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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040081
Receipt No. R000045705
Scientific Title Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.
Date of disclosure of the study information 2020/04/07
Last modified on 2020/06/20

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Basic information
Public title Treatment of Renal Colic Using intradermal Injection of Sterile Water
Acronym ARC
Scientific Title Intradermal sterile water injection versus diclofenac sodium in acute renal colic pain: A randomized controlled trial.
Scientific Title:Acronym ISWARC
Region
Asia(except Japan)

Condition
Condition Acute renal colic
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the intracutaneous injection of sterile water in the treatment of renal colic.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The primary outcome was the improvement in pain intensity using the visual analogue scale at 30min, 45min, and 60min after ISWI ( intradermal sterile water injection), Diclofenac, Placebo injections
Key secondary outcomes The secondary outcome was the need for rescue analgesia after each modality of therapy.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 The control group( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5cc isotonic saline in the flank once.
Interventions/Control_2 Group A ( 50 patients presented to the emergency department with renal colic) received intracutaneous injections of 0.5 cc sterile water in the most painful area of the flank once.
Interventions/Control_3 Group B ( 50 patients presented to the emergency department with renal colic ) received an intramuscular injection of 75 mg diclofenac in the gluteal region once.
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
18 years-old <=
Age-upper limit
60 years-old >=
Gender Male and Female
Key inclusion criteria Patients presented to the emergency department with acute renal colic, confirmed later on to have ureteral stone on unenhanced Computed tomography (CT scan)
Key exclusion criteria Patients who had an infection in the area of injection, patients more than 60 years old, patients who have received any analgesic before presentation
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Athanasios
Middle name
Last name Papatsoris
Organization Sismanoglio Hospital.
Division name Urology
Zip code 15126
Address Athens, Greece
TEL 00302132058001
Email agpapatsoris@yahoo.gr

Public contact
Name of contact person
1st name Mohamad
Middle name
Last name Abou Chakra
Organization Lebanese University
Division name Urology
Zip code 1108
Address Beirut,Lebanon
TEL 009611850040ext.3364
Homepage URL
Email mohamedabouchakra@hotmail.com

Sponsor
Institute Al Zahraa Hospital, University Medical Center, Urology Department
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 Al Zahraa Hospital, University Medical Center
Address Beirut,Lebanon
Tel 009611850040ext.3366
Email uro.ul@outlook.com

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
2020 Year 04 Month 07 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications 10.1016/j.ajem.2020.04.079
Number of participants that the trial has enrolled 150
Results published
Results date posted
2020 Year 04 Month 06 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
2020 Year 04 Month 29 Day
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2017 Year 12 Month 05 Day
Date of IRB
2017 Year 12 Month 12 Day
Anticipated trial start date
2017 Year 12 Month 15 Day
Last follow-up date
2019 Year 12 Month 10 Day
Date of closure to data entry
2019 Year 12 Month 19 Day
Date trial data considered complete
2019 Year 12 Month 20 Day
Date analysis concluded
2020 Year 01 Month 18 Day

Other
Other related information

Management information
Registered date
2020 Year 04 Month 07 Day
Last modified on
2020 Year 06 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045705

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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