Skip to content

A study to compare different methods of local anesthesia during uterine surgery and their effects on pain

A Prospective Single-Center Two-Group Comparative Study on the Efficacy of Intraoperative Paracervical Block for Postoperative Pain Control in Vaginally Assisted NOTES Hysterectomy - PLUTO study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000061338
Enrollment
40
Registered
2026-04-21
Start date
2026-04-21
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with benign uterine diseases undergoing transvaginal natural orifice transluminal endoscopic surgery (vNOTES) hysterectomy

Interventions

PCB with lidocaine (total 10 mL) PCB with normal saline (total 10 mL) as placebo

Sponsors

Kobe City Nishi-Kobe Medical Center
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Patients scheduled to undergo VANH who have received a written explanation of the study and provided informed consent prior to surgery.

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Postoperative pain assessed using the visual analog scale (VAS) at 6 hours after surgery.

Countries

Japan

Contacts

Public ContactAi Kogiku

Kobe City Nishi-Kobe Medical Center Obstetrics and gynecology

ai_kogiku@kcho.jp0789972200

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026