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

NCT05764616 | Completed DMC

• 1 other identifier: PAR 06.23
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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)

Conditions

Cardiac Disease; Surgery; Analgesia; Acute Pain; Postoperative Pain

Outcome Measures

Primary Outcomes (2)

• 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

  24 hours

• 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

  24 hours

Secondary Outcomes (7)

• Intraoperative Fentanyl Consumption

  4 hours

• Morphine Consumption

  24 hours

• Time of Extubation

  48 hours

• Respiratory performance at incentive spirometry

  48 hours

• Intensive Care Unit (ICU) Discharge Time

  120 hours

Study Arms (2)

RECTUS group

EXPERIMENTAL

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

Procedure: PARASTERNAL BLOCK; Procedure: RECTUS SHEATH BLOCK

CONTROL group

ACTIVE COMPARATOR

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

Procedure: PARASTERNAL BLOCK; Procedure: LOCAL INFILTRATION OF DRAINAGE EXIT SITES

Interventions

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.

CONTROL group; RECTUS group

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

CONTROL group

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.

RECTUS group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Campus Bio-Medico University: lead

Study Sites (1)

Campus Bio-medico University Hospital Foundation

Rome, Italy

Location

Related Publications (6)

• 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.

  PMID: 33990437 RESULT

• 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.

  PMID: 17678782 RESULT

• 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.

  PMID: 27746544 RESULT

• 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.

  PMID: 31590939 RESULT

• 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.

  PMID: 35936156 RESULT

• 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.

  PMID: 38876800 DERIVED

MeSH Terms

Conditions

Heart Diseases; Agnosia; Acute Pain; Pain, Postoperative

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Postoperative Complications; Pathologic Processes

Study Officials

• Giuseppe Pascarella, MD

  University Hospital Campus Biomedico of Rome

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: March 10, 2023
• Study Start: March 21, 2023
• Primary Completion: October 10, 2023
• Study Completion: November 10, 2023
• Last Updated: November 27, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)