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Completed

NCT Number: NCT05764616

Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy

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)

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Key information

Conditions

Cardiac Disease Acute Pain Agnosia Analgesia Cardiovascular Diseases Heart Diseases Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Postoperative Pain Signs and Symptoms Surgery

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Campus Bio-medico University Hospital Foundation

Rome, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

parasternal block

Procedure

After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.

LOCAL INFILTRATION OF DRAINAGE EXIT SITES

Procedure

At the end of surgery, a local infiltration of drainage exit sites will be performed with 10 mL of ropivacaine 0.25% per side

Rectus sheath block

Procedure

At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side.

Primary outcomes

  1. Static Pain Score

    Time frame: 24 hours

    A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) will be used to evaluate pain at rest during 24 hours after surgery

  2. Dynamic Pain Score

    Time frame: 24 hours

    A numerical rating scale (NRS) from 0 (no pain) to 10 (worst imaginable pain) during movement will be used to evaluate pain at rest during 24 hours after surgery

Secondary outcomes

  1. Intraoperative Fentanyl Consumption

    Time frame: 4 hours

    Total intravenous fentanyl administration (expressed in milligrams) during surgery

  2. Morphine Consumption

    Time frame: 24 hours

    Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery

  3. Time of Extubation

    Time frame: 48 hours

    Interval between the end of surgery and patient's extubation

  4. Respiratory performance at incentive spirometry

    Time frame: 48 hours

    Respiratory performance is assessed preoperatively and postoperatively (at extubation) by the number of balls raised during inspiration with the TRI-FLOW spirometer

  5. Intensive Care Unit (ICU) Discharge Time

    Time frame: 120 hours

    Interval between patient arrival in ICU and discharge from ICU

  6. Hospitalization Length of Stay

    Time frame: 30 days

    Total Hospital length of Stay (expressed in days)

  7. Incidence of adverse events

    Time frame: 24 hours

    Any complications or side effects of the blocks, such as local infection, intravascular injection of local anesthetics and immediate systemic toxicity.

    Moreover, incidence of nausea, vomiting and postoperative respiratory complications will be recorded.

Sponsors and collaborators

Lead sponsor

Campus Bio-Medico University

Other

Registry information

Official study title

Ultrasound Guided Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy: A Randomized Controlled Trial

Acronym: PARARECTUS

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 10, 2023
Registry last updated
Nov 27, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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