- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07287761
Comparison of Erector Spinae Plane Block and Serratus Posterior Superior Intercostal Plane Block in Postoperative Pain Management After Coronary Artery Bypass Grafting
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
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.
Study Overview
Status
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Abdullah KONAN, M.D
- Phone Number: 3175 +903125953000
- Email: drkonan44@gmail.com
Study Contact Backup
- Name: Suna AKIN TAKMAZ, M.D
Study Locations
-
-
Altındag
-
Ankara, Altındag, Turkey (Türkiye), 06230
- Recruiting
- Ankara Training and Research Hospital
-
Contact:
- Abdullah KONAN, M.D
- Phone Number: 3176 +90 312 595 3000
- Email: drkonan44@gmail.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients scheduled for elective Coronary Artery Bypass Grafting (CABG) via median sternotomy.
- Age between 18 and 80 years.
- Classification of American Society of Anesthesiologists (ASA) Physical Status Class II or III.
- Patients who provide written and verbal informed consent to participate in the study.
Exclusion Criteria:
- Patients who do not provide consent.
- Age older than 80 years or ASA Physical Status Class > III.
- Patients who do not understand the Numerical Rating Scale (NRS) or have communication difficulties.
- Patients with a known history of coagulation disorders or bleeding disorders.
- Patients with skin infection at the site of peripheral nerve block application.
- Patients with Morbid Obesity (Body Mass Index BMI>35 kg/m2).
- Patients with chronic pain, opioid or substance dependence, or who use chronic analgesics.
- Patients with known allergy to local anesthetics.
- Patients with liver or kidney function disorders.
- Patients with a history of previous median sternotomy operation.
- Patients undergoing emergency surgery.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
|
ESPB Group
Erector Spinae Plane Block (ESPB) with Bupivacaine
|
|
SPSIPB Group
Serratus Posterior Superior Intercostal Plane Block (SPSIPB) with Bupivacaine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Total Opioid Consumption in the Perioperative Period
Time Frame: Up to 24 hours post-extubation
|
The cumulative dose of all opioids administered (Intraoperative Fentanyl and Post-Extubation Tramadol via PCA and rescue doses of Morphine) will be calculated in Morphine Equivalent Dose (mg).
|
Up to 24 hours post-extubation
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Mazzeffi M, Khelemsky Y. Poststernotomy pain: a clinical review. J Cardiothorac Vasc Anesth. 2011 Dec;25(6):1163-78. doi: 10.1053/j.jvca.2011.08.001. Epub 2011 Sep 29. No abstract available.
- Rothaug J, Zaslansky R, Schwenkglenks M, Komann M, Allvin R, Backstrom R, Brill S, Buchholz I, Engel C, Fletcher D, Fodor L, Funk P, Gerbershagen HJ, Gordon DB, Konrad C, Kopf A, Leykin Y, Pogatzki-Zahn E, Puig M, Rawal N, Taylor RS, Ullrich K, Volk T, Yahiaoui-Doktor M, Meissner W. Patients' perception of postoperative pain management: validation of the International Pain Outcomes (IPO) questionnaire. J Pain. 2013 Nov;14(11):1361-70. doi: 10.1016/j.jpain.2013.05.016. Epub 2013 Sep 7.
- Tulgar S, Ciftci B, Ahiskalioglu A, Bilal B, Sakul BU, Korkmaz AO, Bozkurt NN, De Cassai A, Torres AJ, Elsharkawy H, Alici HA. Serratus Posterior Superior Intercostal Plane Block: A Technical Report on the Description of a Novel Periparavertebral Block for Thoracic Pain. Cureus. 2023 Feb 3;15(2):e34582. doi: 10.7759/cureus.34582. eCollection 2023 Feb.
- Wang AH, Juan AH, Ko KD, Tsai PF, Zare H, Dell'Orso S, Sartorelli V. The Elongation Factor Spt6 Maintains ESC Pluripotency by Controlling Super-Enhancers and Counteracting Polycomb Proteins. Mol Cell. 2017 Oct 19;68(2):398-413.e6. doi: 10.1016/j.molcel.2017.09.016. Epub 2017 Oct 12.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 496
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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