RECRUITINGPhase 2 / Phase 3INTERVENTIONAL
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
About This Trial
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 May Be Eligible (Plain English)
Who May Qualify:
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 willing to sign a consent form and be willing to follow protocol requirements
Who Should NOT Join This Trial:
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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
BEHAVIORAL
Group 1
Participants will receive hypnosedation will be restarted after arriving in the operating room and will continue for the whole time of surgery
BEHAVIORAL
Group 2
Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room
BEHAVIORAL
Group 3
Participants will receive standard general anesthesia and medications during surgery to control your pain.
Locations (1)
M D Anderson Cancer Center
Houston, Texas, United States