Breast Cancer, Mastectomy, Pain, Chronic, Pain, Post Operative
Conditions
Brief 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. 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 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)
Interventions
PROCEDUREOpioid-free anesthesia
OFA group will be sedated using dexmedetomidine and lidocaine.
PROCEDUREConventional opioid-based anesthesia
Conventional opioid-based anesthesia group will be sedated using remi-fentanyl
Sponsors
Gangnam Severance Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Masking description
Patients will be not aware of which type of anesthesia would be applied during operation.
Intervention model description
1. Control arm: Conventional Anesthesia with opioid 2. Interventional arm: Opiod-free Anesthesia with dexmedetomidine and lidocaine
Eligibility
Sex/Gender
FEMALE
Age
19 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| chronic breast pain at 1 year after mastectomy | 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
| Measure | Time frame | Description |
|---|---|---|
| psychological symptoms | 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. |
| Pain Sensitivity | 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. |
Countries
South Korea
Contacts
Primary ContactSung Gwe Ahn, M.D.,Ph.D.
Backup ContactSoong June Bae, M.D.
Outcome results
None listed