Monday, December 30, 2024
12/30/2024
PROJECT SUMMARY/ABSTRACT Breast cancer accounts for one in four cancer diagnoses in women, affecting up to one in eight women in the United States. All patients with breast cancer undergo surgery, yet surgery is not without risks and is associated with a multitude of side effects. Many of the complications from surgery are from the use of general anesthesia and intra- and postoperative opioids. Side effects of general anesthesia include hemodynamic instability, postoperative nausea and vomiting, suppression of cell-mediated immunity, cognitive impairment, and delayed recovery. The use of opioids is also associated with postoperative nausea and vomiting, ileus, urinary retention, pruritus, and immunosuppression. Frequently, intra- and postoperative opioid use often leads to an increased risk for non-medical opioid use and opioid-sparing techniques are needed. Extensive data supports the use of non-pharmacological interventions including hypnosedation (HS) for patients undergoing invasive medical procedures. In a variety of medical populations, patients using HS report significantly less anxiety and pain, demonstrate beneficial physiological responses, request less analgesic medication, and spend less time in the procedure room than controls. In a number of studies, the improved patient-reported outcomes and overall satisfaction was also paralleled by decreased medical costs. All of these previous studies either delivered the HS during simple medical procedures (e.g., breast biopsy) or before more invasive procedures such as breast surgery and no RCTs have provided hypnosis during surgery delivered by one of the surgical team members. The proposed trial will randomize women and men with breast cancer scheduled for a lumpectomy ± 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; propofol infusion, fentanyl, and local anesthetic); or 3) Usual care general anesthesia (GA). The study will examine differences in opioid use, pain, anxiety, nausea, fatigue, and cognitive dysfunction before and after surgery. Recovery will be also tracked 14 and 90 days after surgery. The study will also examine group differences in medical costs associated with procedure time, recovery room time, and use of medications. This project will allow further exploration of HS during surgery provided by a clinical team member and to explore the biopsychosocial processes associated with analgesia and opioid use, anesthesia, and pain and examine baseline individual difference factors associated with the intervention effects and recovery. We specifically propose to test the hypothesis that HS during breast cancer surgery will result in better analgesia control along with lower opioid use, less pain and psychological stress, and faster recovery than GA. Data from the proposed study will help to move this intervention into the standard of care and expand the use of HS into other invasive medical procedures where general anesthesia may be avoided.
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