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Can a simple injection ease pain after keyhole pelvic surgery?

NCT ID NCT07440576

Symptom relief Sponsor: Erkan Gol Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether injecting a numbing medicine (bupivacaine) into the cervix area during vNOTES surgery can reduce pain afterward. 58 women with pelvic organ prolapse will receive either the numbing drug or a placebo (salt water). The main goal is to see if pain scores are lower 6 hours after surgery. If successful, this could mean less pain and less need for strong painkillers after the procedure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
bupivacaine
What this could lead to
If it works, this could provide a simple way to reduce pain after vNOTES surgery, leading to faster recovery and less need for painkillers.
What could go wrong
This is a small, early-stage trial with only 58 participants. The pain relief may be minimal or no better than placebo, and results may not apply to all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 58 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Female patients aged 18 years or older * Symptomatic pelvic organ prolapse requiring uterosacral ligament suspension (USLS) * Planned hysterectomy (vaginal hysterectomy or vNOTES hysterectomy) with concomitant BS or BSO, followed by vNOTES uterosacral ligament suspension * ASA physical status I-III * Ability to provide written informed consent Exclusion Criteria: * Known allergy or hypersensitivity to bupivacaine or local anesthetic agents * Chronic opioid use or chronic pain disorders * Previous pelvic radiation therapy * Severe hepatic or renal impairment * Coagulopathy or anticoagulant therapy contraindicating injection * Active pelvic infection * Pregnancy * Inability to understand the pain scoring system

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Conditions

The condition(s) this trial relates to.

Pain, Postoperative pelvic organ prolapse

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Pelvic organ prolapse (POP) Postoperative pain

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Bakirkoy Dr. Sadi Konuk Training and Research Hospital

    RECRUITING

    Istanbul, Istanbul, 34147, Turkey (Türkiye)

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