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

Primary Purpose

Cardiac Disease, Surgery, Analgesia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
PARASTERNAL BLOCK
LOCAL INFILTRATION OF DRAINAGE EXIT SITES
RECTUS SHEATH BLOCK
Sponsored by
Campus Bio-Medico University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cardiac Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Campus Bio-medico University Hospital Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

RECTUS group

CONTROL group

Arm Description

Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block

Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
February 27, 2023
Last Updated
March 9, 2023
Sponsor
Campus Bio-Medico University
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1. Study Identification

Unique Protocol Identification Number
NCT05764616
Brief Title
Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy
Acronym
PARARECTUS
Official Title
Ultrasound Guided Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
March 2023 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Campus Bio-Medico University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiac Disease, Surgery, Analgesia, Acute Pain, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
RECTUS group
Arm Type
Experimental
Arm Description
Patients will receive General Anesthesia combined with bilateral parasternal block and rectus sheath block
Arm Title
CONTROL group
Arm Type
Active Comparator
Arm Description
Patients will receive General Anesthesia combined with bilateral parasternal block and infiltration of drainage exits sites with local anesthetic
Intervention Type
Procedure
Intervention Name(s)
PARASTERNAL BLOCK
Intervention Description
After induction of general anesthesia, an ultrasound-guided Parasternal Block will be performed with 20 mL of ropivacaine 0.5 % per side.
Intervention Type
Procedure
Intervention Name(s)
LOCAL INFILTRATION OF DRAINAGE EXIT SITES
Intervention Description
At the end of surgery, a local infiltration of drainage exit sites will be performed with 10 mL of ropivacaine 0.25% per side
Intervention Type
Procedure
Intervention Name(s)
RECTUS SHEATH BLOCK
Intervention Description
At the end of surgery, a rectus sheath block will be performed with 10 mL of ropivacaine 0.25% per side.
Primary Outcome Measure Information:
Title
Static Pain Score
Description
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
Time Frame
24 hours
Title
Dynamic Pain Score
Description
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
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Intraoperative Fentanyl Consumption
Description
Total intravenous fentanyl administration (expressed in milligrams) during surgery
Time Frame
4 hours
Title
Morphine Consumption
Description
Total of intravenous morphine (expressed in milligrams) administered during the first 24 hours after surgery
Time Frame
24 hours
Title
Time of Extubation
Description
Interval between the end of surgery and patient's extubation
Time Frame
48 hours
Title
Respiratory performance at incentive spirometry
Description
Respiratory performance is assessed preoperatively and postoperatively (at extubation) by the number of balls raised during inspiration with the TRI-FLOW spirometer
Time Frame
48 hours
Title
Intensive Care Unit (ICU) Discharge Time
Description
Interval between patient arrival in ICU and discharge from ICU
Time Frame
120 hours
Title
Hospitalization Length of Stay
Description
Total Hospital length of Stay (expressed in days)
Time Frame
30 days
Title
Incidence of adverse events
Description
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.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Giuseppe Pascarella, MD
Phone
00393204022283
Email
g.pascarella@policlinicocampus.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Giuseppe Pascarella, MD
Organizational Affiliation
University Hospital Campus Biomedico of Rome
Official's Role
Principal Investigator
Facility Information:
Facility Name
Campus Bio-medico University Hospital Foundation
City
Rome
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33990437
Citation
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.
Results Reference
result
PubMed Identifier
17678782
Citation
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.
Results Reference
result
PubMed Identifier
27746544
Citation
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.
Results Reference
result
PubMed Identifier
31590939
Citation
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.
Results Reference
result
PubMed Identifier
35936156
Citation
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.
Results Reference
result

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

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