Personalizing Preprocedural Sedation for Regional Anesthesia: a Randomized Trial and Qualitative Assessment of Patient-Centered Outcomes and Experience
Overview
- Phase
- Early Phase 1
- Intervention
- Midazolam and Fentanyl
- Conditions
- Catastrophizing Pain
- Sponsor
- Brigham and Women's Hospital
- Enrollment
- 82
- Locations
- 1
- Primary Endpoint
- Pain scale
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This is a prospective, randomized study in patients who receive a nerve block prior to surgery. The aim is to investigate whether individual differences in psychosocial and pain profiles may play a role in how patients experience sedation for regional anesthesia. The study will utilize a mixed-methods approach, including a randomized controlled intervention and semi-structured interviews, in order to systematically investigate the relationship between an individual patient's level of catastrophizing and efficacy of procedural sedation, while exploring patient satisfaction with the preoperative nerve block experience.
Detailed Description
The primary quantitative outcome will be pain severity during nerve block placement. Secondary quantitative outcome is patient satisfaction. Validated psychometric assessment tools (pain catastrophizing scale) will be used to stratify patients according to baseline degree of pain catastrophizing (high versus low baseline pain catastrophizing). These groups will then be randomized to receive either titrated pharmacologic sedation (i.e., additional midazolam and fentanyl beyond a standard low midazolam dose) or intraprocedural educational reassurance. Semi-structured interviews and qualitative analysis will be used to explore patient's experiences with nerve block placement and identify themes regarding what makes this experience more positive or negative for individuals with different characteristics.
Investigators
Yun-Yun K. Chen
Principal Investigator
Brigham and Women's Hospital
Eligibility Criteria
Inclusion Criteria
- •English speaking
- •Willingness to undergo psychophysical testing
- •Willingness to have nerve block performed
- •Surgical or procedural patient
- •Single shot nerve block
Exclusion Criteria
- •Cognitive dysfunction that precludes communication
- •Declines or is not eligible clinically to receive sedation with midazolam and/or fentanyl at discretion of the non-study clinical team (Examples: frailty, cognitive dysfunction)
- •Allergy or hypersensitivity to midazolam or fentanyl
- •Declines nerve block
- •Does not complete survey needed for randomization
- •Current pregnancy and/or breastfeeding
Arms & Interventions
High Pain Catastrophizing
Based on the Pain Catastrophizing Scale (PCS)
Intervention: Midazolam and Fentanyl
High Pain Catastrophizing
Based on the Pain Catastrophizing Scale (PCS)
Intervention: Educational Reassurance
Low Pain Catastrophizing
Based on the Pain Catastrophizing Scale (PCS)
Intervention: Midazolam and Fentanyl
Low Pain Catastrophizing
Based on the Pain Catastrophizing Scale (PCS)
Intervention: Educational Reassurance
Outcomes
Primary Outcomes
Pain scale
Time Frame: Immediately following procedure
Procedural pain rating during the nerve block procedure on a 0 (no pain) to 10 (severe pain) Likert scale. Higher scores represent a worse outcome.
Secondary Outcomes
- Patient satisfaction(Immediately following procedure)