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

NCT ID: NCT06553573

Last Updated: 2024-08-14

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-15
• Study Completion Date: 2024-09-20

Brief Summary

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.

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.

Conditions

Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Parasternal Block and Recto-İntercostal Fascial Plane Block

Intervention Type: OTHER

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.

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.

Group Type: ACTIVE_COMPARATOR

Parasternal Block and Erector Spinae Plane Block

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Cumhuriyet University

OTHER

Sponsor Role: lead

Responsible Party

Oguz Gundogdu

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Oğuz Gündoğdu

Role: PRINCIPAL_INVESTIGATOR

Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation

Central Contacts

Oğuz Gündoğdu

Role: CONTACT

droguzgundogdu@gmail.com

+905545945469

Onur Avcı

Role: CONTACT

dronuravci@gmail.com

+905301126408

Other Identifiers

PSB and RİFPB vs PSB and ESPB

Identifier Type: -

Identifier Source: org_study_id