UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061158 |
|---|---|
| Receipt number | R000069987 |
| Scientific Title | Optimizing Initial Bolus Volume During Serratus Anterior Plane Block Catheter Placement for Programmed Intermittent Bolus Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/04/05 |
| Last modified on | 2026/04/04 14:17:25 |
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Basic information
Public title
Optimizing Initial Bolus Volume During Serratus Anterior Plane Block Catheter Placement for Programmed Intermittent Bolus Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial
Acronym
Initial Bolus Optimization Study for Serratus Block with Programmed Intermittent Bolus in MICS
Scientific Title
Optimizing Initial Bolus Volume During Serratus Anterior Plane Block Catheter Placement for Programmed Intermittent Bolus Analgesia in Minimally Invasive Cardiac Surgery: A Randomized Controlled Trial
Scientific Title:Acronym
Initial Bolus Optimization Study for Serratus Block with Programmed Intermittent Bolus in MICS
Region
| Japan |
Condition
Condition
Postoperative pain in minimally invasive cardiac surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the effect of the initial injection volume prior to catheter placement on catheter tip position in serratus anterior plane block, by comparing a low-volume group (3 mL) and a high-volume group (40 mL).
Basic objectives2
Others
Basic objectives -Others
technical optimization
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Catheter tip position assessed on chest radiographs immediately after surgery, on postoperative day 1, and on postoperative day 2.
Key secondary outcomes
Postoperative pain assessed using the NRS
Time required to perform the nerve block
Catheter insertion length
Evaluation of catheter position using ultrasound imaging
Presence of complications
Number of rescue analgesic administrations
Total opioid consumption
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
At the end of surgery, an ultrasound-guided serratus anterior plane block was performed. A 17gauge Tuohy needle was used for needle insertion, and an initial bolus of 3 mL of 0.25% levobupivacaine was administered. After placement of the catheter (Arrow FlexTip Plus, Teleflex, PA, USA), an additional 37 mL of 0.25% levobupivacaine was injected. Following catheter placement, intermittent bolus administration of 6 mL of 0.25% levobupivacaine was performed every hour, with a total volume of 300 mL. During intubation, fentanyl was continuously infused at a rate of 0.3 mcg/kg/h. The fentanyl infusion was discontinued after extubation. Pain intensity was assessed using the NRS every 6 hours. Rescue analgesics were administered upon patient request.
Interventions/Control_2
At the end of surgery, an ultrasound-guided serratus anterior plane block was performed. A 17gauge Tuohy needle was used for needle insertion, and an initial bolus of 40 mL of 0.25% levobupivacaine was administered. A catheter (Arrow FlexTip Plus, Teleflex, PA, USA) was then inserted.Following catheter placement, intermittent bolus administration of 6 mL of 0.25% levobupivacaine was performed every hourwith a total volume of 300 mL. During intubation, fentanyl was continuously infused at a rate of 0.3 mcg/kg/h. The fentanyl infusion was discontinued after extubation. Pain intensity was assessed using the NRS every 6 hours. Rescue analgesics were administered upon patient request.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients scheduled for elective minimally invasive cardiac surgery via right lateral thoracotomy
Patients scheduled to receive continuous postoperative analgesia using a serratus anterior plane block
Patients who provided written informed consent after adequate explanation of the study protocol
Key exclusion criteria
Patients with a history of allergy or hypersensitivity to local anesthetics
Patients with chronic opioid use
Patients with a body weight <33 kg
Patients with a body mass index >30 kg/m2
Patients with a history of ipsilateral (right-sided) thoracic surgery
Patients with psychiatric or neurological disorders
In addition, patients who required conversion from minimally invasive cardiac surgery to open thoracotomy, or in whom catheter tip position could not be evaluated on chest radiography, were excluded from the final analysis.
Target sample size
44
Research contact person
Name of lead principal investigator
| 1st name | Ayano |
| Middle name | |
| Last name | Toyama |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
330-0834
Address
1-847 Amanuma-cho, Omiya Ward, Saitama City, Saitama Prefecture
TEL
048-647-2111
honda.ayano@jichi.ac.jp
Public contact
Name of contact person
| 1st name | Ayano |
| Middle name | |
| Last name | Toyama |
Organization
Jichi Medical University Saitama Medical Center
Division name
Department of Anesthesiology and Critical Care Medicine
Zip code
330-0834
Address
1-847 Amanuma-cho, Omiya Ward, Saitama City, Saitama Prefecture
TEL
048-647-2111
Homepage URL
honda.ayano@jichi.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care Medicine
Institute
Department
Personal name
Funding Source
Organization
SENKO MEDICAL INSTRUMENT Mfg. CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
the Institutional Review Board of Jichi Medical University Saitama Medical Center
Address
1-847 Amanuma-cho, Omiya Ward, Saitama City, Saitama Prefecture
Tel
048-647-2111
s-suishin@jichi.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 04 | Month | 05 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Enrolling by invitation
Date of protocol fixation
| 2026 | Year | 04 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 04 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 05 | Day |
Last follow-up date
| 2028 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 04 | Month | 04 | Day |
Last modified on
| 2026 | Year | 04 | Month | 04 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069987
