UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035841 |
|---|---|
| Receipt number | R000040795 |
| Scientific Title | Comparison of analgesic efficacy of lateral femoral cutaneous nerve block and local infiltration anesthesia after total hip arthroplasty |
| Date of disclosure of the study information | 2019/04/01 |
| Last modified on | 2020/09/28 08:44:44 |
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Basic information
Public title
Comparison of analgesic efficacy of lateral femoral cutaneous nerve block and local infiltration anesthesia after total hip arthroplasty
Acronym
Comparison of analgesic efficacy of lateral femoral cutaneous nerve block and local infiltration anesthesia after total hip arthroplasty
Scientific Title
Comparison of analgesic efficacy of lateral femoral cutaneous nerve block and local infiltration anesthesia after total hip arthroplasty
Scientific Title:Acronym
Comparison of analgesic efficacy of lateral femoral cutaneous nerve block and local infiltration anesthesia after total hip arthroplasty
Region
| Japan |
Condition
Condition
The patients who undergo total hip arthroplasty
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It aims to compare postoperative analgesic effect of lateral femoral cutaneous nerve block and local infiltration anesthesia in total hip arthroplasty
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Numerical rating scale of end of surgery and 1,3,6,12,18 and 24 hours after surgery
Key secondary outcomes
Nausea and vomiting 24 hours after surgery
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -but assessor(s) 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
All patients were anesthetized under total intravenous anesthesia with propofol and remifentanil. After induction of anesthesia, patients received a femoral nerve block using 20ml of 0.25% levobupivacaine and a lateral femoral cutaneous nerve block using 20ml of 0.25% levobupivacaine. All patients received bolus administration of 0.25mg fentanyl 30 min before the end of surgery and 0.25mg fentanyl at skin closure. They received 1000mg acetaminophen intravenously at end of surgery, and 6, 12, 18 and 24 hours postoperatively. Postoperative pain was evaluated by nursing staffs using a numerical rating scale (NRS) at 0, 1, 3, 6, 12, 18 and 24 hours postoperatively. Frequency of use of rescue analgesics and consumption of rescue analgesics were recorded for 12 and 24 hours after surgery.
Interventions/Control_2
All patients were anesthetized under total intravenous anesthesia with propofol and remifentanil. After induction of anesthesia, patients received a femoral nerve block using 20ml of 0.25% levobupivacaine. All patients received bolus administration of 0.25mg fentanyl 30 min before the end of surgery and 0.25mg fentanyl at skin closure. At the time of skin closure the surgeon injected 20 ml of 0.25% levobupivacaine around the skin incision.They received 1000mg acetaminophen intravenously at end of surgery, and 6, 12, 18 and 24 hours postoperatively. Postoperative pain was evaluated by nursing staffs using a numerical rating scale (NRS) at 0, 1, 3, 6, 12, 18 and 24 hours postoperatively. Frequency of use of rescue analgesics and consumption of rescue analgesics were recorded for 12 and 24 hours after 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients weighing 50-70 kg and undergoing elective total hip arthroplasty
Key exclusion criteria
1. ASA physical status 3-6
2. Liver dysfunction
3. Allergy to acetaminophen or local anesthetics
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Ayako |
| Middle name | |
| Last name | Shimasaki |
Organization
Nagasaki Rosai Hospital
Division name
Department of anesthesia
Zip code
8570016
Address
2-12-5, Setogoe, Sasebo, Nagasaki, Japan
TEL
0956-49-2191
neko-maru178@hotmail.co.jp
Public contact
Name of contact person
| 1st name | Ayako |
| Middle name | |
| Last name | Shimasaki |
Organization
Nagasaki Rosai Hospital
Division name
Department of anesthesia
Zip code
8570016
Address
2-12-5, Setogoe, Sasebo, Nagasaki, Japan
TEL
0956-49-2191
Homepage URL
neko-maru178@hotmail.co.jp
Sponsor or person
Institute
Nagasaki Rosai 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
Nagasaki Rosai Hospital
Address
2-12-5, Setogoe, Sasebo, Nagasaki, Japan
Tel
0956-49-2191
shomu@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
| 2019 | Year | 04 | 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
50
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 01 | Month | 17 | Day |
Date of IRB
| 2019 | Year | 01 | Month | 17 | Day |
Anticipated trial start date
| 2019 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 03 | 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
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2020 | Year | 09 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040795
