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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042302
Receipt No. R000048295
Scientific Title Efficacy of cocktail analgesic injection to the joint capsule for pain management after total hip arthroplasty
Date of disclosure of the study information 2020/11/02
Last modified on 2020/10/30

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Basic information
Public title Efficacy of cocktail analgesic injection to the joint capsule for pain management after total hip arthroplasty
Acronym cocktail trial
Scientific Title Efficacy of cocktail analgesic injection to the joint capsule for pain management after total hip arthroplasty
Scientific Title:Acronym cocktail trial
Region
Japan

Condition
Condition osteoarthritis
Classification by specialty
Orthopedics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare postoperative pain on a visual analog scale (VAS) between a group of patients who received a cocktail injection into the joint capsule during total hip arthroplasty and a placebo group.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes pain on a VAS at the end of lumbar spine anesthesia (when lower extremity auto-movement and sensation returned), 6 hours, 12 hours, 24 hours, 3 days, 7 days, at discharge, 4 weeks and 12 weeks post-op.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants 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 Triamcinolone acetonide, levobupivacaine
Interventions/Control_2 Betamethasone, levobupivacaine
Interventions/Control_3 saline solution
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 primary total hip arthroplasty
Key exclusion criteria 1) Patients who are difficult to administer lumbar anesthesia
2) Patients requiring total resection of the articular capsule (cases of high dislocation and cases with femoral osteotomy)
3) Patients with poorly controlled diabetic comorbidities and susceptible conditions.
4) Patients with neurological and muscular diseases of the affected limb (e.g., Charcot's joints)
5) Patients with comorbid conditions that may affect consent or assessment, such as dementia, schizophrenia, depression, panic disorder, and generalized anxiety disorder.
6) Patients with a history of allergy to the drugs used in this study.
7) Patients deemed to require lower extremity surgery, including total hip or total knee replacement, within 6 months of participation in this study.
8) Patients who had lower extremity surgery, such as total hip, knee, or osteotomy, in less than 6 months prior to participation in this study.


Translated with www.DeepL.com/Translator (free version)
Target sample size 150

Research contact person
Name of lead principal investigator
1st name Satoshi
Middle name
Last name Ikemura
Organization Kyushu University Hospital
Division name Orthopedic Surgery
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5488
Email sikemura@ortho.med.kyushu-u.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Ikemura
Organization Kyushu University Hospital
Division name Orthopedic Surgery
Zip code 812-8582
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
TEL 092-642-5488
Homepage URL
Email sikemura@ortho.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu Universit
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology (MEXT)
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Kyushu University Certified Institutional Review Board for Clinical Trials
Address 3-1-1 Maidashi, Higashi-ku, Fukuoka
Tel 092-642-5082
Email bynintei@jimu.kyushu-u.ac.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
2020 Year 11 Month 02 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 Preinitiation
Date of protocol fixation
2020 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2021 Year 01 Month 04 Day
Last follow-up date
2022 Year 12 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 10 Month 30 Day
Last modified on
2020 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048295

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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