UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014506 |
|---|---|
| Receipt number | R000016628 |
| Scientific Title | A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery |
| Date of disclosure of the study information | 2014/07/10 |
| Last modified on | 2015/03/11 01:17:20 |
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Basic information
Public title
A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery
Acronym
A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery
Scientific Title
A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery
Scientific Title:Acronym
A study of the usefulness of under peritoneal swelling anesthesia for analgesia after laparoscopic surgery
Region
| Japan |
Condition
Condition
Patients undergoing laparoscopic surgery
Classification by specialty
| Surgery in general | Gastrointestinal surgery | Hepato-biliary-pancreatic surgery |
| Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the usefulness of under peritoneal swelling anesthesia as postoperative analgesia with conventional management including epidural anesthesia of postoperative pain relief in laparoscopic surgery.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Visual analogue scale of under peritoneal swelling anesthesia as postoperative analgesia conventional management including epidural anesthesia of postoperative pain relief in laparoscopic surgery.
Key secondary outcomes
Analgesic effect (VAS or PHS of up to five days after surgery)
Drug use during surgery, postoperative (type and quantity)
Complications associated with anesthesia
Anesthesia procedure time
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Under peritoneal swelling anesthesia in the intervention group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Age of patients:20 years of age or older at the time of acquisition consent
PS = 0 or 1
patient under peritoneal swelling anesthesia is enforceable
Patients who are undergoing for laparoscopic surgery without incision other than a small incision of the umbilical region(the definition of small incision is less than 5cm, port insertion hole is assumed to be excluded)
After receiving a sufficient explanation upon participation of this study, on a full understanding, patients who obtained the document voluntary consent
Key exclusion criteria
Patients with oral analgesics on regularly
Patients with restrictions on the use of analgesics
Patients with mental illness, alcoholism
Patient for a long time surgery is predicted by adhesion, etc.
Patients who have migrated to open surgery
Patients who principal investigator was deemed inappropriate as a subject
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Satoshi Hirano |
Organization
Hokkaido University Graduate School of Medicene
Division name
Department of Gastroenterological Surgery II
Zip code
Address
Japan, Hokkaido, Sapporo, North15 west5
TEL
011-706-7714
satto@msa.biglobe.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dai Miyazaki |
Organization
Hokkaido University Graduate School of Medicene
Division name
Department of Gastroenterological Surgery II
Zip code
Address
Japan, Hokkaido, Sapporo, North15 west5
TEL
011-706-7714
Homepage URL
dmiyazaki-hok@umin.ac.jp
Sponsor or person
Institute
Hokkaido University Graduate School of Medicene Department of Gastroenterological Surgery II
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
Address
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
北海道大学病院（北海道）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 10 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 08 | Day |
Last modified on
| 2015 | Year | 03 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016628
