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

NCT05766891 | Recruiting Phase 2

• 4 other identifiers: 2022-0959NCI-2023-020595R01CA272565CCR-23-500
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Morphine Equivalent Daily Dose (MEDD)

  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.

Study Arms (3)

Group 1

EXPERIMENTAL

Participants will receive hypnosedation before and during surgery as well as local anesthesia and pain/nausea medications during surgery

Behavioral: Group 1

Group 2

EXPERIMENTAL

Participants will receive hypnosedation before surgery and standard general anesthesia during surgery.

Behavioral: Group 2

Group 3

EXPERIMENTAL

Participants will receive standard general anesthesia alone. You will not receive hypnosedation.

Behavioral: Group 3

Interventions

Group 2 BEHAVIORAL

Participants will receive standard general anesthesia and medications to control your pain after arriving in the operating room

Group 2

Group 3 BEHAVIORAL

Participants will receive standard general anesthesia and medications during surgery to control your pain.

Group 3

Group 1 BEHAVIORAL

Participants will receive hypnosedation will be restarted after arriving in the operating room and will continue for the whole time of surgery

Group 1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and Women;
• Age 18 or older;
• Scheduled for a unilateral, breast surgical procedure, ± SLND
• Able to read, write and speak English or Spanish
• Able to sign a written informed consent and be willing to follow protocol requirements

You may not qualify if:

• Extreme mobility issues that preclude participating in the study
• Major thought disorders such as schizophrenia or uncontrolled bipolar disorder or PTSD
• History of chronic opioid use
• Current pain 2 or above on 0-10 scale
• Co-mobilities such as uncontrollable diabetes or hypertension
• Plastic surgery involvement for oncoplastic reconstruction
• Have undergone chemotherapy for current breast cancer diagnosis
• Surgery is likely greater than 3 hours
• Patients with hearing loss that could preclude HS facilitation
• Known allergy to propofol or other medications used during surgery

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator
• Rising Tide Foundation: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Lorenzo Cohen, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lorenzo Cohen, MD

CONTACT

(713) 745-4260; lcohen@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 2, 2023
• First Posted: March 13, 2023
• Study Start: October 12, 2023
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

US (1)