UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032735 |
|---|---|
| Receipt number | R000037318 |
| Scientific Title | Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl. |
| Date of disclosure of the study information | 2018/05/28 |
| Last modified on | 2023/12/10 12:43:28 |
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Basic information
Public title
Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Acronym
Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Scientific Title
Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Scientific Title:Acronym
Comparison of the effects of analgesia for patients undergoing laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Region
| Japan |
Condition
Condition
Patients scheduled for elective laparoscopic hepatectomy
Classification by specialty
| Hepato-biliary-pancreatic surgery | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to compare the effects of analgesia for patients scheduled for elective laparoscopic hepatectomy:epidural versus continuous infusion of fentanyl.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
MPADSS(modified post-anaesthesia discharge scoring system)scores for the first 42 postoperative hours.
Key secondary outcomes
Pain scores at rest and while coughing for the first 42 postoperative hours.
Additional analgesics.
The number of PCA bolus.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Epidural analgesia after laparoscopic hepatectomy
Interventions/Control_2
Continuous intravenous fentanyl analgesia after laparoscopic hepatectomy
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
Man and women over 20year old
Patients scheduled for laparoscopic hepatectomy
Key exclusion criteria
Open hepatectomy
Decision as ineligible by principal anaesthesiologist.
Patients with parkinson disease.
Contraindication for any of the drugs used in this study.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Azusa |
| Middle name | |
| Last name | Mori |
Organization
Ikeda City Hospital
Division name
Department of Anesthesiology
Zip code
5638510
Address
3-1-18,Jyonan,Ikeda City ,Osaka,Japan
TEL
0727512881
azuazumorimori@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Azusa |
| Middle name | |
| Last name | Mori |
Organization
Ikeda City Hospital
Division name
Department of Anesthesiology
Zip code
5638510
Address
3-1-18,Jyonan,Ikeda City ,Osaka,Japan
TEL
0727512881
Homepage URL
azuazumorimori@yahoo.co.jp
Sponsor or person
Institute
Ikeda City Hospital
Institute
Department
Personal name
Funding Source
Organization
Ikeda City Hospital
Organization
Division
Category of Funding Organization
Local Government
Nationality of Funding Organization
Other related organizations
Co-sponsor
none
Name of secondary funder(s)
none
IRB Contact (For public release)
Organization
Ikeda City Hospital
Address
3-1-18,Jyonan,Ikeda City ,Osaka,Japan
Tel
0727512881
keiko-irishio@hosp.ikeda.osaka.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 | 05 | Month | 28 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
46
Results
MPADSS score were similar among two groups
Results date posted
| 2023 | Year | 01 | Month | 23 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
patients scheduled for elective laparoscopic hepatectomy
Participant flow
We prospectively evaluated the effect of intravenous fentanyl analgesia with preoperatively single nerve block(n19)compared with the effect of epidural analgesia(n18)
Adverse events
none
Outcome measures
the score of MPADSS(modified
post-anesthesia discharge scoring system) after surgery
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 29 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 05 | Month | 27 | Day |
Last modified on
| 2023 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037318
