Personalizing Preprocedural Sedation for Regional Anesthesia

Early Phase 1

Completed

• Conditions: Catastrophizing Pain
• Interventions: Drug: Midazolam and Fentanyl; Behavioral: Educational Reassurance

• Registration Number: NCT05579509
• Lead Sponsor: Brigham and Women's Hospital

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.

Study Timeline

• Study First Submitted: 2022-09-29
• Study First Submitted QC: 2022-10-12
• Study First Posted: 2022-10-13
• Study Start: 2022-10-22
• Primary Completion: 2024-05-24
• Study Completion: 2024-05-24
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-24
• Last Update Posted: 2025-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Pain Catastrophizing	Educational Reassurance	Based on the Pain Catastrophizing Scale (PCS)
Low Pain Catastrophizing	Midazolam and Fentanyl	Based on the Pain Catastrophizing Scale (PCS)
Low Pain Catastrophizing	Educational Reassurance	Based on the Pain Catastrophizing Scale (PCS)
High Pain Catastrophizing	Midazolam and Fentanyl	Based on the Pain Catastrophizing Scale (PCS)

Primary Outcome Measures

Name	Time	Method
Pain scale	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 Outcome Measures

Name	Time	Method
Patient satisfaction	Immediately following procedure	Satisfaction with nerve block on a 1 (low satisfaction) to 10 (high satisfaction) Likert scale. Higher scores represent a better outcome.

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States