Ignite Creation Date:
2024-05-06 @ 6:43 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766891
Status:
RECRUITING
Last Update Posted:
2024-04-26
First Post:
2023-03-02
Brief Title:
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
Opioid-Sparing Effects of Nurse-Delivered Hypnosis During Breast Cancer Surgery
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Detailed Description:
OBJECTIVES
The proposed trial will randomize women and men with stage 0I 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 nauseavomiting 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
The proposed trial will randomize women and men with stage 0I 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 nauseavomiting 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-2023-02059 | OTHER | NCI-CTRP Clinical Trials Registry | None |