Opioid UseNCT05103787
Impact of Bilateral Deep Parasternal Intercostal Plane Block on Intraoperative Opioid Consumption in Open Heart Surgery
A study testing deep parasternal intercostal plane block in people with Opioid Use, run by Universitas Indonesia at 2 sites in Indonesia.
Trial summary
This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Opioid Use
- What is being tested?
- deep parasternal intercostal plane block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesIndonesia
- Study dates
- 4 Oct 2021to 4 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-70 years old
- Elective open-heart surgery with median sternotomy approach
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
A A G Putra Semara, doctor contact
Indonesia2 sites, 2 recruiting
- Recruiting
Universitas Indonesia
Central Jakarta, Indonesia, 10430
Aida Rosita R Tantri, 0213143336, aidatantri@gmail.com
- Recruiting
Cipto Mangunkusumo Cental National Hospital
Jakarta, DKI Jakarta, 10430
Aida R Tantri, Consultant, +628161832487, aidatantri@yahoo.com
About this study
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
This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery
Read the detailed 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.
- Conditions
- Opioid Use
- Being tested
- deep parasternal intercostal plane block, control
- Keywords
- regional anesthesia, intercostal plane block, opioid, open heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
deep parasternal intercostal plane blockProcedure or surgery
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.
controlProcedure or surgery
Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.
| Study group | Role | What they receive |
|---|---|---|
| deep parasternal plane block | Active comparator | Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia. Receives: Procedure: deep parasternal intercostal plane block; Procedure: 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, Receives: Procedure: deep parasternal intercostal plane block; Procedure: control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative fentanyl dose
Total intraoperative fentanyl dose will be calculated after surgery
Measured: intraoperatively
Secondary outcomes (4)
Time to first intraoperative fentanyl
Investigators will record time to first fentanyl dose after incision
Measured: intraoperatively
extubation time
Investigators will record time to extubation after surgery
Measured: Up to 72 hours after surgery
opioid side effects
Incidence of nausea and vomiting
Measured: within 24 hours after surgery
Intensive care unit length of stay
Investigators will record total time from intensive care unit admission until patient transferred to surgical wars
Measured: Up to 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2021
- Study start4 Oct 2021
- Primary completion4 Apr 2022 (estimated)
- Study completion4 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Opioid UseStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aida Rosita Tantri, Universitas Indonesia
- Investigators
- Aida Rosita R Tantri, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05103787
- Sponsor's protocol ID
- IndonesiaUAnes119
- Status last verified
- Oct 2021
- First submitted
- 27 Sep 2021
- Last updated
- 2 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 32665179Cardinale 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.
PubMed 32907499Chin 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.
PubMed 28419049Bloc 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.
PubMed 33990437Vilvanathan 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.
PubMed 33487833Probst 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.
PubMed 25123092Wong 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.
PubMed 27616189Chakravarthy 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.
PubMed 30052206
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05103787
- Acronym / sponsor ID
- IndonesiaUAnes119
- Conditions
- Opioid Use
- Keywords
- regional anesthesia, intercostal plane block, opioid, open heart surgery
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 4 Apr 2022 (estimated)
- Study completion
- 4 Jul 2022 (estimated)
- First posted
- 2 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to assess the impact of bilateral deep parasternal intercostal plane block on intraoperative opioid consumption in open heart surgery
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| deep parasternal plane block | Active comparator | Procedure: deep parasternal intercostal plane block, Procedure: controlSubjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia. |
| control | Placebo comparator | Procedure: deep parasternal intercostal plane block, Procedure: controlsubjects will receive skin puncture with needle on the same location as the treatment group without administration of local anesthetics after induction of anesthesia, |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-70 years old
- Elective open-heart surgery with median sternotomy approach
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| deep parasternal intercostal plane blockTwenty 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. | Procedure or surgery | control, deep parasternal plane block |
| controlSkin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics. | Procedure or surgery | control, deep parasternal plane block |
Primary outcome
Total intraoperative fentanyl dose
Time frame: intraoperatively
Total intraoperative fentanyl dose will be calculated after surgery
4 secondary outcomes
Time to first intraoperative fentanyl
Time frame: intraoperatively
extubation time
Time frame: Up to 72 hours after surgery
opioid side effects
Time frame: within 24 hours after surgery
Intensive care unit length of stay
Time frame: Up to 7 days after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2021.
- Results publication: PubMed 32665179Aydin 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.
- Results publication: PubMed 32907499Cardinale 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.
- Results publication: PubMed 28419049Chin 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.
- Results publication: PubMed 33990437Bloc 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.
- Results publication: PubMed 33487833Vilvanathan 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.
- Results publication: PubMed 25123092Probst 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.
- Results publication: PubMed 27616189Wong 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.
- Results publication: PubMed 30052206Chakravarthy 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
A A G Putra Semara, doctor contact
Aida Rosita R Tantri principal investigator
Universitas Indonesia
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing deep parasternal intercostal plane block in people with Opioid Use, run by Universitas Indonesia at 2 sites in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aida Rosita R Tantri, doctor (0213143336, aidatantri@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative fentanyl dose (time frame: intraoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05103787, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2021.