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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000040624
Receipt No. R000046363
Scientific Title Comparison of postoperative analgesia between ultrasound-guided rectus sheath block and laparoscopic-guided rectus sheath block in transabdominal preperitoneal approach (TAPP) for laparoscopic inguinal hernia surgery
Date of disclosure of the study information 2020/06/02
Last modified on 2020/12/02

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Basic information
Public title Study of rectus sheath block in transabdominal preperitoneal approach (TAPP) for laparoscopic inguinal hernia surgery
Acronym Study of rectus sheath block in transabdominal preperitoneal approach (TAPP) for laparoscopic inguinal hernia surgery
Scientific Title Comparison of postoperative analgesia between ultrasound-guided rectus sheath block and laparoscopic-guided rectus sheath block in transabdominal preperitoneal approach (TAPP) for laparoscopic inguinal hernia surgery
Scientific Title:Acronym Comparison of postoperative analgesia between ultrasound-guided rectus sheath block and laparoscopic-guided rectus sheath block in transabdominal preperitoneal approach (TAPP) for laparoscopic inguinal hernia surgery
Region
Japan

Condition
Condition Inguinal Hernia
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Usefulness of rectus sheath block
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Postoperative analgesia due to ultrasound-guided rectus sheath block anesthesia evaluated by Numerical Rating Scale
Key secondary outcomes Postoperative analgesia due to rectus sheath block anesthesia evaluated by Numerical Rating Scale in the laparoscopic-guided group and the ultrasound-guided group and in the laparoscopic-guided and the control group

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 3
Purpose of intervention Treatment
Type of intervention
Maneuver
Interventions/Control_1 Group C: No rectus sheath block anesthesia
Interventions/Control_2 Group U: ultrasound-guided rectus sheath block anesthesia. At the beginning of surgery, 0.375% Ropivacaine Hydrochloride Hydrate is injected into the right and left rectus sheaths, 15 mL each.
Interventions/Control_3 Group L: Laparoscopic-guided rectus sheath block anesthesia. At the beginning of surgery, 0.375% Ropivacaine Hydrochloride Hydrate is injected into the right and left rectus sheaths, 15 mL each.
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

Not applicable
Gender Male and Female
Key inclusion criteria Patients who meet the following criteria to undergo laparoscopic inguinal hernia surgery TAPP method for inguinal hernia (inguinal hernia / femoral hernia). Patients aged 20 years or older at the time of obtaining consent. Patients who are fully informed and have free written consent of the patient.
Key exclusion criteria Patients who are indicated for emergency surgery (incarceration, etc.). Patients who have difficulty in expressing pain. Patients who regularly take painkillers and corticosteroids.
Target sample size 90

Research contact person
Name of lead principal investigator
1st name Yuichiro
Middle name
Last name Miyaki
Organization Seirei Hamamatsu General Hospital
Division name Department of Surgery
Zip code 430-8558
Address 2-12-12 Sumiyoshi, Naka-ku Hamamatsu, Shizuoka JAPAN 430-8558
TEL 053-474-2222
Email y.miyaki@sis.seirei.or.jp

Public contact
Name of contact person
1st name Yuichiro
Middle name
Last name Miyaki
Organization Seirei Hamamatsu General Hospital
Division name Department of Surgery
Zip code 430-8558
Address 2-12-12 Sumiyoshi, Naka-ku Hamamatsu, Shizuoka JAPAN 430-8558
TEL 053-474-2222
Homepage URL
Email y.miyaki@sis.seirei.or.jp

Sponsor
Institute Seirei Hamamatsu General 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 Seirei Hamamatsu General Hospital, Clinical Research Review Committee
Address 2-12-12 Sumiyoshi, Naka-ku Hamamatsu, Shizuoka JAPAN 430-8558
Tel 053-474-2222
Email m-kimata@sis.seirei.or.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 聖隷浜松病院(静岡県)/ Seirei Hamamatsu General Hospital(Shizuoka Prefecture)

Other administrative information
Date of disclosure of the study information
2020 Year 06 Month 02 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 05 Month 29 Day
Date of IRB
2020 Year 05 Month 29 Day
Anticipated trial start date
2020 Year 06 Month 02 Day
Last follow-up date
2021 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
2020 Year 06 Month 02 Day
Last modified on
2020 Year 12 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046363

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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