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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT05766891
Phase
PHASE2/PHASE3
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

Start date
Oct 12, 2023
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
225 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

Arms

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

Primary Outcome Measure

Morphine Equivalent Daily Dose (MEDD) [ Time Frame: through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Lorenzo Cohen, MD
[email protected]
713-745-4260
Lorenzo Cohen, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
M D Anderson Cancer Center· Houston, TX

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