UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050920 |
|---|---|
| Receipt number | R000058041 |
| Scientific Title | The best way to postoperative analgesia for Total Hip Arthroplasty |
| Date of disclosure of the study information | 2023/05/01 |
| Last modified on | 2023/04/25 10:33:28 |
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Basic information
Public title
The best way to postoperative analgesia for Total Hip Arthroplasty
Acronym
The best way to postoperative analgesia for Total Hip Arthroplasty
Scientific Title
The best way to postoperative analgesia for Total Hip Arthroplasty
Scientific Title:Acronym
The best way to postoperative analgesia for Total Hip Arthroplasty
Region
| Japan |
Condition
Condition
hip osteoarthritis
Classification by specialty
| Orthopedics | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to determine which is better to postoperative analgesia for Total Hip Arthroplasty under generarl anesthesia ,spinal anaesthesia with ajunctive intrathecal morphine or fentanyl-based intravenous Patient-controlled analgesia, having a significant analgesic effect and fewer side effects.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Visual analogue scale:VAS during postoperative 2days. admission room, 1h, 4h, 8h, 16h, 40h, after surgery
Key secondary outcomes
with or without nausea and itching during postoperative 2days. admission room, 1h, 4h, 8h, 16h, 40h, after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine | Maneuver |
Interventions/Control_1
group A : under general anesthesia , subarachnoid bupivacaine 0.5% 3 ml and morphine hydrochloride 0.2mg were administered at the L3/4 or L4/5 interspace.
Interventions/Control_2
groupB : intraoperative given interavenous fentanil 5~6ug/kg. Postoperatively, started IV-PCA( intravenous patient controlled analgesia) for 35h.(1~2ug/kg/h, when having pain , given 1~2ug/kg, lock out time 30min)
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
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
patients scheduled to undergo elective Total Hip Arthroplasty under general anesthesia
Key exclusion criteria
previous surgery of lumbar spinal surgery, paralysis of the lower extremities, major neurocognitive disorder, an allergy to bupivacaine or fentanil, morphine hydrochloride
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Usukura |
Organization
Yawata Medical center
Division name
Department of Anesthesiology
Zip code
9238551
Address
12-7 Yawatai,Komatushi,Ishikawa,JAPAN 923-8551
TEL
0761-47-1212
aiai_mats@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Usukura |
Organization
Yawata Medical center
Division name
Department of Anesthesiology
Zip code
9238551
Address
12-7 Yawatai,Komatushi,Ishikawa,JAPAN 923-8551
TEL
0761-47-1212
Homepage URL
aiai_mats@yahoo.co.jp
Sponsor or person
Institute
Yawata Medical center
Institute
Department
Personal name
Ai Usukura
Funding Source
Organization
Yawata Medical center
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Yawata Medical center
Address
12-7 Yawatai,Komatushi,Ishikawa,JAPAN 923-8551
Tel
0761-47-1212
hosp@katuki-g.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
やわたメディカルセンター
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 05 | Month | 01 | 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
40
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
| 2021 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 10 | 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
| 2023 | Year | 04 | Month | 25 | Day |
Last modified on
| 2023 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000058041
