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UMIN-CTR Clinical Trial |
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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 |
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 |
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Condition | ||||
Condition | Patients undergoing laparoscopic surgery | |||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 30 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Wakayama Medical University | ||||||
Division name | 2nd Department of Surgery | ||||||
Zip code | |||||||
Address | 811-1, Kimiidera, Wakayama | ||||||
TEL | 073-441-0613 | ||||||
shin-8@wakayama-med.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Wakayama Medical University | ||||||
Division name | 2nd Department of Surgery | ||||||
Zip code | |||||||
Address | 811-1, Kimiidera, Wakayama | ||||||
TEL | 073-441-0613 | ||||||
Homepage URL | |||||||
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 | |
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Tel | |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry |
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Date trial data considered complete |
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Date analysis concluded |
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Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |