Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Group 1, Group 2, Group 3.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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:
* 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.
Interventions
- 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.
Primary outcome measures
- Morphine Equivalent Daily Dose (MEDD) [Time frame: through study completion; an average of 1 year.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT05766891 · 2022-0959 · NCI-2023-02059 · 5R01CA272565 · CCR-23-500