Clinical trial NCT05579509: Personalizing Preprocedural Sedation for Regional Anesthesia
Official title: Personalizing Preprocedural Sedation for Regional Anesthesia: a Randomized Trial and Qualitative Assessment of Patient-Centered Outcomes and Experience
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Catastrophizing Pain
Keywords: Catastrophizing
Regional anesthesia
Nerve block
Preprocedural sedation
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2022-10-13
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel and crossover design. Subjects in Arm 2 may crossover to Arm 1 if they receive pharmacologic sedation.
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: Inclusion Criteria:

* Age≥18
* 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

Primary outcomes:
measure: Pain scale
timeFrame: Immediately following procedure
Secondary outcomes:
measure: Patient satisfaction
timeFrame: Immediately following procedure
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Yun-Yun K Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: