UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042302 |
|---|---|
| Receipt number | 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 | 2022/02/15 22:06:45 |
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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
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
sikemura@ortho.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu Universit
Institute
Department
Personal name
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
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
Enrolling by invitation
Date of protocol fixation
| 2020 | Year | 10 | Month | 23 | Day |
Date of IRB
| 2020 | Year | 10 | Month | 23 | Day |
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
| 2022 | Year | 02 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048295
| Research Plan | |
|---|---|
| Registered date | File name |
| 2022/02/15 | 研究計画書 1.5.doc |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
