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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000035841
Receipt No. 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

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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
Email 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
Email neko-maru178@hotmail.co.jp

Sponsor
Institute Nagasaki Rosai Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040795

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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