UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024147 |
|---|---|
| Receipt number | R000027805 |
| Scientific Title | Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial |
| Date of disclosure of the study information | 2016/09/24 |
| Last modified on | 2018/03/28 19:26:12 |
* 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
Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Acronym
Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Scientific Title
Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Scientific Title:Acronym
Comparison of the postoperative analgesic efficacy of intravenous acetaminophen versus ultrasound-guided fascia iliaca compartment block for patients with proximal femoral fracture: a randomized controlled trial
Region
| Japan |
Condition
Condition
proximal femoral fracture
Classification by specialty
| Orthopedics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the postoperative analgesic efficacy of intravenous acetaminophen and fascia iliaca compartment block for patients with proximal femoral fracture
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
pain (until 7days after surgery.)
Key secondary outcomes
the number of rescue dose.
All side effects.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intravenous acetaminophen
6 and 12 hours after surgery
Interventions/Control_2
Fascia iliaca compartment blockade
before spinal anesthesia
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
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients whose American Society of Anesthesiologists Physical Status are 1-2, planned to perform surgery for proximal femoral fracture.
a person who was informed sufficiently, and agree to perticipate this study of one's free will.
Key exclusion criteria
peripheral neuropathy or local anesthetic allergy.
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tomoyuki Danura |
Organization
Unnan City Hospital
Division name
Department of Orthopedic Surgery
Zip code
Address
96-1 Daito-cho Iida, Unnan, Shimane, 699-1221, Japan
TEL
+81-85-443-2390
tomocalcio@blackmail.cn
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Norio Yamamoto |
Organization
Unnan City Hospital
Division name
Department of Orthopedic Surgery
Zip code
Address
96-1 Daito-cho Iida, Unnan, Shimane, 699-1221, Japan
TEL
+81-85-443-2390
Homepage URL
norio-yamamoto@umin.ac.jp
Sponsor or person
Institute
Unnan City Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Address
Tel
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
| 2016 | Year | 09 | Month | 24 | 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
| 2016 | Year | 09 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 09 | Month | 26 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 09 | Month | 24 | Day |
Last modified on
| 2018 | Year | 03 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027805
