Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery

Opioid Use Clinical Trial

Official title:

Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery: a Prospective, Double-blind Randomized Controlled Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05103787
• Other study ID #: IndonesiaUAnes119
• Status: Recruiting
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: July 4, 2022

Study information

• Verified date: October 2021
• Source: Indonesia University
• Contact: Aida Rosita R Tantri, doctor
• Phone: 0213143336
• Email: aidatantri[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery

Description:

High-dose opioid is associated with various side effects such as nausea, vomiting, urinary retention, and respiratory depression. The neuraxial block (intrathecal, epidural) and peripheral nerve block are regional anesthesia techniques which have the potential to reduce intraoperative opioid consumption. The deep parasternal intercostal plane block is fascial plane block which intended to block anterior cutaneous branch of intercostal nerves.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 4, 2022
• Est. primary completion date: April 4, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 18-70 years old

• Elective open-heart surgery with median sternotomy approach

Exclusion Criteria:

• Patient who refuses to participate

• 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

Related Conditions & MeSH terms

• Opioid Use

Intervention

Procedure:
• 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.

Locations

Country	Name	City	State
Indonesia	Universitas Indonesia	Central Jakarta
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

References & Publications (8)

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 Stud — View Citation

Bloc S, Perot BP, Gibert H, Law Koune JD, Burg Y, Leclerc D, Vuitton AS, De La Jonquière C, Luka M, Waldmann T, Vistarini N, Aubert S, Ménager MM, Merzoug M, Naudin C, Squara P. Efficacy of parasternal block to decrease intraoperative opioid use in corona — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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 — View Citation

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:CD003587. doi: 10.1002/14651858.CD003587.pub3. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total intraoperative fentanyl dose	Total intraoperative fentanyl dose will be calculated after surgery	intraoperatively
Secondary	Time to first intraoperative fentanyl	Investigators will record time to first fentanyl dose after incision	intraoperatively
Secondary	extubation time	Investigators will record time to extubation after surgery	Up to 72 hours after surgery
Secondary	opioid side effects	Incidence of nausea and vomiting	within 24 hours after surgery
Secondary	Intensive care unit length of stay	Investigators will record total time from intensive care unit admission until patient transferred to surgical wars	Up to 7 days after surgery