UMIN-CTR Clinical Trial

Basic information
Public title	A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Acronym	A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Scientific Title	A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Scientific Title:Acronym	A Study on the Efficacy of Lumbar Plexus Block in Total Hip Arthroplasty
Region	Japan

Condition
Condition	Patients for total hip arthroplasty
Classification by specialty	Orthopedics Anesthesiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of this study is to evaluate the efficacy of postoperative lumbar plexus block in relieving postoperative pain in patients undergoing hip replacement surgery by randomly assigning them to a group with or without lumbar plexus block.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Pain at rest and during movement will be assessed by NRS and compared at 30 minutes, 2 hours, 5 hours, 11 hours, the morning of the first postoperative day, and the morning of the second postoperative day after returning to the ward.
Key secondary outcomes	Presence or absence of motor paralysis and PONV at 30 minutes, 2 hours, 5 hours, 11 hours after returning to the ward, on the morning of the first postoperative day, and on the morning of the second postoperative day, number of times of antiemetic use,number of times rescue was used and time to first use, and patient satisfaction with pain

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Maneuver
Interventions/Control_1	Postoperative lumbar plexus block with 20 ml of 0.15% levobupivacaine in patients undergoing hip replacement surgery.
Interventions/Control_2	No postoperative lumbar plexus block in patients undergoing hip replacement 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	20 years-old <=
Age-upper limit	85 years-old >=
Gender	Male and Female
Key inclusion criteria	ASA-PS 1 or 2
Key exclusion criteria	ASA-PS 3 or higher, not a single operation (e.g. bilateral THA), unobserved withdrawal of antiplatelet/anticoagulant medication, patients with hepatic or renal dysfunction, patients with dementia, patients with allergy to local anesthetics, preoperative opioid use
Target sample size	60

Research contact person
Name of lead principal investigator	1st name Yugo Middle name Last name Ono
Organization	Itabashi Chuo Medical Center
Division name	Department of Anesthesiology
Zip code	174-0051
Address	2-12-7, Azusawa, Itabashi-ku, Tokyo
TEL	03-3967-1181
Email	yugo1201@yahoo.co.jp

Public contact
Name of contact person	1st name Yugo Middle name Last name Ono
Organization	Itabashi Chuo Medical Center
Division name	Department of Anesthesiology
Zip code	174-0051
Address	2-12-7, Azusawa, Itabashi-ku, Tokyo
TEL	03-3967-1181
Homepage URL
Email	yugo1201@yahoo.co.jp

Sponsor
Institute	Itabashi Chuo Medical Center
Institute
Department

Funding Source
Organization	none
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	Itabashi Chuo Medical Center
Address	2-12-7, Azusawa, Itabashi-ku, Tokyo
Tel	03-3967-1181
Email	ikyokuhisyo.ibh@ims.gr.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

Other administrative information
Date of disclosure of the study information	2021 Year 01 Month 25 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	2020 Year 12 Month 22 Day
Date of IRB	2020 Year 12 Month 22 Day
Anticipated trial start date	2020 Year 12 Month 22 Day
Last follow-up date	2022 Year 12 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	2021 Year 01 Month 25 Day
Last modified on	2022 Year 12 Month 11 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049236