UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043129 |
|---|---|
| Receipt number | R000049236 |
| Scientific Title | A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty |
| Date of disclosure of the study information | 2021/01/25 |
| Last modified on | 2022/12/11 18:59:39 |
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Basic information
Public title
A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Acronym
A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Scientific Title
A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Scientific Title:Acronym
A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Region
| Japan |
Condition
Condition
Patients for total hip arthroplasty
Classification by specialty
| Orthopedics | Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to evaluate the efficacy of postoperative lumbar plexus block in relieving postoperative pain in patients undergoing hip replacement surgery by randomly assigning them to a group with or without lumbar plexus block.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain at rest and during movement will be assessed by NRS and compared at 30 minutes, 2 hours, 5 hours, 11 hours, the morning of the first postoperative day, and the morning of the second postoperative day after returning to the ward.
Key secondary outcomes
Presence or absence of motor paralysis and PONV at 30 minutes, 2 hours, 5 hours, 11 hours after returning to the ward, on the morning of the first postoperative day, and on the morning of the second postoperative day, number of times of antiemetic use,number of times rescue was used and time to first use, and patient satisfaction with pain
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Postoperative lumbar plexus block with 20 ml of 0.15% levobupivacaine in patients undergoing hip replacement surgery.
Interventions/Control_2
No postoperative lumbar plexus block in patients undergoing hip replacement surgery.
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
| 85 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
ASA-PS 1 or 2
Key exclusion criteria
ASA-PS 3 or higher, not a single operation (e.g. bilateral THA), unobserved withdrawal of antiplatelet/anticoagulant medication, patients with hepatic or renal dysfunction, patients with dementia, patients with allergy to local anesthetics, preoperative opioid use
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Yugo |
| Middle name | |
| Last name | Ono |
Organization
Itabashi Chuo Medical Center
Division name
Department of Anesthesiology
Zip code
174-0051
Address
2-12-7, Azusawa, Itabashi-ku, Tokyo
TEL
03-3967-1181
yugo1201@yahoo.co.jp
Public contact
Name of contact person
| 1st name | Yugo |
| Middle name | |
| Last name | Ono |
Organization
Itabashi Chuo Medical Center
Division name
Department of Anesthesiology
Zip code
174-0051
Address
2-12-7, Azusawa, Itabashi-ku, Tokyo
TEL
03-3967-1181
Homepage URL
yugo1201@yahoo.co.jp
Sponsor or person
Institute
Itabashi Chuo Medical Center
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Itabashi Chuo Medical Center
Address
2-12-7, Azusawa, Itabashi-ku, Tokyo
Tel
03-3967-1181
ikyokuhisyo.ibh@ims.gr.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
| 2021 | Year | 01 | Month | 25 | 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 | 12 | Month | 22 | Day |
Date of IRB
| 2020 | Year | 12 | Month | 22 | Day |
Anticipated trial start date
| 2020 | Year | 12 | Month | 22 | 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
| 2021 | Year | 01 | Month | 25 | Day |
Last modified on
| 2022 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049236
