UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041814 |
|---|---|
| Receipt number | R000047496 |
| Scientific Title | Efficacy of serratus anterior plane block for postoperative analgesia in Minimally Invasive Cardiac Surgery: a randomized, double-blind, controlled trial |
| Date of disclosure of the study information | 2020/09/16 |
| Last modified on | 2024/03/21 12:30:43 |
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Basic information
Public title
Efficacy of serratus anterior plane block for postoperative analgesia in Minimally Invasive Cardiac Surgery
Acronym
Efficacy of serratus anterior plane block for postoperative analgesia in Minimally Invasive Cardiac Surgery
Scientific Title
Efficacy of serratus anterior plane block for postoperative analgesia in Minimally Invasive Cardiac Surgery: a randomized, double-blind, controlled trial
Scientific Title:Acronym
Efficacy of serratus anterior plane block for postoperative analgesia in Minimally Invasive Cardiac Surgery: a randomized, double-blind, controlled trial
Region
| Japan |
Condition
Condition
Surgical pain after Minimally Invasive Cardiac Surgery
Classification by specialty
| Anesthesiology | Cardiovascular surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of the present study is to evaluate the effect of serratus anterior plane block in the patients who underwent Minimally Invasive Cardiac Surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fentanyl consumption in the first 5 days after surgery
Key secondary outcomes
1.Numerical rating pain scale at rest and moving
2.Length of intensive care unit stay
3.Length of hospital stay
4.Serum concentrartion of ropivacaine
5.Serum concentrartion of fentanyl
6.Short Physical Performance Battery score, walking distance for 6 minutes, grip strength, perimeter of the thorax, range of motion angle at the upper limb joint
7.Incidence of nausea and vomitting
8.Incidence of ropivacaine-induced adverse events
9.Number of use of additional analgesics
10.Time to the first use of fentanyl in intavenouse patient-controlled analgesia
11.Time from discontinuation of fentanyl administration during mechanical ventilation to reinitiation of fentanyl administration for analgesia
12.Transthoracic echocardiography before and after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
Twenty mL of 0.9% saline administration through the catheter for the serratus anterior plane block at 6-hour interval to 5 days after surgery
Interventions/Control_2
Twenty mL of 0.25% ropivacaine administration through the catheter for the serratus anterior plane block at 6-hour interval to 5 days after surgery
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Elective patient who undergo Minimally Invasive Cardiac Surgery with lateral thoracic approach
2.ECOG performance status 0-2
Key exclusion criteria
1.History of thoracotomy
2.History of cardiac surgery
3.Long-term use of opioids
4.Use of analgesic more than 2 months
5.Allergy to local anesthetics
6.Liver failure, renal insufficiency
7.Infection at the block site
8.Pregnancy
9.Phsychiatric disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | YUNA |
| Middle name | |
| Last name | SATO |
Organization
Sendai Kousei Hospital
Division name
Department of Anesthesiology
Zip code
980-0873
Address
4-15 Hirosemachi, Aoba-ku, Sendai, Miyagi
TEL
022-222-6181
y0u1n0a4@gmail.com
Public contact
Name of contact person
| 1st name | YUNA |
| Middle name | |
| Last name | SATO |
Organization
Sendai Kousei Hospital
Division name
Department of Anesthesiology
Zip code
980-0873
Address
4-15 Hirosemachi, Aoba-ku, Sendai, Miyagi
TEL
022-222-6181
Homepage URL
y0u1n0a4@gmail.com
Sponsor or person
Institute
Department of Anesthesiology, Sendai Kousei Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Sendai Kousei Hospital
Address
4-15 Hirosemachi, Aoba-ku, Sendai, Miyagi
Tel
022-222-6181
info@sendai-kousei-hospital.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
| 2020 | Year | 09 | Month | 16 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2020 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 16 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2024 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 09 | Month | 16 | Day |
Last modified on
| 2024 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047496
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