Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery

Breast Cancer Clinical Trial

Official title:

Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05766891
• Other study ID #: 2022-0959
• Secondary ID: NCI-2023-02059
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: October 12, 2023
• Est. completion date: December 31, 2028

Study information

• Verified date: November 2023
• Source: M.D. Anderson Cancer Center
• Contact: Lorenzo Cohen, MD
• Phone: (713) 745-4260
• Email: lcohen[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 225
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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, or if surgery is likely greater than 3 hours

9. Patients with hearing loss that could preclude HS facilitation

10. Known allergy to propofol or other medications used during surgery

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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
• Group 2
Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room
• Group 3
Participants will receive standard general anesthesia and medications during surgery to control your pain.

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trait/State Anxiety Questionnaire	Trait/State Anxiety Questionnaire will be assessed with the 40-item Spielberger State Trait Anxiety Inventory (STAI)53. The STATE scale is a 20-item scale that provides information about a person's current level of anxiety. The TRAIT scale is a 20-item scale that provides information about a person's general anxiety.	through study completion; an average of 1 year.

External Links

•   M D Anderson Cancer Center