NCT05103787

Brief Summary

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2021

Completed
7 days until next milestone

Study Start

First participant enrolled

October 4, 2021

Completed
29 days until next milestone

First Posted

Study publicly available on registry

November 2, 2021

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 4, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 4, 2022

Completed
Last Updated

November 2, 2021

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

September 27, 2021

Last Update Submit

October 31, 2021

Conditions

Opioid Use

Keywords

regional anesthesiaintercostal plane blockopioidopen heart surgery

Outcome Measures

Primary Outcomes (1)

  • Total intraoperative fentanyl dose

    Total intraoperative fentanyl dose will be calculated after surgery

    intraoperatively

Secondary Outcomes (4)

  • Time to first intraoperative fentanyl

    intraoperatively

  • extubation time

    Up to 72 hours after surgery

  • opioid side effects

    within 24 hours after surgery

  • Intensive care unit length of stay

    Up to 7 days after surgery

Study Arms (2)

deep parasternal plane block

ACTIVE COMPARATOR

Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.

Procedure: deep parasternal intercostal plane blockProcedure: control

control

PLACEBO COMPARATOR

subjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia,

Procedure: deep parasternal intercostal plane blockProcedure: control

Interventions

deep parasternal intercostal plane blockPROCEDURE

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.

controldeep parasternal plane block
controlPROCEDURE

Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.

controldeep parasternal plane block

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18-70 years old
  • Elective open-heart surgery with median sternotomy approach

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

RECRUITING

Universitas Indonesia

Central Jakarta, Indonesia, 10430, Indonesia

RECRUITING

Related 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 Study. J Cardiothorac Vasc Anesth. 2020 Nov;34(11):2996-3003. doi: 10.1053/j.jvca.2020.06.044. Epub 2020 Jun 18.

    PMID: 32665179RESULT

  • 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.

    PMID: 32907499RESULT

  • 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.

    PMID: 28419049RESULT

  • 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: 33990437RESULT

  • 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.

    PMID: 33487833RESULT

  • 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.

    PMID: 25123092RESULT

  • 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.

    PMID: 27616189RESULT

  • 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.

    PMID: 30052206RESULT

Study Officials

  • Aida Rosita R Tantri

    Indonesia University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aida Rosita R Tantri, doctor

CONTACT

0213143336aidatantri@gmail.com

A A G Putra Semara, doctor

CONTACT

0213143336

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

September 27, 2021

First Posted

November 2, 2021

Study Start

October 4, 2021

Primary Completion

April 4, 2022

Study Completion

July 4, 2022

Last Updated

November 2, 2021

Record last verified: 2021-10

Locations

ID(2)