Overview
Personalizing Preprocedural Sedation for Regional Anesthesia
Status:
Not yet recruiting
Not yet recruiting
Trial end date:
2023-12-01
2023-12-01
Target enrollment:
0
0
Participant gender:
All
All
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.Phase:
N/AAccepts Healthy Volunteers?
Accepts Healthy VolunteersDetails
Lead Sponsor:
Brigham and Women's HospitalTreatments:
Fentanyl
Midazolam
Criteria
Inclusion Criteria:- Ageā„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