Image

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

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

Recruiting
19-80 years
Female
Phase 3

Powered by AI

Overview

In 230 patients undergoing mastectomy, the investigators will compare opioid-free anesthesia (OFA) versus conventional opioid-based anesthesia in terms of chronic pain. The enrolled patients will be randomly assigned into two groups with 1:1 ratio. Chronic pain will be evaluated at 1 year after mastectomy based on the Breast Cancer Pain Questionnaire (BCPQ). Baseline pain sensitivity test and psychologic evaluation will be done before operation.

Description

Study population

  1. All of patients will undergo mastectomy with or without immediate breast reconstruction.
  2. 230 patients will be enrolled.

Intervention

  1. OFA group will be sedated using dexmedetomidine and lidocaine.
  2. Conventional opioid anesthesia group will be sedated using remifentanil.

Pain screening

  1. Breast Cancer Pain Questionnaire (BCPQ)
  2. Pain-detect, HADS, EQ-5D, PHQ-15 (somatic symptom), PCS (pain catastrophizing), BFI (big five inventory), HAM-A&D, Pressure algometry (Pain sensitivity), Quantitative sensory test (pinprick)

Eligibility

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

Study details
    Breast Cancer
    Mastectomy
    Pain
    Chronic
    Pain
    Post Operative

NCT05146778

Gangnam Severance Hospital

27 January 2024

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.