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

Sponsor

Indonesia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05103787

Collaborator

(none)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Opioid Use	Procedure: deep parasternal intercostal plane block Procedure: control	N/A

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

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Oct 4, 2021

Anticipated Primary Completion Date :

Apr 4, 2022

Anticipated Study Completion Date :

Jul 4, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: deep parasternal plane block Subjects will receive bilateral deep parasternal intercostal plane block after induction of anesthesia.	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. Procedure: control Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.
Placebo Comparator: 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,	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. Procedure: control Skin puncture with needle will be performed on the same location as the treatment group without administration of local anesthetics.

Arm

Intervention/Treatment

Active Comparator: deep parasternal plane block

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

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.

Procedure: control

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

Placebo Comparator: 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,

Procedure: deep parasternal intercostal plane block

Procedure: control

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

Outcome Measures

Primary Outcome Measures

Total intraoperative fentanyl dose [intraoperatively]
Total intraoperative fentanyl dose will be calculated after surgery

Secondary Outcome Measures

Time to first intraoperative fentanyl [intraoperatively]
Investigators will record time to first fentanyl dose after incision
extubation time [Up to 72 hours after surgery]
Investigators will record time to extubation after surgery
opioid side effects [within 24 hours after surgery]
Incidence of nausea and vomiting
Intensive care unit length of stay [Up to 7 days after surgery]
Investigators will record total time from intensive care unit admission until patient transferred to surgical wars

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta	Indonesia	10430
2	Universitas Indonesia	Central Jakarta		Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

Principal Investigator: Aida Rosita R Tantri, Indonesia University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aida Rosita Tantri, Doctor, Indonesia University

ClinicalTrials.gov Identifier:

NCT05103787

Other Study ID Numbers:

IndonesiaUAnes119

First Posted:

Nov 2, 2021

Last Update Posted:

Nov 2, 2021

Last Verified:

Oct 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Aida Rosita Tantri, Doctor, Indonesia University

regional anesthesia

intercostal plane block

opioid

open heart surgery

Study Results

No Results Posted as of Nov 2, 2021