UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000049027 |
|---|---|
| Receipt number | R000055860 |
| Scientific Title | A double-blind, randomized study of the efficacy of tapering programmed intermittent epidural bolus (t-PIEB) in video-assisted thoracic surgery (Pilot study) |
| Date of disclosure of the study information | 2022/09/26 |
| Last modified on | 2024/02/03 21:38:44 |
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Basic information
Public title
A double-blind, randomized study of the efficacy of tapering programmed intermittent epidural bolus (t-PIEB) in video-assisted thoracic surgery (Pilot study)
Acronym
Efficacy of t-PIEB in video-assisted thoracic surgery (Pilot study)
Scientific Title
A double-blind, randomized study of the efficacy of tapering programmed intermittent epidural bolus (t-PIEB) in video-assisted thoracic surgery (Pilot study)
Scientific Title:Acronym
Efficacy of t-PIEB in video-assisted thoracic surgery (Pilot study)
Region
| Japan |
Condition
Condition
Patients undergoing video-assisted thoracic surgery for lung cancer
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The intermittent administration of the agent to the epidural space is compared with the continuous administration, the diffusion of the drug is large, it has been efficiently reported the analgesic effect is obtained at lower doses.We compare a method of continuous epidural infusion with tapering programmed intermittent epidural bolus, and evaluate the efficacy of postoperative epidural analgesia.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Doses of patient-controlled analgesia at 24, 48, and 72 hours postoperatively
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
Postoperative epidural anesthesia with tapering programmed intermittent epidural bolus using a battery-powered infusion pump until 72 hours postoperatively
Interventions/Control_2
Postoperative epidural anesthesia with continuous infusion using a battery-powered infusion pump until 72 hours 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
| 18 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients between 20 and 80 years old.
Patients in American Society of Anesthesiologists Physical State of I-III.
Patients scheduled for elective video-assisted thoracic surgery for lung cancer under general anesthesia with epidural anesthesia.
Patients who can give their written consent to participate in this study.
Key exclusion criteria
Patients with severe diabetes mellitus (HbA1c > 8.4).
Patients whose procedure is changed to thoracotomy during surgery.
Patients with the inadequate effect of epidural anesthesia at the end of general anesthesia.
Patients considered unsuitable by anesthesiologists.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Yasuo |
| Middle name | |
| Last name | Tsutsumi |
Organization
Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3 Kasumi, Minami, Hiroshima
TEL
082-257-5267
yasuo223@hiroshima-u.ac.jp
Public contact
Name of contact person
| 1st name | Shiho |
| Middle name | |
| Last name | Satomi |
Organization
Hiroshima University
Division name
Department of Anesthesiology and Critical Care
Zip code
734-8551
Address
1-2-3 Kasumi, Minami, Hiroshima
TEL
082-257-5267
Homepage URL
yasuo223@hiroshima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology and Critical Care
Hiroshima University
Institute
Department
Personal name
Funding Source
Organization
NA
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
Ethical Committee for Clinical Research of Hiroshima University
Address
1-2-3 Kasumi, Minami, Hiroshima
Tel
082-257-1551
iryo-seisaku@office.hiroshima-u.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
| 2022 | Year | 09 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2022 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 10 | Month | 24 | Day |
Last follow-up date
| 2023 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2022 | Year | 09 | Month | 26 | Day |
Last modified on
| 2024 | Year | 02 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055860
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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