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Cardiac DiseasePARARECTUSNCT05764616

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

A study testing PARASTERNAL BLOCK, LOCAL INFILTRATION OF DRAINAGE EXIT SITES and RECTUS SHEATH BLOCK in people with Cardiac Disease and Surgery, run by Campus Bio-Medico University at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cardiac Disease, Surgery, Analgesia
What is being tested?
PARASTERNAL BLOCK, LOCAL INFILTRATION OF DRAINAGE EXIT SITES and RECTUS SHEATH BLOCK
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
58 participants
Where
1 siteItaly
Study dates
21 Mar 2023to 10 Nov 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Italy1 site

  • Campus Bio-medico University Hospital Foundation

    Rome

Other trials in Italy

About this study

Official title: 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)

Being tested
PARASTERNAL BLOCK, LOCAL INFILTRATION OF DRAINAGE EXIT SITES, RECTUS SHEATH BLOCK
Medical subject headings
Heart Diseases, Agnosia, Acute Pain, Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PARASTERNAL BLOCKProcedure or surgery

    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 SITESProcedure or surgery

    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 BLOCKProcedure or surgery

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

Study groups in NCT05764616
Study groupRoleWhat they receive
RECTUS groupExperimentalPatients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block
Receives: Procedure: PARASTERNAL BLOCK; Procedure: RECTUS SHEATH BLOCK
CONTROL groupActive comparatorPatients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic
Receives: Procedure: PARASTERNAL BLOCK; Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Static Pain Score

    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

    Measured: 24 hours

  2. Dynamic Pain Score

    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

    Measured: 24 hours

Secondary outcomes (7)

  1. Intraoperative Fentanyl Consumption

    Total intravenous fentanyl administration (expressed in milligrams) during surgery

    Measured: 4 hours

  2. Morphine Consumption

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

    Measured: 24 hours

  3. Time of Extubation

    Interval between the end of surgery and patient's extubation

    Measured: 48 hours

  4. Respiratory performance at incentive spirometry

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

    Measured: 48 hours

  5. Intensive Care Unit (ICU) Discharge Time

    Interval between patient arrival in ICU and discharge from ICU

    Measured: 120 hours

  6. Hospitalization Length of Stay

    Total Hospital length of Stay (expressed in days)

    Measured: 30 days

  7. Incidence of adverse events

    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.

    Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2023
  2. Study start21 Mar 2023
  3. Primary completion10 Oct 2023
  4. Study completion10 Nov 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05764616
Sponsor's protocol ID
PAR 06.23
Acronym
PARARECTUS
Status last verified
Nov 2023
First submitted
27 Feb 2023
Last updated
27 Nov 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquiere C, Luka M, Waldmann T, Vistarini N, Aubert S, Menager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in coronary artery bypass surgery via sternotomy: a randomized controlled trial. Reg Anesth Pain Med. 2021 Aug;46(8):671-678. doi: 10.1136/rapm-2020-102207. Epub 2021 May 14.

    PubMed 33990437

  • Barr AM, Tutungi E, Almeida AA. Parasternal intercostal block with ropivacaine for pain management after cardiac surgery: a double-blind, randomized, controlled trial. J Cardiothorac Vasc Anesth. 2007 Aug;21(4):547-53. doi: 10.1053/j.jvca.2006.09.003. Epub 2006 Dec 22.

    PubMed 17678782

  • Elbahrawy K, El-Deeb A. Rectus sheath block for postoperative analgesia in patients with mesenteric vascular occlusion undergoing laparotomy: A randomized single-blinded study. Anesth Essays Res. 2016 Sep-Dec;10(3):516-520. doi: 10.4103/0259-1162.179315.

    PubMed 27746544

  • Cibelli M, Brodier EA, Smith FG. Pectoralis-Intercostal-Rectus Sheath (PIRS) Plane Block With Catheters. A New Technique to Provide Analgesia in Cardiac Surgery. J Cardiothorac Vasc Anesth. 2020 Mar;34(3):846-847. doi: 10.1053/j.jvca.2019.09.014. Epub 2019 Sep 18. No abstract available.

    PubMed 31590939

  • Everett L, Davis TA, Deshpande SP, Mondal S. Implementation of Bilateral Rectus Sheath Blocks in Conjunction With Transversus Thoracis Plane and Pectointercostal Fascial Blocks for Immediate Postoperative Analgesia After Cardiac Surgery. Cureus. 2022 Jul 5;14(7):e26592. doi: 10.7759/cureus.26592. eCollection 2022 Jul.

    PubMed 35936156

  • Strumia A, Pascarella G, Sarubbi D, Di Pumpo A, Costa F, Conti MC, Rizzo S, Stifano M, Mortini L, Cassibba A, Schiavoni L, Mattei A, Ruggiero A, Agro FE, Carassiti M, Cataldo R. Rectus sheath block added to parasternal block may improve postoperative pain control and respiratory performance after cardiac surgery: a superiority single-blinded randomized controlled clinical trial. Reg Anesth Pain Med. 2025 Sep 4;50(9):712-718. doi: 10.1136/rapm-2024-105430.

    PubMed 38876800

Questions about this trial

What is this clinical trial studying?

A study testing PARASTERNAL BLOCK, LOCAL INFILTRATION OF DRAINAGE EXIT SITES and RECTUS SHEATH BLOCK in people with Cardiac Disease and Surgery, run by Campus Bio-Medico University at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Static Pain Score (time frame: 24 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05764616, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Nov 2023.

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