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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05103787
Enrollment
30
Registered
2021-11-02
Start date
2021-10-04
Completion date
2022-07-04
Last updated
2021-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use

Keywords

regional anesthesia, intercostal plane block, opioid, open heart surgery

Brief summary

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.

Interventions

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.

PROCEDUREcontrol

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

Sponsors

Indonesia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Total intraoperative fentanyl doseintraoperativelyTotal intraoperative fentanyl dose will be calculated after surgery

Secondary

MeasureTime frameDescription
opioid side effectswithin 24 hours after surgeryIncidence of nausea and vomiting
extubation timeUp to 72 hours after surgeryInvestigators will record time to extubation after surgery
Time to first intraoperative fentanylintraoperativelyInvestigators will record time to first fentanyl dose after incision
Intensive care unit length of stayUp to 7 days after surgeryInvestigators will record total time from intensive care unit admission until patient transferred to surgical wars

Countries

Indonesia

Contacts

Primary ContactAida Rosita R Tantri, doctor
aidatantri@gmail.com0213143336
Backup ContactA A G Putra Semara, doctor
0213143336

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026