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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000026025
Receipt No. R000029114
Scientific Title PAIN control after laparoscopic Surgery using EpiduRal anesthesia Versus Intravenous aCEtaminophen: an open-label pilot study
Date of disclosure of the study information 2017/02/08
Last modified on 2019/02/06

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Basic information
Public title PAIN control after laparoscopic Surgery using EpiduRal anesthesia Versus Intravenous aCEtaminophen: an open-label pilot study
Acronym PAIN SERVICE pilot trial
Scientific Title PAIN control after laparoscopic Surgery using EpiduRal anesthesia Versus Intravenous aCEtaminophen: an open-label pilot study
Scientific Title:Acronym PAIN SERVICE pilot trial
Region
Japan

Condition
Condition Patients undergoing laparoscopic surgery
Classification by specialty
Gastrointestinal surgery Hepato-biliary-pancreatic surgery Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the effect of epidural anesthesia and intravenous acetaminophen for postoperative pain management.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The amount of patient-controlled anesthesia for breakthrough analgesia at postoperative 72 hours
Key secondary outcomes VAS(visual analogue scale)
adverse effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Acelio Intravenous Injection 1000mg
Interventions/Control_2 Epidural anesthesia
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

Not applicable
Gender Male and Female
Key inclusion criteria 1)Patients undergoing laparoscopic surgery
i)gastrectomy
ii)colorectal surgery
iii)hepato-biliary-pancreatic(HBP) surgery
2)The age of patients >= 20 years
Key exclusion criteria 1)Epidural catheter can not to be inserted technically
2)Platelet counts <= 100,000
3)Bleeding tendency
4)Patients who can not express their pain (can not use patient-controlled anesthesia)
5)Patients with severe comorbidity(heart failure, renal failure, psychiatric disorder and so on)
6)Transaminase(AST, ALT) >= twofold more than normal limits
7)Patients who took another oral analgesic within preoperative 8 hours
8)Pregnancy or breast-feeding women
9)Aspirin-induced asthma
10)Patient with allergy to acetaminophen, opioid or local anesthesia
11)Others
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masaki Ueno
Organization Wakayama Medical University
Division name 2nd Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama
TEL 073-441-0613
Email shin-8@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shinya Hayami
Organization Wakayama Medical University
Division name 2nd Department of Surgery
Zip code
Address 811-1, Kimiidera, Wakayama
TEL 073-441-0613
Homepage URL
Email shin-8@wakayama-med.ac.jp

Sponsor
Institute Wakayama Medical University
Institute
Department

Funding Source
Organization Wakayama Medical University
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
2017 Year 02 Month 08 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2016 Year 12 Month 21 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 16 Day
Last follow-up date
2017 Year 12 Month 31 Day
Date of closure to data entry
2017 Year 12 Month 31 Day
Date trial data considered complete
2017 Year 12 Month 31 Day
Date analysis concluded
2018 Year 08 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 02 Month 07 Day
Last modified on
2019 Year 02 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029114

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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