UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of continuous epidural infusion (CEI) and tapering programmed intermittent epidural bolus (t-PIEB) in open abdominal surgery.
Acronym	CEI vs t-PIEB
Scientific Title	Comparison of continuous epidural infusion (CEI) and tapering programmed intermittent epidural bolus (t-PIEB) in open abdominal surgery.
Scientific Title:Acronym	CEI vs t-PIEB
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 continuous epidural infusion 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 tapering programmed intermittent epidural bolus(t-PIEB) for patient under going open abdominal surgery.
Interventions/Control_2	we administered analgesic agents by continuous epidural infusion(CEI) for patient under going 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 Anesthesiologists Physical State of I-III. the ages over 20 years old. Patients undergoing open abdominal surgery.
Key exclusion criteria	American Society of Anesthesiologists Physical State over IV. the ages under 20 years old. Patients who don not obtain consent.
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 Kumamoto, Tokushima
TEL	088-633-7181
Email	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 Kumamoto, 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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 10 Month 30 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 10 Month 30 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 10 Month 29 Day
Last modified on	2021 Year 04 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039548