Comparison of PSB and RIFPB Combination With PSB and ESPB Combination in Cardiac Surgery With Sternotomy

Postoperative Analgesic Efficacy Comparison of a Combination of Superficial Parasternal Block (PSB) and Recto-intercostal Fascial Plane Block (RİFPB) Versus a Combination of Erector Spinae Plane Block (ESPB) and Superficial Parasternal Block (PSB) in Patients Undergoing Cardiac Surgery With Sternotomy.

The goal of this study is to compare the analgesic efficacy of the combination of PSB and RIFPB and the combination of PSB and ESPB in patients undergoing cardiac surgery with sternotomy.

Study Overview

• Status: Not yet recruiting
• Conditions: Post Operative Pain
• Intervention / Treatment: Other: Parasternal Block and Recto-İntercostal Fascial Plane Block; Other: Parasternal Block and Erector Spinae Plane Block

Detailed Description

This study will consist of two randomized groups: Group RIFPB (n=12), Group ESP (n=12). All patients will receive standard general anesthesia. Group RIFPB patients will receive PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. Group ESPB patients will receive PSB and ESPB with 0.25% bupivacaine (total volume 60 ml) bilaterally. All blocks will be performed after induction of general anesthesia and before surgical incision. All patients in the study will be given 50 mg dexketoprofen and 1 g paracetamol intravenously (i.v.) 10 minutes before skin closure. Within the first 24 hours after surgery, all patients will be given 3x1 g iv paracetamol and 2x50 mg dexketoprofen. Numerical Rating Scale (NRS) will be used to assess postoperative pain at 1, 6, 12, 18 and 24 hours. All patients will receive morphine via a patient-controlled analgesia (PCA) device within 24 hours of surgery. If pain score is ≥ 4 despite this protocol, 50 mg tramadol iv (maximum dose 300 mg/day) will be administered as rescue analgesia.

• Study Type: Interventional
• Enrollment (Estimated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: OĞUZ GÜNDOĞDU; Phone Number: +905545945469; Email: droguzgundogdu@gmail.com
• Study Contact Backup: Name: Onur Avcı; Phone Number: +905301126408; Email: dronuravci@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adult patients over 18 years of age who will undergo cardiac surgery with sternotomy under general anesthesia and who are in classes I-IIIII according to the American Society of Anesthesiologists (ASA) risk classification.

Exclusion Criteria:

• Patients who did not give consent,
• patients with coagulopathy,
• patients with signs of infection at the block application site,
• patients using anticoagulants,
• patients with local anesthetic drug allergies,
• patients with unstable hemodynamics,
• patients who could not cooperate during postoperative pain assessment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Parasternal Block and Recto-İntercostal Fascial Plane Block; Before surgery, patients will receive a combination of bilateral PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) for postoperative pain control.	Other: Parasternal Block and Recto-İntercostal Fascial Plane Block; Parasternal Block and Recto-Intercostal Fascial Plane Block:Superficial PSB is performed bilaterally with the patient in the supine position using a high-frequency linear USG probe. The probe is inserted longitudinally 2cm lateral to the sternal border to visualize the T2T4 intercostal space and identify the pectoralis major muscle, intercostal muscle, and pleura. Using an in-plane approach with a 100mm needle, 10ml of 0.25% bupivacaine is administered between the pectoralis major and intercostal muscle. Additionally, a Recto-Intercostal Fascial Plane Block is performed bilaterally with a high-frequency linear USG probe. The probe is inserted 2-3cm lateral to the xiphoid to visualize the rectus abdominis muscle and the 6th-7th cartilages. The needle is advanced to the plane between the costal cartilage and the rectus abdominis muscle using the in-plane technique, and 1-2ml of saline is injected. After spreading to the target plane is observed, 20ml of 0.25% bupivacaine is administered.
Active Comparator: Parasternal Block and Erector Spinae Plane Block; Before surgery, patients will be given 0.25% bupivacaine (total volume 60 ml) with a combination of bilateral PSB and ESPB for postoperative pain control.	Other: Parasternal Block and Erector Spinae Plane Block; Superficial PSB is performed with the patient in the supine position using a high-frequency linear USG probe. The probe is placed longitudinally 2cm lateral to the sternal border to identify the T2T4 intercostal space, pectoralis major muscle, intercostal muscle, and pleura. Using an in-plane approach with a 100mm needle, 10ml of 0.25% bupivacaine is applied between the pectoralis major and intercostal muscle. Additionally, an erector spinae plane block is performed with a high-frequency USG probe. Erector spinae plane block is performed under general anesthesia, in the lateral position, under USG guidance, after sterilization, by inserting a needle between the deep surface of the erector spinae muscle and the transverse process with an in-plane approach in the craniocaudal direction. If no air or blood is seen in the aspiration, a 2mL serum test dose is applied to this area and a total of 20mL of 0.25% bupivacaine is injected bilaterally to perform an erector spinae plane block.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing the numerical rating scale scores	Numerical rating scale will be used for pain assessment. The scores of the numerical rating scale changes between 0 to 10 points. 10 points mean "the most severe pain that the patient ever had". 0 point means "there is no pain." Higher scores mean worse outcome.	Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparing total morphine consumption	Postoperative analgesic need	Postoperative 24 hours

Collaborators and Investigators

• Sponsor: Cumhuriyet University
• Investigators: Principal Investigator: OĞUZ GÜNDOĞDU, Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2024
• Primary Completion (Estimated): September 15, 2024
• Study Completion (Estimated): September 20, 2024

Study Registration Dates

• First Submitted: August 12, 2024
• First Submitted That Met QC Criteria: August 12, 2024
• First Posted (Actual): August 14, 2024

Study Record Updates

• Last Update Posted (Actual): August 14, 2024
• Last Update Submitted That Met QC Criteria: August 12, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: cardiac surgery; postoperative pain; regional anesthesia; erector spinae plane block; sternotomy; parasternal block; recto-intercostal fascial plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: PSB and RİFPB vs PSB and ESPB

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No