Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
Trial Snapshot
- Phase
- Phase 2
- Status
- Recruiting
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 225
- Locations
- 1
- Primary Endpoint
- Morphine Equivalent Daily Dose (MEDD)
Study Overview
Brief 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.
Detailed Description
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 that HS during breast cancer surgery leads to reduced analgesia and opioid use, less pain and psychological stress, and faster recovery, as well as being more cost effective than GA or HS before surgery with GA.
Primary Objective:
To determine the efficacy of HS provided by a nurse anesthetist before and during surgery versus HS-GA or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.
Secondary Objectives:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Group 1
Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery
Intervention: Group 1 (Behavioral)
Group 2
Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.
Intervention: Group 2 (Behavioral)
Group 3
Participants will receive standard general anesthesia alone. You will not receive hypnosedation.
Intervention: Group 3 (Behavioral)
Outcomes
Primary Outcomes
Morphine Equivalent Daily Dose (MEDD)
Time Frame: through study completion; an average of 1 year.
To determine the efficacy of HS provided by a nurse anesthetist before and during surgery versus HS-GA or GA on reducing morphine equivalent daily dose (MEDD) from day of surgery through post-operative day (POD) 14.
Secondary Outcomes
No secondary outcomes reported