UMIN-CTR Clinical Trial

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

kidney cancer

Classification by specialty

Anesthesiology

Classification by malignancy

Malignancy

Genomic information

NO

Narrative objectives1

postoperative recovery after anterior quadratus lumborum block

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Nara Medical Univerysity Hospital

Institute

Department

Personal name

Organization

Internal funding

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

奈良県立医科大学附属病院（奈良県）

Date of disclosure of the study information

2020

Year

10

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

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 related information

This is an observational study to evaluate the postoperative weakness of quadriceps after nerve block.

Registered date

2020

Year

10

Month

14

Day

Last modified on

2021

Year

11

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047596