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

C

Cumhuriyet University

Status

Not yet enrolling

Conditions

Post Operative Pain

Treatments

Other: Parasternal Block and Recto-İntercostal Fascial Plane Block
Other: Parasternal Block and Erector Spinae Plane Block

Study type

Interventional

Funder types

Other

Identifiers

NCT06553573
PSB and RİFPB vs PSB and ESPB

Details and patient eligibility

About

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.

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 85 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

24 participants in 2 patient groups

Parasternal Block and Recto-İntercostal Fascial Plane Block
Active Comparator group
Description:
Before surgery, patients will receive a combination of bilateral PSB and RIFPB with 0.25% bupivacaine (total volume 60 ml) for postoperative pain control.
Treatment:
Other: Parasternal Block and Recto-İntercostal Fascial Plane Block
Parasternal Block and Erector Spinae Plane Block
Active Comparator group
Description:
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.
Treatment:
Other: Parasternal Block and Erector Spinae Plane Block

Trial contacts and locations

0

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Central trial contact

Oğuz Gündoğdu; Onur Avcı

Data sourced from clinicaltrials.gov

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