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

March 12, 2026 updated by: M.D. Anderson Cancer Center
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

Intervention / Treatment

Detailed Description

OBJECTIVES

The proposed trial will randomize women and men with stage 0/I breast cancer scheduled for a lumpectomy, including excisional biopsy, ± 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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Recruiting
        • M D Anderson Cancer Center
        • Principal Investigator:
          • Lorenzo Cohen, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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. Scheduled for a unilateral, breast surgical procedure, ± SLND
  4. Able to read, write and speak English or Spanish
  5. 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. History of chronic opioid use
  4. Current pain 2 or above on 0-10 scale
  5. Co-mobilities such as uncontrollable diabetes or hypertension
  6. Plastic surgery involvement for oncoplastic reconstruction
  7. Have undergone chemotherapy for current breast cancer diagnosis
  8. 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Experimental: Group 2
Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.
Behavioral: Group 2
Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room
Experimental: Group 3
Participants will receive standard general anesthesia alone. You will not receive hypnosedation.
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
Morphine Equivalent Daily Dose (MEDD)
Time Frame: through study completion; an average of 1 year.
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.
through study completion; an average of 1 year.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

M.D. Anderson Cancer Center

Collaborators

National Cancer Institute (NCI)
Rising Tide Foundation

Investigators

  • Principal Investigator: Lorenzo Cohen, MD, M.D. Anderson Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 12, 2023

Primary Completion (Estimated)

December 31, 2027

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 (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-0959
  • NCI-2023-02059 (Other Identifier: NCI-CTRP Clinical Trials Registry)
  • 5R01CA272565 (U.S. NIH Grant/Contract)
  • CCR-23-500 (Other Grant/Funding Number: Rising Tide Foundation for Clinical Cancer Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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