RecruitingPhase 2Phase 3NCT05766891
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
Sponsor
M.D. Anderson Cancer Center
Enrollment
225 participants
Start Date
Oct 12, 2023
Study Type
INTERVENTIONAL
Conditions
Summary
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Eligibility
Min Age: 18 Years
Inclusion Criteria5
- 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 Criteria10
- 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
Interventions
BEHAVIORALGroup 1
Participants will receive hypnosedation will be restarted after arriving in the operating room and will continue for the whole time of surgery
BEHAVIORALGroup 2
Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room
BEHAVIORALGroup 3
Participants will receive standard general anesthesia and medications during surgery to control your pain.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT05766891
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