UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061338 |
|---|---|
| Receipt number | R000070183 |
| Scientific Title | A Prospective Single-Center Two-Group Comparative Study on the Efficacy of Intraoperative Paracervical Block for Postoperative Pain Control in Vaginally Assisted NOTES Hysterectomy |
| Date of disclosure of the study information | 2026/04/21 |
| Last modified on | 2026/04/21 16:23:41 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
A study to compare different methods of local anesthesia during uterine surgery and their effects on pain
Acronym
PLUTO study
Scientific Title
A Prospective Single-Center Two-Group Comparative Study on the Efficacy of Intraoperative Paracervical Block for Postoperative Pain Control in Vaginally Assisted NOTES Hysterectomy
Scientific Title:Acronym
PLUTO study
Region
| Japan |
Condition
Condition
Patients with benign uterine diseases undergoing transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy
Classification by specialty
| Obstetrics and Gynecology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to evaluate whether the use of a paracervical block (PCB) in vaginally assisted natural orifice transluminal endoscopic surgery hysterectomy (VANH) reduces postoperative pain and the consumption of analgesics.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Postoperative pain assessed using the visual analog scale (VAS) at 6 hours after surgery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
PCB with lidocaine (total 10 mL)
Interventions/Control_2
PCB with normal saline (total 10 mL) as placebo
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
| 74 | years-old | >= |
Gender
Female
Key inclusion criteria
Patients scheduled to undergo VANH who have received a written explanation of the study and provided informed consent prior to surgery.
Key exclusion criteria
Patients who did not provide informed consent
Patients with a history of hypersensitivity to local anesthetics
Patients with contraindications to general anesthesia (ASA-PS >= 3)
Patients with moderate to severe renal dysfunction (eGFR <= 50 mL/min/1.73 m2)
Patients with severe hepatic dysfunction (Child-Pugh class B or C)
Patients with chronic opioid use prior to surgery
Patients with psychiatric or cognitive conditions that may interfere with reliable VAS assessment
Patients deemed unsuitable for participation by the principal investigator
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ai |
| Middle name | |
| Last name | Kogiku |
Organization
Kobe City Nishi-Kobe Medical Center
Division name
Obstetrics and gynecology
Zip code
6512273
Address
5-7-1 Kojidai, Nishi-ku, Kobe, Hyogo, Japan
TEL
0789972200
ai_kogiku@kcho.jp
Public contact
Name of contact person
| 1st name | Ai |
| Middle name | |
| Last name | Kogiku |
Organization
Kobe City Nishi-Kobe Medical Center
Division name
Obstetrics and gynecology
Zip code
6512273
Address
5-7-1 Kojidai, Nishi-ku, Kobe, Hyogo, Japan
TEL
0789972200
Homepage URL
ai_kogiku@kcho.jp
Sponsor or person
Institute
Kobe City Nishi-Kobe Medical Center
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
Kobe City Nishi-Kobe Medical Center
Address
5-7-1 Kojidai, Nishi-ku, Kobe, Hyogo, Japan
Tel
0789972200
ai_kogiku@kcho.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 | 04 | Month | 21 | 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
| 2026 | Year | 04 | Month | 21 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 26 | Day |
Anticipated trial start date
| 2026 | Year | 04 | Month | 21 | Day |
Last follow-up date
| 2027 | Year | 05 | 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
| 2026 | Year | 04 | Month | 21 | Day |
Last modified on
| 2026 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070183
