Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
Recruiting · NCT05766891 · Interventional (participants receive a specific treatment) · Lead sponsor: M.D. Anderson Cancer Center
View the official record on ClinicalTrials.gov →Interventions studied
Group 1Group 2Group 3
What this trial is about
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Men and Women;
- Age 18 or older;
- Scheduled for a unilateral, breast surgical procedure, ± SLND
- Able to read, write and speak English or Spanish
- Able to sign a written informed consent and be willing to follow protocol requirements
Exclusion criteria
- Extreme mobility issues that preclude participating in the study
- Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD
- History of chronic opioid use
- Current pain 2 or above on 0-10 scale
- Co-mobilities such as uncontrollable diabetes or hypertension
- Plastic surgery involvement for oncoplastic reconstruction
- Have undergone chemotherapy for current breast cancer diagnosis
- Surgery is likely greater than 3 hours
- Patients with hearing loss that could preclude HS facilitation
- Known allergy to propofol or other medications used during surgery
Where it is running
1 location listed across 1 US state.
- M D Anderson Cancer Center - Houston, Texas, United States