Breast Cancer Clinical Trial
Official title:
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Status | Recruiting |
Enrollment | 225 |
Est. completion date | December 31, 2028 |
Est. primary completion date | December 31, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Men and Women; 2. Age 18 or older; 3. Diagnosed with stage 0/1 BCa; 4. Scheduled for a unilateral, segmental mastectomy ± SLND 5. Able to read, write and speak English or Spanish 6. Able to sign a written informed consent and be willing to follow protocol requirements. Exclusion Criteria: 1. Extreme mobility issues that preclude participating in the study 2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD; 3. Low score on Tellegen Absorption Scale (10 or below, a correlate of hypnotic suggestibility) 4. History of chronic opioid use 5. Current pain 2 or above on 0-10 scale 6. Co-mobilities such as uncontrollable diabetes or hypertension 7. Plastic surgery involvement for oncoplastic reconstruction 8. Have undergone chemotherapy, or if surgery is likely greater than 3 hours 9. Patients with hearing loss that could preclude HS facilitation 10. Known allergy to propofol or other medications used during surgery |
Country | Name | City | State |
---|---|---|---|
United States | M D Anderson Cancer Center | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
M.D. Anderson Cancer Center | National Institutes of Health (NIH) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
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