UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011907 |
|---|---|
| Receipt number | R000010294 |
| Scientific Title | Effect of pregabalin on postoperative pain and chronic postsurgical pain |
| Date of disclosure of the study information | 2013/09/30 |
| Last modified on | 2020/10/05 19:53:58 |
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Basic information
Public title
Effect of pregabalin on postoperative pain and chronic postsurgical pain
Acronym
Effect of pregabalin on postoperative pain
Scientific Title
Effect of pregabalin on postoperative pain and chronic postsurgical pain
Scientific Title:Acronym
Effect of pregabalin on postoperative pain
Region
| Japan |
Condition
Condition
inguinal hernia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of perioperative pregabalin on postoperative acute pain, complications, and chronic postsurgical pain in adult inguinal herniorraphy
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Acute postoperative pain score using numerical rating scale (0-10) at after 0, 24, 48 hours postoperatively. ( at rest and movement)
Chronic postsurgical pain at 3 month after the operation
Key secondary outcomes
Postoperative nausea, vomiting and pruitis
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
follow up period two years , intevention group 100 cases, medication pregabalin 75mg
Interventions/Control_2
follow up period two years , control group 100 cases,
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
elective radical surgery for inguinal hernia, ASA1-2
Key exclusion criteria
pregnant, renal dysfunction, pneumonitis, urinary infection, bleed ,clotting disorder
severe cardio-pulmonary dysfuntion
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Katsushi Doi |
| Middle name | |
| Last name | Katsushi Doi |
Organization
National Hospital Organization Hamada Medical Center
Division name
Anesthesiology
Zip code
6978511
Address
777-12 Asai-cho, Hamada Shimane, JAPAN
TEL
0855-25-0505
kdoiepi@gmail.com
Public contact
Name of contact person
| 1st name | Katsushi |
| Middle name | |
| Last name | Doi |
Organization
National Hospital Organization Hamada Medical Center
Division name
Anesthesiology
Zip code
6978511
Address
777-12 Asai-cho, Hamada Shimane, JAPAN
TEL
0855-25-0505
Homepage URL
kdoiepi@gmail.com
Sponsor or person
Institute
National Hospital Organization Hamada Medical Center,Department of Anesthesiology
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
NHO Hamada Medical Center
Address
777-12, Asai-cho, Hamada Shimane
Tel
0855250505
6103sy01@hamada2.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
国立病院機構浜田医療センター（島根県）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 09 | Month | 30 | 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
Open public recruiting
Date of protocol fixation
| 2012 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2013 | Year | 09 | Month | 30 | Day |
Last modified on
| 2020 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010294
