UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000036574 |
|---|---|
| Receipt number | R000041671 |
| Scientific Title | A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery |
| Date of disclosure of the study information | 2019/05/01 |
| Last modified on | 2022/04/24 17:06:16 |
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Basic information
Public title
A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery
Acronym
A randomized prospective study of two different infusion protocol of ultrasound-guided erector spinae plane block
Scientific Title
A randomized prospective comparison of programmed intermittent bolus with continuous infusion for ultrasound-guided erector spinae plane block in video-assisted thoracic surgery
Scientific Title:Acronym
A randomized prospective study of two different infusion protocol of ultrasound-guided erector spinae plane block
Region
| Japan |
Condition
Condition
Lung tumor
Classification by specialty
| Chest surgery | Anesthesiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verifying the difference of anesthetized dermatomes between two different drug infusion protocol for ultrasound-guided erecor spinae plane block in video-assisted thoracic surgery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The number of anesthetized dermatomes
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Device,equipment |
Interventions/Control_1
Using programmed intermittent bolus infusion postoperatively
Interventions/Control_2
Using continuous infusion postoperatively
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.Provided written informed consent
2.American Society of Anesthesiologists physical status 1-3
3.Scheduled to undergo complete video-assisted thoracoscopic surgery for lung cancer.
Key exclusion criteria
allergy to local anesthetics
BMI>30
age< 20 or >80
Liver function disorder
Renal function disorder (eGFR<50)
History of past ipsilateral thoracotomy
Normally using opioid analgesics
Treated mental or neurological disorders
Allergy to acetaminophen, NSAIDs, and fentanyl.
Difficulty in adequate verbal communication
Thoracotomy with rib cutting or pleurectomy
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Taro |
| Middle name | |
| Last name | Fujitani |
Organization
Ehime Prefectural Central Hospital
Division name
Department of Anesthesiology and Critical Care
Zip code
790-0024
Address
83 Kasuga-machi Matsuyama Ehime Japan 790-0024
TEL
089-947-1111
suko1231@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yasuko |
| Middle name | |
| Last name | Taketa |
Organization
Ehime Prefectural Cenral Hospital
Division name
Department of Anesthesia and Critical Care
Zip code
790-0024
Address
83 Kasuga-machi Matsuyama Ehime Japan 790-0024
TEL
089-947-1111
Homepage URL
suko1231@yahoo.co.jp
Sponsor or person
Institute
Ehime Prefectural Central Hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional review board of Ehime Prefectural Central Hospital
Address
83 Kasuga-machi Matsuyama Ehime Japan 790-0024
Tel
089-947-1111
suko1231@yahoo.co.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
| 2019 | Year | 05 | Month | 01 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041671
Publication of results
Unpublished
Result
URL related to results and publications
https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041671
Number of participants that the trial has enrolled
50
Results
The number of dermatomes desensitized in the midclavicular line was significantly higher in group P than in group C (p<0.001). The amount of rescue morphine consumed in the early postoperative period (0-24h) was significantly lower in group P (p=0.035). No significant difference in postoperative numerical rating scale score was found between the groups.
Results date posted
| 2021 | Year | 05 | Month | 08 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
we enrolled those with American Society of Anesthesiologists physical status 1-3 who were scheduled to undergo video-assisted lobectomy for lung cancer between June 2019 and March 2020. Patients who met the following criteria were excluded: inability to provide consent, aged <20 or >80 years, body mass index >30 kg/m2, coagulopathy, history of thoracotomy or breast surgery, use of opioid analgesics, mental or neurological disorders, allergy to perioperative medications, bronchial asthma, impaired renal function with estimated glomerular filtration rate <50 mL/min, and scheduled thoracotomy with rib cutting or pleurectomy.
Participant flow
After obtaining written informed consent from the patients, we enrolled the participants.
Adverse events
No adverse events, such as allergy to local anesthetics, pneumothorax, hematoma, or nerve injury during the study period, were observed.
Outcome measures
The primary outcome was the number of desensitized dermatomes in the midclavicular line. The secondary outcomes were the number of desensitized dermatomes in the paraspinal, anterior axillary, and parasternal regions; numerical rating scale (NRS) score at rest and during movement; total rescue morphine consumption at 0-24 and 24-48 h postoperatively; and postoperative nausea and vomiting (PONV) frequency.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Main results already published
Date of protocol fixation
| 2019 | Year | 04 | Month | 24 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
At the time of protocol registration, the primary endpoint of this study was "the number of anesthetized dermatomes at 20 hours after the initial administration," but because this time point would be affected by the bolus timing in the PIB group, the measurement time was changed to 21 hours after the initial administration before starting the study. In addition, the description of the endpoints was changed because it was necessary to include data 5 hours after the first dose for statistical analysis.
Management information
Registered date
| 2019 | Year | 04 | Month | 22 | Day |
Last modified on
| 2022 | Year | 04 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041671
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
