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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000035058
Receipt No. R000039966
Official scientific title of the study 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 2018/11/28

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Basic information
Official scientific title of the study Comparison of programmed intermittent epidural bolus (PIEB) and tapering programmed intermittent epidural bolus (tPIEB) in open abdominal surgery.
Title of the study (Brief title) 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 Yasuo Tsutsumi
Organization Tokushima University
Division name Department of Anesthesiology
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7181
Email tsutsumi@tokushima-u.ac.jp

Public contact
Name of contact person Yasuo Tsutsumi
Organization Tokushima University
Division name Department of Anesthesiology
Address 3-18-15 Kuramoto, Tokushima
TEL 088-633-7181
Homepage URL
Email tsutsumi@tokushima-u.ac.jp

Sponsor
Institute Department of Anesthesiology, Tokushima University
Institute
Department

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)

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

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 11 Month 28 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2018 Year 11 Month 28 Day
Last modified on
2018 Year 11 Month 28 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039966

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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