M.D. Anderson Cancer Center
To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.
Breast Cancer
Group 1
Group 2
Group 3
PHASE2
PHASE3
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: * To determine the efficacy of HS with local anesthesia vs HS-GA or GA on reducing self-reported and objective pain, anxiety, nausea/vomiting, fatigue, and cognitive dysfunction. * To evaluate group differences in costs. Using time and motion studies and methods of economic evaluation, we will test the hypothesis that HS before and during surgery will lead to less time spent in the OR and PACU, lower medication use, and less need for clinical staff engagement, leading to lower overall day of surgery-related costs. * To explore psychosocial factors as moderators of the effects of the intervention and predictors of recovery. Baseline psychosocial factors including absorption, state and trait anxiety, intrusive thoughts, and discomfort intolerance, pain sensitivity, and expectations will moderate the effects of HS and predict outcomes over time.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 225 participants |
| Masking : | NONE |
| Primary Purpose : | SUPPORTIVE_CARE |
| Official Title : | Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery |
| Actual Study Start Date : | 2023-10-12 |
| Estimated Primary Completion Date : | 2027-12-31 |
| Estimated Study Completion Date : | 2028-12-31 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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RECRUITING
M D Anderson Cancer Center
Houston, Texas, United States, 77030