UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000051652 |
|---|---|
| Receipt number | R000058940 |
| Scientific Title | Observational Study of how often patients of different age groups use the Patient-Controlled Analgesia Methods for Epidural Analgesia as a way to manage Postoperative Pain after Laparoscopic Cholecystectomy |
| Date of disclosure of the study information | 2023/07/23 |
| Last modified on | 2025/01/18 18:59:51 |
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Basic information
Public title
Investigation of how often patients of different age groups use the Patient-Controlled Analgesia Methods for Epidural Analgesia as a way to manage Postoperative Pain after Laparoscopic Cholecystectomy
Acronym
Survey of Patient-Controlled Epidural Analgesia Use for Postoperative Pain after Laparoscopic Cholecystectomy by Age Group
Scientific Title
Observational Study of how often patients of different age groups use the Patient-Controlled Analgesia Methods for Epidural Analgesia as a way to manage Postoperative Pain after Laparoscopic Cholecystectomy
Scientific Title:Acronym
Observational Study of Patient-Controlled Epidural Analgesia Use for Postoperative Pain after Laparoscopic Cholecystectomy by Age Group
Region
| Japan |
Condition
Condition
Pain after laparoscopic cholecystectomy
Classification by specialty
| Surgery in general | Hepato-biliary-pancreatic surgery | Anesthesiology |
| Operative medicine | Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Survey on the utilization rate of patient-controlled analgesic methods by age group
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Survey of Patient-Controlled Epidural Analgesia Use for Postoperative Pain after Laparoscopic Cholecystectomy by Age Group
Key secondary outcomes
Actual state of analgesia and adverse effects of patient-controlled epidural analgesia for postoperative pain after laparoscopic cholecystectomy
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Survey period: 10 years from 1.1.2013 to 12.31.2022.
Subjects: Among laparoscopic cholecystectomies performed at our hospital, including emergency surgeries,
patients were managed under general anesthesia plus epidural anesthesia, and postoperative analgesia was mainly provided by epidural anesthesia.
PCA status was recorded on the Coopdech Counter only in cases where a Coodech Balloonjector with PCA was used in this epidural analgesia procedure.
Key exclusion criteria
Laparotomy is excluded. General anesthesia maintenance was limited to desflurane, remifentanil, and rocuronium bromide, with other anesthetic methods excluded. Cases in which epidural anesthesia was not performed throughout the intraoperative and postoperative periods were excluded. Epidural analgesic areas were measured on the morning of the day following surgery, and cases with no apparent epidural analgesia, or cases of complete unilateral analgesia, or cases of what appeared to be dural perforation, as well as cases in which no rounds could be made on the morning of the day following surgery were also excluded.
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Tadateru |
| Middle name | |
| Last name | SAWAMURA |
Organization
National Hospital Organization Higashi-Ohmi General Medical Center
Division name
Department of Pharmacology
Zip code
527-8505
Address
255 Gochi-cho, Higashioumi, Shiga, Japan
TEL
0748-22-3030
sawamura.tadateru.ym@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yoshihisa |
| Middle name | |
| Last name | FUJINO |
Organization
National Hospital Organization Higashi-Ohmi General Medical Center
Division name
Department of Anesthesiology
Zip code
527-8505
Address
255 Gochi-cho, Higashioumi, Shiga, Japan
TEL
0748-22-3030
Homepage URL
yfujino@iris.eonet.ne.jp
Sponsor or person
Institute
National Hospital Organization Higashi-Ohmi General Medical Center
Institute
Department
Personal name
Funding Source
Organization
None
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
National Hospital Organization Higashi-Ohmi General Medical Center Ethical Committee
Address
255 Gochi-cho, Higashioumi, Shiga, Japan
Tel
0748-22-3030
402-higashiomishomu@mail.hosp.go.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
| 2023 | Year | 07 | Month | 23 | 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
No longer recruiting
Date of protocol fixation
| 2023 | Year | 07 | Month | 23 | Day |
Date of IRB
| 2023 | Year | 06 | Month | 26 | Day |
Anticipated trial start date
| 2023 | Year | 07 | Month | 23 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2024 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2024 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 06 | Month | 30 | Day |
Other
Other related information
Analysis of our existing medical information
Management information
Registered date
| 2023 | Year | 07 | Month | 19 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058940
