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Can skipping opioids during mastectomy protect the immune system?

NCT ID NCT07798895

Symptom relief Sponsor: Muhammad Fiqhi Amiruddin Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 02, 2026 · Last updated Sep 03, 2026 · Updated 1 time

Summary

This trial compares two anesthesia approaches for women having a mastectomy for breast cancer. One group receives opioid-free anesthesia with a pectoral nerve block, while the other receives standard opioid-based anesthesia with fentanyl. Researchers measure CD4+ T-cell counts before and 24 hours after surgery to see how each method affects immune response, and they track pain and nausea for the first day. The goal is to learn whether avoiding opioids can preserve immune function and improve recovery 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
Opioid-free anesthesia using dexmedetomidine and a pectoral nerve block, compared with fentanyl-based opioid anesthesia
What this could lead to
If it works, this approach could offer a way to reduce opioid use during breast cancer surgery while better preserving immune function and controlling pain.
What could go wrong
This is a small, early-stage trial with only 28 participants, so results may not apply broadly. The nerve block and drug regimen carry their own risks, and the immune benefit is not yet proven.

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

28 people

The number who actually took part.

Started

May 2026

Finished

Jul 2026

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

18 to 65 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 18-65 years. 2. Patients undergoing modified radical mastectomy for breast cancer. 3. American Society of Anesthesiologists (ASA) Physical Status I-II. 4. Body mass index (BMI) \>18 and \<30 kg/m². 5. Patients who agreed to participate and provided written informed consent. Exclusion Criteria: 1. Major cardiovascular disease. 2. Cerebrovascular disease. 3. Hepatic or renal disease. 4. Uncontrolled systemic disease. 5. Previous chemotherapy or radiotherapy. 6. Long-term opioid use. 7. Allergy to local anesthetics or opioids. 8. Infection at the injection site. 9. Coagulation disorders. 10. Bilateral breast surgery. 11. Refusal to participate in the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm Pain, Postoperative Postoperative Nausea and Vomiting

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Jl. Perintis Kemerdekaan Km. 10, Makassar 90245, Indonesia

    Makassar, South Sulawesi, 90245, Indonesia

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