Clinical trial NCT05764616: Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy
Official title: Ultrasound Guided Parasternal Block Combined With Rectus Sheath Block for Cardiac Surgery Under Sternotomy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Disease
Surgery
Analgesia
Acute Pain
Postoperative Pain
Lead sponsor: Campus Bio-Medico University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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

Primary outcomes:
measure: Static Pain Score
timeFrame: 24 hours
measure: Dynamic Pain Score
timeFrame: 24 hours
Secondary outcomes:
measure: Intraoperative Fentanyl Consumption
timeFrame: 4 hours
measure: Morphine Consumption
timeFrame: 24 hours
measure: Time of Extubation
timeFrame: 48 hours
measure: Respiratory performance at incentive spirometry
timeFrame: 48 hours
measure: Intensive Care Unit (ICU) Discharge Time
timeFrame: 120 hours
measure: Hospitalization Length of Stay
timeFrame: 30 days
measure: Incidence of adverse events
timeFrame: 24 hours
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Campus Bio-medico University Hospital Foundation
Study officials:
affiliation: University Hospital Campus Biomedico of Rome
name: Giuseppe Pascarella, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.