UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040124 |
|---|---|
| Receipt number | R000045587 |
| Scientific Title | Comparison of the effect on the postoperative pain between infiltration into the posterior capsule and IPACK block after total knee arthroplasty |
| Date of disclosure of the study information | 2020/04/13 |
| Last modified on | 2023/04/14 14:23:00 |
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Basic information
Public title
Comparison of the effect on the postoperative pain between infiltration into the posterior capsule and IPACK block after total knee arthroplasty
Acronym
Comparison between infiltration into the posterior capsule and IPACK block
Scientific Title
Comparison of the effect on the postoperative pain between infiltration into the posterior capsule and IPACK block after total knee arthroplasty
Scientific Title:Acronym
Comparison between infiltration into the posterior capsule and IPACK block
Region
| Japan |
Condition
Condition
Total knee arthroplasty
Classification by specialty
| Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Comparison between infiltration into the posterior capsule and IPACK block in patients undergoing total knee arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1, NRS score (0POD and 1POD)
Key secondary outcomes
1, rescue drug consumption (tatal amount and friquency)(0POD and 1POD)
2, postoperative complication (especially, PONV)(0POD and 1POD)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Infiltration into the posterior capsule with 0.25% levobupivacaine 30ML before cementing
Interventions/Control_2
IPACK block with 0.25% levobupivacaine 30ML before operation
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1,Osteoarthritis of the unilateral knee
2,The patients obtained the written informed consent of participation into this study
Key exclusion criteria
1, A medical history of allergy to local anesthetics.
2, Medication of either opioids or steroid.
3, A neurological disorder affecting the corresponding region.
4, liver or renal dysfunction, medical history of peptic ulcer or asthma
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Yoshiaki |
| Middle name | |
| Last name | Terao |
Organization
Nagasaki Rosai Hospital
Division name
Department of Anesthesia
Zip code
857-0134
Address
2-12-5 Setogoe, Sasebo, Nagasaki, Japan
TEL
0956-49-2191
yoterao@nagasakih.johas.go.jp
Public contact
Name of contact person
| 1st name | YOSHIAKI |
| Middle name | |
| Last name | TERAO |
Organization
Nagasaki Rosai Hospital
Division name
Department of Anesthesia
Zip code
857-0134
Address
2-12-5, Setogoe, Sasebo, Nagasaki, Japan
TEL
+81956492191
Homepage URL
yoterao@nagasakih.johas.go.jp
Sponsor or person
Institute
Department of Anesthesia, Nagasaki Rosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Research funds to promote the hospital functions of Japan Organization of Occupational Health and Safety
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Nagasaki Rosai Hospital
Address
2-12-5 Setogoe, Sasebo, Nagasaki, Japan
Tel
+81956492191
shom@nagasakih.johas.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
長崎労災病院（長崎県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 04 | Month | 13 | 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
Completed
Date of protocol fixation
| 2020 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 03 | Month | 16 | Day |
Anticipated trial start date
| 2020 | Year | 04 | Month | 13 | Day |
Last follow-up date
| 2021 | 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 | 04 | Month | 10 | Day |
Last modified on
| 2023 | Year | 04 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045587
