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NCT Number: NCT05146778

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

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Chronic Pain Mastectomy Neoplasms Neoplasms by Site Neurologic Manifestations Pain Pain, Chronic Pain, Post Operative Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

19 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Gangnam Severance Hospital

Seoul, 135270, South Korea

Location status: Recruiting

Location contact

Sung Gwe Ahn, MD, PhD

CONTACT

[email protected]

82-2-2019-3370

About this study

Study population

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

Intervention

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

Pain screening

  • Breast Cancer Pain Questionnaire (BCPQ)
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opioid-free anesthesia

Procedure

OFA group will be sedated using dexmedetomidine and lidocaine.

Other names: Dexmedetomidine and lidocaine-based anesthesia

Conventional opioid-based anesthesia

Procedure

Conventional opioid-based anesthesia group will be sedated using remi-fentanyl

Other names: Remi-fentanyl

Primary outcomes

  1. chronic breast pain at 1 year after mastectomy

    Time frame: 1 year after mastectomy

    chronic pain will be assessed by Breast Cancer Pain Questionnaire (BCPQ). Zero score means absence of persisting breast-related pain. The minimum and maximum values of pain scale are 0 and 11, respectively. High score means worse outcome. Moderating role of preoperative psychosocial factors on the impact of OFA on chronic postoperative pain will be evaluated.

Secondary outcomes

  1. psychological symptoms

    Time frame: 1 year after mastectomy

    Presence of anxiety and depression symptoms will be assessed by HADS (Hospital Anxiety and Depression Scale) questionnaire. The range of each symptoms scale is between 0 and 21. A scale of 0-7 is defined as normal, a scale of 8-10 is defined as borderline, and a scale of 11-21 is defined as abnormal. High score means worse outcome.

  2. Pain Sensitivity

    Time frame: 1 year after mastectomy

    The type of pain will be assessed by painDetect Questionnaire (PDQ). The PDQ comprises 12 items. The first three assess current pain, strongest pain during the past 4 weeks, and average pain during the past 4 weeks on a 0-10 point numerical rating scale from "none" to "worst imaginable".

Study contacts

Contact information is provided by the study sponsor or research team.

Soong June Bae, M.D.

CONTACT

[email protected]

82220193370

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

CONTACT

[email protected]

82220194402

Sponsors and collaborators

Lead sponsor

Gangnam Severance Hospital

Other

Registry information

Official study title

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

Acronym: RELIEF

Important dates

Study start
2021
Primary completion
2026
Study completion
2027
First posted
Dec 7, 2021
Registry last updated
Nov 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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