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Can a safer nerve block match the gold standard for Post-Mastectomy pain?

NCT ID NCT07738770

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial tests whether a combination of two ultrasound-guided nerve blocks (PECS II and superficial PIP) can provide pain relief and recovery quality comparable to the standard thoracic paravertebral block after mastectomy. The standard block is effective but carries a risk of lung puncture. The study will enroll women aged 18-60 undergoing mastectomy, randomly assigning them to receive either the combined block or the standard block. Pain scores, opioid use, time to first pain medication request, and recovery quality will be tracked for 24 hours after surgery.

What this could mean

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

Active substance
Combined PECS II and superficial PIP nerve block versus thoracic paravertebral block, using bupivacaine
What this could lead to
If the combined nerve block works as well as or better than the standard one, it could offer a safer option for managing pain after mastectomy, potentially reducing complications and improving recovery.
What could go wrong
This is a small, early-stage trial, so results may not apply to all patients. The combined block might not provide adequate pain relief, and there is a risk of block-related complications or side effects from the local anesthetic.

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 72 people

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

Started

Jun 2026

Expected to finish

Dec 2026

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 to 60 years

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: 1. Female patients aged 18 to 60 years. 2. Scheduled for breast cancer surgery (mastectomy with or without axillary lymph node dissection \[ALND\]). 3. American Society of Anesthesiologists (ASA) physical status I to III. 4. Provided signed written informed consent to participate in the study. Exclusion Criteria: 1. Patient refusal to participate in the study. 2. Known allergy to local anesthetics or study medications (e.g., bupivacaine, ketorolac, morphine). 3. Coagulation disorders or coagulopathy. 4. Mastectomy procedure with immediate breast reconstruction. 5. Pre-existing chronic cancer pain with active usage of strong opioids (e.g., morphine, fentanyl). 6. Cognitive impairment or inability to comprehend the pain assessment scale (NRS). 7. Pregnancy. 8. Active infection at the planned regional block injection site.

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Conditions

The condition(s) this trial relates to.

Acute Pain breast cancer breast neoplasm Pain, Postoperative

As listed by the trial registrant

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

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

  • Dharmais National Cancer Center Hospital

    RECRUITING

    Jakarta, DKI Jakarta, 11420, Indonesia

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