UMIN-CTR Clinical Trial

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