques. Postoperative analgesia will be managed using a standardized Intravenous Patient-Controlled Analgesia (PCA) device, set at a 3mg/ml concentration, with a 24mg bolus dose and a 20-minute lockout interval.
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?: