Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
批准号:
10668632
负责人:
Lorenzo Cohen
金额:
$66.95万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-05-01 至 2028-04-30
关键词:
Absence of pain sensationAddressAffectAnalgesicsAnesthesia proceduresAnxietyBreast Cancer TreatmentBreast biopsyCellular ImmunityCertified registered nurse anesthetistClinicalDataDay SurgeryDoseEuropeFatigueFentanylGeneral AnesthesiaHypnosisIleusImmunosuppressionImpaired cognitionIndividual DifferencesInfusion proceduresInterventionIntravenous AnesthesiaLaryngeal MasksLightLocal AnestheticsLocal anesthesiaMedicalMedical Care CostsMethodsMissionNauseaNeurologicNursesOperative Surgical ProceduresOpioidPainPatient Outcomes AssessmentsPatient Self-ReportPatientsPharmaceutical PreparationsPhysiologicalPopulationPostoperative Nausea and VomitingPostoperative PeriodProceduresProcessPropofolPruritusPsychological StressPsychosocial FactorPublic HealthRandomizedRecoveryRecovery RoomReportingResearchRiskScheduleSentinel Lymph Node BiopsySerious Adverse EventSurgical complicationTechniquesTestingThinkingTimeTime and Motion StudiesUnconscious StateUnited StatesUnited States National Institutes of HealthUrinary RetentionVomitingWomanabsorptionbiopsychosocialbreast lumpectomybreast surgerycancer diagnosiscancer surgerycancer therapyclinical practicecostcost effectiveeconomic evaluationefficacy evaluationexpectationhemodynamicsimprovedimproved outcomeinstrumentationintervention effectmalignant breast neoplasmmembermenmorphine equivalentopioid epidemicopioid misuseopioid sparingopioid useoutcome predictionpain sensitivitypostoperative recoverypsychologicrandomized trialresponsesatisfactionside effectstandard carestandard of caretime usetraittreatment as usualtumorwound healing
中文摘要
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英文摘要
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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