UMIN-CTR Clinical Trial

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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