UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059556 |
|---|---|
| Receipt number | R000068122 |
| Scientific Title | The Effect of Laparoscopic or Ultrasound-Guided Rectus Sheath Block on Pain Relief After Inguinal Hernia Repair: A Double-Blind Randomized Controlled Trial |
| Date of disclosure of the study information | 2026/03/31 |
| Last modified on | 2026/02/12 11:02:30 |
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Basic information
Public title
The Effect of Laparoscopic or Ultrasound-Guided Rectus Sheath Block on Pain Relief After Inguinal Hernia Repair: A Double-Blind Randomized Controlled Trial
Acronym
The effect of laparoscopic rectus sheath block or ultrasound-guided rectus sheath block on pain relief
Scientific Title
The Effect of Laparoscopic or Ultrasound-Guided Rectus Sheath Block on Pain Relief After Inguinal Hernia Repair: A Double-Blind Randomized Controlled Trial
Scientific Title:Acronym
The Effect of Laparoscopic or Ultrasound-Guided Rectus Sheath Block on Pain Relief After Inguinal Hernia Repair: A Double-Blind Randomized Controlled Trial
Region
| Japan |
Condition
Condition
Inguinal Hernia Repair
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate the anesthetic effect of rectus sheath block performed under laparoscopic guidance versus that performed under ultrasound guidance on postoperative pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pain assessment at 3 hours postoperatively (NRS, Face Scale)
Key secondary outcomes
Time to awakening
Time of surgery start
Duration of the block procedure (from block timeout to completion of the block)
Pain assessment at the time of return to the ward (NRS, Face Scale)
Pain assessment at 24 hours postoperatively (NRS, Face Scale)
Postoperative analgesic use (scheduled and additional doses)
Presence or absence of postoperative complications
Patient satisfaction and complication check at 30 days postoperatively
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
Laparoscopic-Guided Rectus Sheath Block
Interventions/Control_2
Ultrasound-Guided Rectus Sheath Block
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients aged 18 years or older undergoing laparoscopic inguinal hernia repair under general anesthesia
Patients who have provided written informed consent to participate in this study
Key exclusion criteria
Patients undergoing bilateral inguinal hernia repair
Patients requiring emergency surgery (e.g., incarcerated hernia)
Patients deemed unable to undergo induction of anesthesia with intravenous anesthetics (propofol or midazolam)
Patients with known allergies to any drugs used in this study
Patients with cognitive impairment or other conditions that make it difficult to understand the questionnaire
Patients currently using analgesics
Patients suspected of drug dependence
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | shingo |
| Middle name | |
| Last name | kawashima |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Anesthesiology
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu Shizuoka
TEL
+81-53-436-1251
shingogo@hama-med.ac.jp
Public contact
Name of contact person
| 1st name | shingo |
| Middle name | |
| Last name | kawashima |
Organization
Seirei Mikatahara General Hospital
Division name
Department of Anesthesiology
Zip code
433-8558
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu Shizuoka
TEL
0534361251
Homepage URL
shingogo@hama-med.ac.jp
Sponsor or person
Institute
Seirei Mikatahara General Hospital
Institute
Department
Personal name
Funding Source
Organization
non
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 Mikatahara General Hospital
Address
3453 Mikatahara-cho, Chuo-ku, Hamamatsu
Tel
+81-53-436-1251
shingogo@hama-med.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
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 31 | 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
Enrolling by invitation
Date of protocol fixation
| 2025 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2025 | Year | 10 | Month | 20 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2029 | 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
| 2025 | Year | 10 | Month | 27 | Day |
Last modified on
| 2026 | Year | 02 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068122
