Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
Sponsored by M.D. Anderson Cancer Center
About this study
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
OBJECTIVES The proposed trial will randomize women and men with stage 0/I breast cancer scheduled for a lumpectomy, including excisional biopsy, ± sentinel node biopsy to one of three groups: 1) surgery with a local anesthetic, fentanyl, and HS before and during surgery (HS); 2) HS before surgery with usual care general anesthesia (HS-GA; total intravenous anesthesia rendering the patient unconscious with propofol infusion, airway instrumentation with a laryngeal mask airway or endotracheal tube, fentanyl, and local anesthetic); or 3) Usual care general anesthesia same as HS-GA group (GA). This project will allow further exploration of HS during surgery and to explore the biopsychosocial processes associated with analgesia and opioid use, anesthesia, and pain. We will test the hypotheses …
Where this study is enrolling
- I'm interested
M D Anderson Cancer Center
Houston, Texas
Who can participate
Inclusion criteria
- ✓1. Men and Women;
- ✓2. Age 18 or older;
- ✓3. Scheduled for a unilateral, breast surgical procedure, ± SLND
- ✓4. Able to read, write and speak English or Spanish
- ✓5. 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. History of chronic opioid use
- ✕4. Current pain 2 or above on 0-10 scale
- ✕5. Co-mobilities such as uncontrollable diabetes or hypertension
- ✕6. Plastic surgery involvement for oncoplastic reconstruction
- ✕7. Have undergone chemotherapy for current breast cancer diagnosis
- ✕8. 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
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Trial data sourced from ClinicalTrials.gov.