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

Not Applicable

Not yet recruiting

• Conditions: Post Operative Pain
• Interventions: Other: Parasternal Block and Recto-İntercostal Fascial Plane Block; Other: Parasternal Block and Erector Spinae Plane Block

• Registration Number: NCT06553573
• Lead Sponsor: Cumhuriyet University

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.

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-12
• Study First Submitted QC: 2024-08-12
• Last Update Submitted: 2024-08-12
• Study First Posted: 2024-08-14
• Last Update Posted: 2024-08-14
• Study Start: 2024-08-15
• Primary Completion: 2024-09-15
• Study Completion: 2024-09-20

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 24

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Parasternal Block and Recto-İntercostal Fascial Plane Block	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.
Parasternal Block and Erector Spinae Plane Block	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.

Primary Outcome Measures

Name	Time	Method
Comparing the numerical rating scale scores	Postoperative 24 hours	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.

Secondary Outcome Measures

Name	Time	Method
Comparing total morphine consumption	Postoperative 24 hours	Postoperative analgesic need