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

November 24, 2023 updated by: Giuseppe Pascarella, Campus Bio-Medico University

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • Campus Bio-medico University Hospital Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: RECTUS group
Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block
Procedure: PARASTERNAL BLOCK
After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.
Procedure: RECTUS SHEATH BLOCK
At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side.
Active Comparator: CONTROL group
Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic
Procedure: PARASTERNAL BLOCK
After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.
Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES
At the end of surgery, a local infiltration of drainage exit sites will be performed with 10 mL of ropivacaine 0.25% per side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
24 hours
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
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative Fentanyl Consumption
Time Frame: 4 hours
Total intravenous fentanyl administration (expressed in milligrams) during surgery
4 hours
Morphine Consumption
Time Frame: 24 hours
Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery
24 hours
Time of Extubation
Time Frame: 48 hours
Interval between the end of surgery and patient's extubation
48 hours
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
48 hours
Intensive Care Unit (ICU) Discharge Time
Time Frame: 120 hours
Interval between patient arrival in ICU and discharge from ICU
120 hours
Hospitalization Length of Stay
Time Frame: 30 days
Total Hospital length of Stay (expressed in days)
30 days
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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Campus Bio-Medico University

Investigators

  • Principal Investigator: Giuseppe Pascarella, MD, University Hospital Campus Biomedico of Rome

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 21, 2023

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

November 10, 2023

Study Registration Dates

First Submitted

February 27, 2023

First Submitted That Met QC Criteria

March 9, 2023

First Posted (Actual)

March 10, 2023

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PAR 06.23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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