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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000021910 |
Receipt No. | R000025272 |
Scientific Title | The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial |
Date of disclosure of the study information | 2016/04/14 |
Last modified on | 2018/09/21 |
Basic information | ||
Public title | The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial | |
Acronym | The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial | |
Scientific Title | The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial | |
Scientific Title:Acronym | The opportune time for periarticular injection during total knee arthroplasty under general anesthesia: a randomized controlled trial | |
Region |
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Condition | |||
Condition | Osteoarthritis of the knee, rheumatoid arthritis, avascular necrosis | ||
Classification by specialty |
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Classification by malignancy | Others | ||
Genomic information | NO |
Objectives | |
Narrative objectives1 | The aim of this study is to compare the efficacy of periarticular injection between the superficial injection after the implantation of prosthesis and the superficial injection just prior to the arthrotomy in total knee arthroplasty under general anesthesia.
In the both groups, the deep injection is performed just prior to the implantation of prosthesis. |
Basic objectives2 | Safety,Efficacy |
Basic objectives -Others | |
Trial characteristics_1 | |
Trial characteristics_2 | |
Developmental phase |
Assessment | |
Primary outcomes | Pain score (Visual analogue scale) at recovery room |
Key secondary outcomes | Pain score (Visual analogue scale) 3 and 6 hours after surgery and 1 day after surgery
Blood loss Complications The consumption of remifentanil The use of naloxone |
Base | |
Study type | Interventional |
Study design | |
Basic design | Parallel |
Randomization | Randomized |
Randomization unit | Individual |
Blinding | Single blind -participants are blinded |
Control | Active |
Stratification | NO |
Dynamic allocation | NO |
Institution consideration | |
Blocking | NO |
Concealment |
Intervention | |||
No. of arms | 2 | ||
Purpose of intervention | Treatment | ||
Type of intervention |
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Interventions/Control_1 | Superficial injection after the implantation of prosthesis | ||
Interventions/Control_2 | Superficial injection just prior to the arthrotomy | ||
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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Patients scheduled for unilateral total knee arthroplasty | |||
Key exclusion criteria | Patients scheduled for simultaneous bilateral total knee arthroplasty.
Patients who had allergy or intolerance to one of the study drugs, regular narcotic use, renal insufficiency and prolonged QT interval on ECG. |
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Target sample size | 40 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Hokusuikai Kinen Hospital | ||||||
Division name | Orthopaedic surgery | ||||||
Zip code | |||||||
Address | 3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan | ||||||
TEL | 029-303-3003 | ||||||
s8058@nms.ac.jp |
Public contact | |||||||
Name of contact person |
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Organization | Hokusuikai kinen hospital | ||||||
Division name | Orthopaedic surgery | ||||||
Zip code | |||||||
Address | 3-2-1 Higashihara, Mito, Ibaraki, 310-0035 Japan | ||||||
TEL | 029-303-3003 | ||||||
Homepage URL | |||||||
s8058@nms.ac.jp |
Sponsor | |
Institute | Hokusuikai Kinen Hospital |
Institute | |
Department |
Funding Source | |
Organization | Hokusuikai Kinen Hospital |
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 | |
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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 |
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Related information | |
URL releasing protocol | |
Publication of results | Published |
Result | |
URL related to results and publications | https://link.springer.com/article/10.1007%2Fs00167-018-5140-y |
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 | Completed | ||||||
Date of protocol fixation |
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Date of IRB | |||||||
Anticipated trial start date |
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Last follow-up date | |||||||
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Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025272 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |