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

To hypnosedation alone given before and during surgery on reducing opioid use after surgery compared to standard general anesthesia given alone or with hypnosedation.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Group 1; Behavioral: Group 2; Behavioral: Group 3

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.

• Study Type: Interventional
• Enrollment (Estimated): 225
• Phase: Phase 2; Phase 3

Contacts and Locations

• Study Contact: Name: Lorenzo Cohen, MD; Phone Number: (713) 745-4260; Email: lcohen@mdanderson.org

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • Recruiting
      • M D Anderson Cancer Center
      • Principal Investigator: Lorenzo Cohen, MD
      • Contact: Lorenzo Cohen, MD; Phone Number: 713-745-4260; Email: lcohen@mdanderson.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1; Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery	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.
Experimental: Group 2; Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.	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.
Experimental: Group 3; Participants will receive standard general anesthesia alone. You will not receive hypnosedation.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Institutes of Health (NIH)
• Investigators: Principal Investigator: Lorenzo Cohen, MD, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• M D Anderson Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2023
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: March 2, 2023
• First Submitted That Met QC Criteria: March 2, 2023
• First Posted (Actual): March 13, 2023

Study Record Updates

• Last Update Posted (Estimated): April 26, 2024
• Last Update Submitted That Met QC Criteria: April 25, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 2022-0959; NCI-2023-02059 (Other Identifier: NCI-CTRP Clinical Trials Registry)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No