UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035058 |
|---|---|
| Receipt number | R000039966 |
| Scientific Title | Comparison of programmed intermittent epidural bolus (PIEB) and tapering programmed intermittent epidural bolus (tPIEB) in open abdominal surgery. |
| Date of disclosure of the study information | 2018/12/01 |
| Last modified on | 2021/04/30 10:54:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Comparison of programmed intermittent epidural bolus (PIEB) and tapering programmed intermittent epidural bolus (tPIEB) in open abdominal surgery.
Acronym
PIEB vs tPIEB
Scientific Title
Comparison of programmed intermittent epidural bolus (PIEB) and tapering programmed intermittent epidural bolus (tPIEB) in open abdominal surgery.
Scientific Title:Acronym
PIEB vs tPIEB
Region
| Japan |
Condition
Condition
Patients undergoing open abdominal surgery
Classification by specialty
| Hematology and clinical oncology | 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 programmed intermittent epidural bolus with tapering programmed intermittent epidural bolus, and evaluate the efficacy of postoperative epidural analgesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the degree of postoperative pain (NRS pain scores: 0=no pain to 10=the worst pain imaginable)
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
We administered analgesic agents by programmed intermittent epidural bolus to patients undergoing open abdominal surgery.
Interventions/Control_2
We administered analgesic agents by tapering programmed intermittent epidural bolus to patients undergoing open abdominal 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
American Society of Anesthesiologist Physical Status of I-III. The ages over 20 years old. Patients undergoing open abdominal surgery.
Key exclusion criteria
American Society of Anesthesiologist Physical Status over IV. The ages under 20 years old. Patients who do not agree the participation in the study.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yasuo Tsutsumi |
Organization
Tokushima University
Division name
Department of Anesthesiology
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-7181
tsutsumi@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yasuo Tsutsumi |
Organization
Tokushima University
Division name
Department of Anesthesiology
Zip code
Address
3-18-15 Kuramoto, Tokushima
TEL
088-633-7181
Homepage URL
tsutsumi@tokushima-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Tokushima University
Institute
Department
Personal name
Funding Source
Organization
departmental funding
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
Address
Tel
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
| 2018 | Year | 12 | Month | 01 | 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
Completed
Date of protocol fixation
| 2018 | Year | 11 | Month | 28 | Day |
Date of IRB
| 2018 | Year | 12 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | 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
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2021 | Year | 04 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039966
