Clinical trial Recruiting at 1 site Interventional Ages 19 to 80 Women only

Reducing post-mastectomy pain with opioid-free anesthesia

Official title: A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia

Run by Gangnam Severance Hospital · NCT05146778 · Data updated 2026-11-12

This study is testing whether using anesthesia without opioids can help women who have had a mastectomy experience less chronic pain a year after their surgery compared to traditional opioid-based anesthesia.

Quick facts

Study typeInterventional
Ages19 Years to 80 Years
SexWomen only
Enrollment230 (estimated)
SponsorGangnam Severance Hospital
Academic / other
Locations1 site (Seoul)
StatusRecruiting
StartedDecember 16, 2021
Main results expectedJuly 31, 2026
Study endsOctober 31, 2027
Registry record updatedNovember 21, 2025
Trial IDNCT05146778 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are patients scheduled for mastectomy with or without immediate breast reconstruction.

Probably not a fit

Patients with a history of breast surgery, chronic pain requiring painkillers, or underlying psychological disorders may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study involves 230 patients undergoing mastectomy, where participants will be randomly assigned to receive either opioid-free anesthesia or conventional opioid-based anesthesia. The aim is to compare the effectiveness of these two approaches in reducing chronic pain one year after surgery. Pain assessments will be conducted using various questionnaires and tests to evaluate pain sensitivity and psychological factors before and after the procedure.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of chronic pain following mastectomy without the use of opioids.

How similar studies have gone: Other studies have shown promising results with opioid-free anesthesia in various surgical settings, indicating potential for success in this novel application.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* All of patients will undergo mastectomy with or without immediate breast reconstruction.

Exclusion Criteria:

* Previous history of breast surgery
* Allergy to drug
* Other cancer history
* Underlying psychologic disorder
* Patients with chronic pain requiring pain killers
* Baseline SpO2 \<95%
* Left ventricular EF \<40%
* Bradycardia as HR \<50 bpm
* BMI \>35kg/m2
* Pregnant woman

Where it's running

  • Gangnam Severance Hospital
    Seoul, South Korea
    Recruiting

Study contacts

  • Principal investigator: Sung Gwe G Ahn, M.D.,Ph.D. — Gangnam Severance Hospital
  • Study coordinator: Sung Gwe Ahn, M.D.,Ph.D.
  • Email: asg2004@yuhs.ac
  • Phone: 82220194402

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Combined PECS II and PIP blocks vs TPVB for post-mastectomy pain relief

    This trial tests whether a combination of PECS II and superficial PIP blocks can provide better or similar pain relief after mastectomy compared with the standard thoracic paravertebral block.

    Recruiting Dharmais National Cancer Center Hospital · Jakarta, DKI Jakarta · NCT07738770

  • Same-day awake mastectomy with immediate prepectoral implant reconstruction

    This project tests whether the AMADeuS care pathway—awake same-day mastectomy with prepectoral implant reconstruction, opioid-sparing anesthesia, and telemedicine follow-up—controls pain and is as safe as usual hospital care for women having mastectomy.

    Recruiting University of Rome Tor Vergata · Rome, Rome · NCT07510698

  • Using indocyanine green to find sentinel lymph nodes during mastectomy

    This pilot will test whether injecting indocyanine green and using fluorescence during mastectomy can find sentinel lymph nodes in women with clinically node-negative invasive breast cancer.

    Recruiting at 2 sites St. Antonius Hospital · Zwolle, Overijssel and 1 other locations · NCT07362485

  • AI-supported education for patients undergoing mastectomy

    This study is testing whether an AI-supported education program can help reduce fear and anxiety in women getting a mastectomy for breast cancer compared to standard education.

    Recruiting Bezmialem Vakif University · Istanbul, Bakirköy · NCT06796166

  • Comparing two nerve-block options to reduce pain after total mastectomy.

    This test tries whether a PECS-II block given before surgery or a pectoral block given during surgery, using bupivacaine or liposomal bupivacaine, provides better pain control after total mastectomy for breast cancer or high-risk patients.

    Recruiting Phase 4 University of Cincinnati · Cincinnati, Ohio · NCT06574022

  • Opioid-free anesthesia for breast cancer surgery

    This study tests whether using opioid-free anesthesia during breast cancer surgery can help patients recover better and have fewer side effects compared to traditional anesthesia.

    Recruiting University of Ioannina · Ioannina, Epirus · NCT06404983

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.