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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011907
Receipt No. 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

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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
Email 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
Email kdoiepi@gmail.com

Sponsor
Institute National Hospital Organization Hamada Medical Center,Department of Anesthesiology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010294

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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