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Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy (PARARECTUS)

C

Campus Bio-Medico University of Rome

Status

Completed

Conditions

Postoperative Pain
Cardiac Disease
Surgery
Analgesia
Acute Pain

Treatments

Procedure: PARASTERNAL BLOCK
Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES
Procedure: RECTUS SHEATH BLOCK

Study type

Interventional

Funder types

Other

Identifiers

NCT05764616
PAR 06.23

Details and patient eligibility

About

The aim of this randomized controlled trial is to examine the effect of ultrasound guided bilateral Parasternal Nerve Block combined with rectus sheath block on preoperative analgesia, opioid consumption and respiratory function in patients undergoing cardiac surgery via sternotomy. Half of participants will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block while the other half receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic (without performing rectus sheath block)

Enrollment

58 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients undergoing elective cardiac surgery under median sternotomy
  • Age >= 18 years
  • American Society of Anesthesiologists (ASA) Status I-IV
  • Approval and sign of the informed consent

Exclusion criteria

  • Allergy to local anesthetics
  • Puncture site infection
  • Lack of signing of informed consent
  • Age <18 years
  • Emergency surgery
  • ASA > IV
  • preoperative acute respiratory failure

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

58 participants in 2 patient groups

RECTUS group
Experimental group
Description:
Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block
Treatment:
Procedure: RECTUS SHEATH BLOCK
Procedure: PARASTERNAL BLOCK
CONTROL group
Active Comparator group
Description:
Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic
Treatment:
Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES
Procedure: PARASTERNAL BLOCK

Trial contacts and locations

1

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Central trial contact

Giuseppe Pascarella, MD

Data sourced from clinicaltrials.gov

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