Breast CancerRELIEFNCT05146778
A Study to Reduce Persistent Post-mastectomy Pain Using Opioid-free Anesthesia
A study testing Opioid-free anesthesia and Conventional opioid-based anesthesia in people with Breast Cancer and Mastectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 80 years, women only
- Conditions the study is for
- Breast Cancer, Mastectomy, Pain, Chronic
- What is being tested?
- Opioid-free anesthesia and Conventional opioid-based anesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Dec 2021to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All of patients will undergo mastectomy with or without immediate breast reconstruction.
Who cannot join
- Previous history of breast surgery
- Allergy to drug
- Other cancer history
- Underlying psychologic disorder
- Patients with chronic pain requiring pain killers
- Baseline SpO2 <95%
Show all 10Show fewer
- Left ventricular EF <40%
- Bradycardia as HR <50 bpm
- BMI >35kg/m2
- Pregnant woman
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Gangnam Severance Hospital
Seoul, 135270
Sung Gwe Ahn, MD, PhD, 82-2-2019-3370, asg2004@yuhs.ac
About this study
Official title: A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal 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.
Read the detailed description
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)
- Conditions
- Breast Cancer, Mastectomy, Pain, Chronic, Pain, Post Operative
- Being tested
- Opioid-free anesthesia, Conventional opioid-based anesthesia
- Medical subject headings
- Breast Neoplasms, Chronic Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-free anesthesiaProcedure or surgery
Also called Dexmedetomidine and lidocaine-based anesthesia
OFA group will be sedated using dexmedetomidine and lidocaine.
Conventional opioid-based anesthesiaProcedure or surgery
Also called Remi-fentanyl
Conventional opioid-based anesthesia group will be sedated using remi-fentanyl
| Study group | Role | What they receive |
|---|---|---|
| Opioid-free anesthesia group | Active comparator | OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy. Receives: Procedure: Opioid-free anesthesia |
| Conventional anesthesia group with opioid | Active comparator | Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy. Receives: Procedure: Conventional opioid-based anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
chronic breast pain at 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.
Measured: 1 year after mastectomy
Secondary outcomes (2)
psychological symptoms
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.
Measured: 1 year after mastectomy
Pain Sensitivity
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".
Measured: 1 year after mastectomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start16 Dec 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 1. Control arm: Conventional Anesthesia with opioid 2. Interventional arm: Opiod-free Anesthesia with dexmedetomidine and lidocaine
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 230 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sung Gwe Ahn, Gangnam Severance Hospital
- Investigators
- Sung Gwe G Ahn, M.D.,Ph.D., Principal investigator, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05146778
- Sponsor's protocol ID
- 2021-0568-001
- Acronym
- RELIEF
- Status last verified
- Nov 2025
- First submitted
- 23 Sep 2021
- Last updated
- 21 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia
- ClinicalTrials.gov ID
- NCT05146778
- Acronym / sponsor ID
- RELIEF / 2021-0568-001
- Conditions
- Breast Cancer, Mastectomy, Pain, Chronic, Pain, Post Operative
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 230 participants (estimated)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 16 Dec 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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)
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 1. Control arm: Conventional Anesthesia with opioid 2. Interventional arm: Opiod-free Anesthesia with dexmedetomidine and lidocaine
| Arm | Type | Receives |
|---|---|---|
| Opioid-free anesthesia group | Active comparator | Procedure: Opioid-free anesthesiaOFA group will be sedated using dexmedetomidine and lidocaine during mastectomy. |
| Conventional anesthesia group with opioid | Active comparator | Procedure: Conventional opioid-based anesthesiaConventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy. |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All of patients will undergo mastectomy with or without immediate breast reconstruction.
Key exclusion criteria (10 listed)
- Previous history of breast surgery
- Allergy to drug
- Other cancer history
- Underlying psychologic disorder
- Patients with chronic pain requiring pain killers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Opioid-free anesthesiaAlso: Dexmedetomidine and lidocaine-based anesthesiaOFA group will be sedated using dexmedetomidine and lidocaine. | Procedure or surgery | Opioid-free anesthesia group |
| Conventional opioid-based anesthesiaAlso: Remi-fentanylConventional opioid-based anesthesia group will be sedated using remi-fentanyl | Procedure or surgery | Conventional anesthesia group with opioid |
Primary outcome
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.
2 secondary outcomes
psychological symptoms
Time frame: 1 year after mastectomy
Pain Sensitivity
Time frame: 1 year after mastectomy
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sung Gwe G Ahn, M.D.,Ph.D. principal investigator
Gangnam Severance Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Opioid-free anesthesia and Conventional opioid-based anesthesia in people with Breast Cancer and Mastectomy, run by Gangnam Severance Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sung Gwe Ahn, M.D.,Ph.D. (82220194402, asg2004@yuhs.ac), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
chronic breast pain at 1 year after mastectomy (time frame: 1 year after mastectomy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025.