UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035562 |
|---|---|
| Receipt number | R000040513 |
| Scientific Title | Ultrasound-guided lateral femoral cutaneous nerve block with femoral nerve block versus femoral nerve only for pain control after total hip arthroplasty - a ramdomized, blinded comparison trial - |
| Date of disclosure of the study information | 2019/01/19 |
| Last modified on | 2023/03/06 16:06:29 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Ultrasound-guided lateral femoral cutaneous nerve block with femoral nerve block versus femoral nerve only for pain control after total hip arthroplasty - a ramdomized, blinded comparison trial -
Acronym
Lateral femoral cutaneous nerve block for pain control after total hip arthroplasty
Scientific Title
Ultrasound-guided lateral femoral cutaneous nerve block with femoral nerve block versus femoral nerve only for pain control after total hip arthroplasty - a ramdomized, blinded comparison trial -
Scientific Title:Acronym
Lateral femoral cutaneous nerve block for pain control after total hip arthroplasty
Region
| Japan |
Condition
Condition
Total hip arthroplasty
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparison lateral femoral cutaneous nerve block with femoral nerve block versus femoral nerve block only.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical rating scale after 3hr from a operation.
Key secondary outcomes
A temporal change of NRS after a operation for 48hr.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Lateral femoral cutaneous nerve block and femoral nerve block.
Interventions/Control_2
Femoral nerve block.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Eligible participants were patients scheduled for primary THA.
Key exclusion criteria
Revision arthroplasty, not suitable for puncture of nerve block, allergy against local anaesthetics, over 6hr of anesthesia time, dimentia, necessary of ventilation management after operation.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Sonoko |
| Middle name | |
| Last name | Sakurba |
Organization
Juntendo university Shizuoka hospital
Division name
Anesthesiology / Pain Clinic
Zip code
4102211
Address
1129, Nagaoka, Izunokuni-shi, Shizuoka, JAPAN
TEL
055-948-3111
ssakurab@juntendo.ac.jp
Public contact
Name of contact person
| 1st name | Sonoko |
| Middle name | |
| Last name | Sakuraba |
Organization
Anesthesiology / Pain clinic
Division name
Anesthesiology / Pain clinic
Zip code
4102211
Address
Juntendo University Shizuoka Hospital
TEL
055-948-3111
Homepage URL
ssakurab@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
Juntendo University
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
Juntendo University Shizuoka Hospital GCP center
Address
1129, Nagaoka, Izunokuni-shi, Shizuoka, JAPAN
Tel
055-948-3111
gcpjun@mtc.biglobe.ne.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
順天堂大学医学部付属静岡病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 01 | Month | 19 | 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
109
Results
At 3 hours postoperatively, there was no significant difference in pain at rest or during movement between the two groups (at rest: Z = -1.6814, p = 0.0927; during movement: Z = -0.9677, p = 0.9487). There was no significant difference in pain severity at rest or during movement between the two groups throughout the 48-hour postoperative period.
Results date posted
| 2023 | Year | 03 | Month | 06 | Day |
Results Delayed
| Delay expected |
Results Delay Reason
The paper has been accepted, but a publication date has not yet been set.
Date of the first journal publication of results
Baseline Characteristics
There were no differences in patient demographics between the two groups .
Postoperative complication rates also did not differ between the two groups .
Participant flow
ll study participants provided written informed consent for their participation in the study.
Adverse events
No adverse events occurred.
Outcome measures
Postoperative pain was quantified using the NRS. The primary outcome was defined as NRS scores at rest and on movement 3 h postoperatively, and the secondary outcome as changes in NRS scores up to 48 h postoperatively.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
No longer recruiting
Date of protocol fixation
| 2018 | Year | 11 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 11 | Month | 21 | Day |
Anticipated trial start date
| 2018 | Year | 11 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 08 | Day |
Date of closure to data entry
| 2020 | Year | 06 | Month | 30 | Day |
Date trial data considered complete
| 2020 | Year | 06 | Month | 30 | Day |
Date analysis concluded
| 2022 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 01 | Month | 16 | Day |
Last modified on
| 2023 | Year | 03 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040513
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
