Clinical trial NCT06553573: 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.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Post Operative Pain
Keywords: sternotomy
cardiac surgery
parasternal block
recto-intercostal fascial plane block
erector spinae plane block
regional anesthesia
postoperative pain
Lead sponsor: Cumhuriyet University
Sponsor class: OTHER
First posted: 2024-08-14
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Comparing the numerical rating scale scores
timeFrame: Postoperative 24 hours
Secondary outcomes:
measure: Comparing total morphine consumption
timeFrame: Postoperative 24 hours
Other outcomes:
Locations:
Study officials:
affiliation: Sivas Cumhuriyet University School of Medicine, Anesthesiology and Reanimation
name: Oğuz Gündoğdu
role: PRINCIPAL_INVESTIGATOR
References: