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Trial Title:
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
NCT ID:
NCT05766891
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Study type:
Interventional
Study phase:
Phase 2/Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
Group 1
Description:
Participants will receive hypnosedation will be restarted after arriving in the operating
room and will continue for the whole time of surgery
Arm group label:
Group 1
Arm group label:
Group 2
Arm group label:
Group 3
Intervention type:
Behavioral
Intervention name:
Group 2
Description:
Participants will receive standard general anesthesia and medications to control your
pain after arriving in the operating room
Arm group label:
Group 1
Arm group label:
Group 2
Arm group label:
Group 3
Intervention type:
Behavioral
Intervention name:
Group 3
Description:
Participants will receive standard general anesthesia and medications during surgery to
control your pain.
Arm group label:
Group 1
Arm group label:
Group 2
Arm group label:
Group 3
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 ± 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Men and Women;
2. Age 18 or older;
3. Diagnosed with stage 0/1 BCa;
4. Scheduled for a unilateral, segmental mastectomy ± SLND
5. Able to read, write and speak English or Spanish
6. Able to sign a written informed consent and be willing to follow protocol
requirements.
Exclusion Criteria:
1. Extreme mobility issues that preclude participating in the study
2. Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or
PTSD;
3. Low score on Tellegen Absorption Scale (10 or below, a correlate of hypnotic
suggestibility)
4. History of chronic opioid use
5. Current pain 2 or above on 0-10 scale
6. Co-mobilities such as uncontrollable diabetes or hypertension
7. Plastic surgery involvement for oncoplastic reconstruction
8. Have undergone chemotherapy for current breast cancer diagnosis
9. Surgery is likely greater than 3 hours
10. Patients with hearing loss that could preclude HS facilitation
11. Known allergy to propofol or other medications used during surgery
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
M D Anderson Cancer Center
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Contact:
Last name:
Lorenzo Cohen, MD
Phone:
713-745-4260
Email:
lcohen@mdanderson.org
Investigator:
Last name:
Lorenzo Cohen, MD
Email:
Principal Investigator
Start date:
October 12, 2023
Completion date:
December 31, 2028
Lead sponsor:
Agency:
M.D. Anderson Cancer Center
Agency class:
Other
Collaborator:
Agency:
National Institutes of Health (NIH)
Agency class:
NIH
Source:
M.D. Anderson Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05766891
http://www.mdanderson.org
