UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033472 |
|---|---|
| Receipt number | R000038168 |
| Scientific Title | PAIN control after laparoscopic Surgery using EpiduRal anesthesia Versus Intravenous aCEtaminophen with local anesthesia: an open-label pilot study |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2020/01/28 15:39:43 |
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Basic information
Public title
PAIN control after laparoscopic Surgery using EpiduRal anesthesia Versus Intravenous aCEtaminophen with local anesthesia: an open-label pilot study
Acronym
l-PAIN SERVICE pilot trial
Scientific Title
PAIN control after laparoscopic Surgery using EpiduRal anesthesia Versus Intravenous aCEtaminophen with local anesthesia: an open-label pilot study
Scientific Title:Acronym
l-PAIN SERVICE pilot trial
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the effect of epidural anesthesia and intravenous acetaminophen with local anesthesia for postoperative pain management.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Acelio Intravenous Injection 1000mg with local anesthesia
Interventions/Control_2
Epidural anesthesia with local anesthesia
Interventions/Control_3
local anesthesia
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 including robotic 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)active peptic ulcer
11)Patient with allergy to acetaminophen, opioid or local anesthesia
12)Others
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Shinya |
| Middle name | |
| Last name | Hayami |
Organization
Wakayama Medical University
Division name
2nd Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama
TEL
073-441-0613
shin-8@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Shinya |
| Middle name | |
| Last name | Hayami |
Organization
Wakayama Medical University
Division name
2nd Department of Surgery
Zip code
641-8510
Address
811-1, Kimiidera, Wakayama
TEL
073-441-0613
Homepage URL
shin-8@wakayama-med.ac.jp
Sponsor or person
Institute
Wakayama Medical University
Institute
Department
Personal name
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
Wakayama Medical University
Address
811-1, Kimiidera, Wakayama
Tel
073-441-0613
shin-8@wakayama-med.ac.jp
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 | 08 | 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
No longer recruiting
Date of protocol fixation
| 2018 | Year | 07 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 26 | 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 | 07 | Month | 22 | Day |
Last modified on
| 2020 | Year | 01 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038168
