UMIN-CTR Clinical Trial

Basic information
Public title	Postoperative recovery after anterior quadratus lumborum block for laparoscopic nephrectomy -Assessment of quadriceps muscle strength-
Acronym	Postoperative recovery after anterior quadratus lumborum block for laparoscopic nephrectomy -Assessment of quadriceps muscle strength-
Scientific Title	Postoperative recovery after anterior quadratus lumborum block for laparoscopic nephrectomy -Assessment of quadriceps muscle strength-
Scientific Title:Acronym	Postoperative recovery after anterior quadratus lumborum block for laparoscopic nephrectomy -Assessment of quadriceps muscle strength-
Region	Japan

Condition
Condition	kidney cancer
Classification by specialty	Anesthesiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	postoperative recovery after anterior quadratus lumborum block
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	manual muscle testing of quadriceps on the day before surgery, 24 and 96 hours after surgery
Key secondary outcomes	postoperative muscle strength of quadriceps(25% reduction from baseline in quadriceps is considered clinically relevant), numerical rating scale at 2,24 and 96 hours after surgery postoperative consumption of opioids and the time until the first demand of opioids Quolity of Recovery(QoR)-15 on the day before surgery and 24, 96 hours after surgery the number of uses of non-opioids a rate of incidence of postoperative nausea and vomitting

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	75 years-old >
Gender	Male and Female
Key inclusion criteria	patients who scheduled for laparoscopic or robotic-assisted partial nephrectomy 1. patients who signed the informed consent for this study after an adequate explanation 2.patients aged 20 or over but under 75
Key exclusion criteria	1. patients who refused to participate this study or who cannot seem to participate due to the postoperative conditions 2. patients who takes opioids for a long time 3. patients who have allergy to local anesthetics 4. patiens who have dermatosis at a puncture site or abdomen 5. patients who have following abnormalities in screening tests PT-INR > 1.25 APTT > 35 Platelet counts < 100000 /microlitter 6.patients who takes antithrombotic therapy, and do not have the adequate interruption period according to the Japanese guidelines, Perioperative Management of Antithromboic Therapy. 7. patients who have muscle weakness of lower extremities before surgeries 8. patients who cannot fully extend their knees due to the pain 9. patients who weigh under 40kg, or whose BMI is over 35 10. patients who we are not allowed to visit due to the prevention of coronavirus infection 11. other inappropriate patients judged by reserchers
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Yuma Middle name Last name Kadoya
Organization	Nara Medical Univerysity Hospital
Division name	Anesthesiology
Zip code	634-8522
Address	840, Shijo-cho, Kashihara-shi, Nara prefecture
TEL	0744-22-3051
Email	kadoyayuuma@naramed-u.ac.jp

Public contact
Name of contact person	1st name Yuma Middle name Last name Kadoya
Organization	Nara Medical Univerysity Hospital
Division name	Anesthesiology
Zip code	634-8522
Address	840, Shijo-cho, Kashihara-shi, Nara prefecture
TEL	0744-22-3051
Homepage URL
Email	kadoyayuuma@naramed-u.ac.jp

Sponsor
Institute	Nara Medical Univerysity Hospital
Institute
Department

Funding Source
Organization	Internal funding
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	Nara Medical University Ethics Committee
Address	840, Shijo-cho, Kashihara-shi, Nara prefecture
Tel	0744-22-3051
Email	ino_rinri@naramed-u.ac.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	奈良県立医科大学附属病院（奈良県）

Other administrative information
Date of disclosure of the study information	2020 Year 10 Month 14 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	Open public recruiting
Date of protocol fixation	2020 Year 08 Month 24 Day
Date of IRB	2020 Year 10 Month 13 Day
Anticipated trial start date	2020 Year 10 Month 14 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	This is an observational study to evaluate the postoperative weakness of quadriceps after nerve block.

Management information
Registered date	2020 Year 10 Month 14 Day
Last modified on	2021 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047596