UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040624 |
|---|---|
| Receipt number | 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 | 2023/06/05 19:49:36 |
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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
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
y.miyaki@sis.seirei.or.jp
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
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
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
90
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Under proofreading
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 | 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
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2020 | Year | 06 | Month | 02 | Day |
Last modified on
| 2023 | Year | 06 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046363
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