UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063239 |
|---|---|
| Receipt number | R000072384 |
| Scientific Title | Postoperative pain reduction with Epinephrine And Ropivacaine paracervical bLock in vNOTES hysterectomy: the PEARL randomized controlled trial |
| Date of disclosure of the study information | 2026/10/10 |
| Last modified on | 2026/10/10 21:55:10 |
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Basic information
Public title
Postoperative pain reduction with Epinephrine And Ropivacaine paracervical bLock in vNOTES hysterectomy: the PEARL randomized controlled trial
Acronym
PEARL trial
Scientific Title
Postoperative pain reduction with Epinephrine And Ropivacaine paracervical bLock in vNOTES hysterectomy: the PEARL randomized controlled trial
Scientific Title:Acronym
PEARL trial
Region
| Japan |
Condition
Condition
Patients undergoing elective vNOTES hysterectomy for benign gynecological conditions
Classification by specialty
| Obstetrics and Gynecology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether paracervical block with ropivacaine plus epinephrine before the vaginal phase of vNOTES hysterectomy reduces early postoperative pain compared with paracervical injection of epinephrine alone.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Resting postoperative pain intensity assessed using the 11-point Numerical Rating Scale (NRS) at 2 hours after return to the ward.
Key secondary outcomes
Resting NRS at return to the ward and at 30 minutes, 1 hour, and 4 hours thereafter; area under the NRS-time curve during the first 4 hours; use, time to first administration, and amount of rescue analgesics; total rescue analgesic consumption within 24 hours; proportion of patients with NRS of 4 or higher; and adverse events and serious adverse events.
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Ropivacaine-epinephrine group (RE group): Before the vaginal phase of vNOTES hysterectomy, bilateral paracervical block is performed with 20 mL of solution containing 0.75% ropivacaine 10 mL (75 mg), epinephrine 100 micrograms and normal saline (final concentrations: ropivacaine 0.375%, epinephrine 1:200,000). Four mL is injected at each of five sites at the cervicovaginal junction (3 and 9 o'clock, bilateral uterosacral ligament bases, and 12 o'clock) after aspiration.
Interventions/Control_2
Epinephrine-alone group (E group): Using the same timing, sites, depth and volume per site, 20 mL of epinephrine 100 micrograms diluted with normal saline (1:200,000) is injected paracervically, as routinely performed for hemostasis at our institution.
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
Female
Key inclusion criteria
1. Women aged 18 years or older at the time of consent<br>2. Patients scheduled for vNOTES hysterectomy for benign gynecologic disease<br>3. Patients undergoing surgery under general anesthesia<br>4. Patients able to rate pain on the NRS<br>5. Patients who provide written informed consent of their own free will after receiving a full explanation of the study
Key exclusion criteria
1. History of hypersensitivity to ropivacaine or amide-type local anesthetics<br>2. Patients for whom epinephrine is judged inappropriate<br>3. Severe cardiovascular disease or severe hepatic or renal dysfunction<br>4. Chronic opioid use<br>5. Preoperative analgesic use or other conditions judged likely to substantially affect the primary outcome<br>6. Pregnancy or possible pregnancy<br>7. Surgery for malignant disease<br>8. Any other patient judged ineligible by the principal investigator
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Megumi |
| Middle name | |
| Last name | Sasaki |
Organization
Sendai City Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
982-8502
Address
1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi, Japan
TEL
022-308-7111
sasaki.meg@gmail.com
Public contact
Name of contact person
| 1st name | Megumi |
| Middle name | |
| Last name | Sasaki |
Organization
Sendai City Hospital
Division name
Department of Obstetrics and Gynecology
Zip code
982-8502
Address
1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi, Japan
TEL
022-308-7111
Homepage URL
sasaki.meg@gmail.com
Sponsor or person
Institute
Sendai City Hospital
Institute
Department
Personal name
Funding Source
Organization
Self funding (Sendai City Hospital)
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
Ethics Committee of Sendai City Hospital
Address
1-1-1 Asutonagamachi, Taihaku-ku, Sendai, Miyagi, Japan
Tel
022-308-7111
hpsoumu@city.sendai.jp
Secondary IDs
Secondary IDs
YES
Study ID_1
20260201
Org. issuing International ID_1
Ethics Committee of Sendai City Hospital
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
仙台市立病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 10 | Month | 10 | 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
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 25 | Day |
Date of IRB
| 2026 | Year | 10 | Month | 06 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 13 | Day |
Last follow-up date
| 2027 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2027 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2027 | Year | 12 | Month | 28 | Day |
Date analysis concluded
| 2028 | Year | 03 | Month | 31 | Day |
Other
Other related information
Analyses will follow the intention-to-treat principle, with a per-protocol sensitivity analysis for major protocol deviations such as failure to complete vNOTES. A blinded interim analysis estimating only the pooled standard deviation of the primary outcome will be performed when 40 patients have been evaluated, and the target sample size may be re-estimated up to 120. No early stopping for efficacy or futility is planned. No scheduled postoperative analgesics are given; both groups follow the same rescue analgesic protocol (acetaminophen, then flurbiprofen axetil, then diclofenac suppository). Results will be published regardless of outcome.
Management information
Registered date
| 2026 | Year | 10 | Month | 10 | Day |
Last modified on
| 2026 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072384
