Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery
NCT ID: NCT05103787
Last Updated: 2021-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-10-04
2022-07-04
Brief Summary
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Detailed Description
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This study is a double-blind randomized controlled trial. Thirty subjects will be recruited with consecutive sampling method. Eligible subjects with signed informed consent will be randomized into two groups. The first group is the treatment group who will receive bilateral deep parasternal intercostal plane block after induction of anesthesia and the second group will be the control group who will not receive any regional anesthesia. After surgery, extubation time, adverse event (nausea, vomiting), and intensive care unit length of stay will be recorded for both groups.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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deep parasternal plane block
Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.
deep parasternal intercostal plane block
Twenty milliliters of 0.25% bupivacaine will be placed bilaterally in the fascial plane between internal intercostal muscle and transversus thoracis muscle at intercostal space 4 or 5, lateral from sternum, with ultrasound guidance using high-frequency linear transducer.
control
Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.
control
subjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia,
deep parasternal intercostal plane block
Twenty milliliters of 0.25% bupivacaine will be placed bilaterally in the fascial plane between internal intercostal muscle and transversus thoracis muscle at intercostal space 4 or 5, lateral from sternum, with ultrasound guidance using high-frequency linear transducer.
control
Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.
Interventions
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deep parasternal intercostal plane block
Twenty milliliters of 0.25% bupivacaine will be placed bilaterally in the fascial plane between internal intercostal muscle and transversus thoracis muscle at intercostal space 4 or 5, lateral from sternum, with ultrasound guidance using high-frequency linear transducer.
control
Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.
Eligibility Criteria
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Inclusion Criteria
* Elective open-heart surgery with median sternotomy approach
Exclusion Criteria
* Patient with local infection in the block area
* Patient with chronic pain
* Patient with history of chronic analgesics use
* Patient who is contraindicated for local anesthetics
* Patient with cognitive disorder
* Patient with severe psychiatric disorders
18 Years
70 Years
ALL
Yes
Sponsors
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Indonesia University
OTHER
Responsible Party
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Aida Rosita Tantri
Doctor
Principal Investigators
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Aida Rosita R Tantri
Role: PRINCIPAL_INVESTIGATOR
Indonesia University
Locations
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Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, Indonesia
Universitas Indonesia
Central Jakarta, Indonesia, Indonesia
Countries
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Central Contacts
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A A G Putra Semara, doctor
Role: CONTACT
Phone: 0213143336
Facility Contacts
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Aida R Tantri, Consultant
Role: primary
Aida Rosita R Tantri
Role: primary
References
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Aydin ME, Ahiskalioglu A, Ates I, Tor IH, Borulu F, Erguney OD, Celik M, Dogan N. Efficacy of Ultrasound-Guided Transversus Thoracic Muscle Plane Block on Postoperative Opioid Consumption After Cardiac Surgery: A Prospective, Randomized, Double-Blind Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.
Cardinale JP, Latimer R, Curtis C, Bukovskaya Y, Kosarek L, Falterman J, Tatum DM, Trusheim J. Incorporation of the Transverse Thoracic Plane Block Into a Multimodal Early Extubation Protocol for Cardiac Surgical Patients. Semin Cardiothorac Vasc Anesth. 2021 Dec;25(4):301-309. doi: 10.1177/1089253220957484. Epub 2020 Sep 9.
Chin KJ. An Anatomical Basis for Naming Plane Blocks of the Anteromedial Chest Wall. Reg Anesth Pain Med. 2017 May/Jun;42(3):414-415. doi: 10.1097/AAP.0000000000000575. No abstract available.
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.
Vilvanathan S, Saravanababu MS, Sreedhar R, Gadhinglajkar SV, Dash PK, Sukesan S. Ultrasound-guided Modified Parasternal Intercostal Nerve Block: Role of Preemptive Analgesic Adjunct for Mitigating Poststernotomy Pain. Anesth Essays Res. 2020 Apr-Jun;14(2):300-304. doi: 10.4103/aer.AER_32_20. Epub 2020 Oct 12.
Probst S, Cech C, Haentschel D, Scholz M, Ender J. A specialized post anaesthetic care unit improves fast-track management in cardiac surgery: a prospective randomized trial. Crit Care. 2014 Aug 15;18(4):468. doi: 10.1186/s13054-014-0468-2.
Wong WT, Lai VK, Chee YE, Lee A. Fast-track cardiac care for adult cardiac surgical patients. Cochrane Database Syst Rev. 2016 Sep 12;9(9):CD003587. doi: 10.1002/14651858.CD003587.pub3.
Chakravarthy M. Regional analgesia in cardiothoracic surgery: A changing paradigm toward opioid-free anesthesia? Ann Card Anaesth. 2018 Jul-Sep;21(3):225-227. doi: 10.4103/aca.ACA_56_18. No abstract available.
Other Identifiers
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IndonesiaUAnes119
Identifier Type: -
Identifier Source: org_study_id