A Single-blinded Randomized-controlled Study to Reduce Persistent Post-mastectomy Pain Using Multimodal Opioid-free Anesthesia
Who is this study for? Patients with Post-operative Pain, Breast Cancer
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Maximum Age: 80
Healthy Volunteers: f
View:
• All of patients will undergo mastectomy with or without immediate breast reconstruction.
Locations
Other Locations
Republic of Korea
Gangnam Severance Hospital
RECRUITING
Seoul
Contact Information
Primary
Sung Gwe Ahn, M.D.,Ph.D.
asg2004@yuhs.ac
82220194402
Backup
Soong June Bae, M.D.
mission815815@yuhs.ac
82220193370
Time Frame
Start Date: 2021-12-16
Estimated Completion Date: 2027-10-31
Participants
Target number of participants: 230
Treatments
Active_comparator: Opioid-free anesthesia group
OFA group will be sedated using dexmedetomidine and lidocaine during mastectomy.
Active_comparator: Conventional anesthesia group with opioid
Conventional opioid anesthesia group will be sedated using remi-fentanyl during mastectomy.
Related Therapeutic Areas
Sponsors
Leads: Gangnam Severance Hospital