ClinConnect ClinConnect Logo
Search / Trial NCT05146778

A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia

Launched by GANGNAM SEVERANCE HOSPITAL · Dec 2, 2021

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how to reduce long-lasting pain after a mastectomy, which is surgery to remove breast tissue, by using a type of anesthesia that does not include opioids (strong pain medications). The researchers will compare this opioid-free anesthesia to traditional anesthesia that does use opioids in 230 women who are having a mastectomy, with or without immediate breast reconstruction. They want to see which method leads to less chronic pain one year after the surgery. Before the surgery, participants will complete some tests to measure their pain sensitivity and psychological health.

To participate in this study, women aged 18 and older who are scheduled for a mastectomy may be eligible, provided they do not have certain conditions, such as a previous history of breast surgery, allergies to medications, other types of cancer, or significant psychological disorders. Participants will be randomly assigned to one of the two anesthesia groups and will be monitored for their pain levels over the following year. This research aims to find safer and more effective pain management options for patients undergoing mastectomy.

Gender

FEMALE

Eligibility 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

About Gangnam Severance Hospital

Gangnam Severance Hospital is a renowned medical institution located in Seoul, South Korea, dedicated to advancing healthcare through innovative research and clinical excellence. As a leading clinical trial sponsor, the hospital is committed to conducting cutting-edge research that enhances patient care and contributes to medical knowledge across various specialties. With a state-of-the-art facility and a multidisciplinary team of experienced researchers and healthcare professionals, Gangnam Severance Hospital prioritizes patient safety and ethical standards while striving to develop new treatments and therapies that address unmet medical needs. Through collaboration with academic institutions and industry partners, the hospital plays a pivotal role in shaping the future of medicine.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Sung Gwe G Ahn, M.D.,Ph.D.

Principal Investigator

Gangnam Severance Hospital

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Similar Trials