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

Official title

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.

Overview

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.

Interventions

• 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 intercosta
• 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 pro

Primary outcome measures

• Comparing the numerical rating scale scores [Time frame: Postoperative 24 hours]

Secondary outcome measures (1)

• Comparing total morphine consumption [Time frame: Postoperative 24 hours]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06553573 · PSB and RİFPB vs PSB and ESPB

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗