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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.
Study population
Intervention
Pain screening
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opioid-free anesthesia group | Active Comparator | OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy. |
|
| Conventional anesthesia group with opioid | Active Comparator | Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opioid-free anesthesia | Procedure | OFA group will be sedated using dexmedetomidine and lidocaine. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after mastectomy |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after mastectomy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sung Gwe Ahn, M.D.,Ph.D. | Contact | 82220194402 | asg2004@yuhs.ac | |
| Soong June Bae, M.D. | Contact | 82220193370 | mission815815@yuhs.ac |
| Name | Affiliation | Role |
|---|---|---|
| Sung Gwe G Ahn, M.D.,Ph.D. | Gangnam Severance Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Gangnam Severance Hospital | Recruiting | Seoul | 135270 | South Korea |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D059350 | Chronic Pain |
| D010149 | Pain, Postoperative |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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Patients will be not aware of which type of anesthesia would be applied during operation.
| Conventional opioid-based anesthesia | Procedure | Conventional opioid-based anesthesia group will be sedated using remi-fentanyl |
|
|
| 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". | 1 year after mastectomy |
| D017437 |
| Skin and Connective Tissue Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |