Personalizing Preprocedural Sedation for Regional Anesthesia

Mass General Brigham

Status and phase: Completed; Early Phase 1

Conditions: Catastrophizing Pain

Treatments: Drug: Midazolam and Fentanyl; Behavioral: Educational Reassurance

Study type: Interventional

Funder types: Other

Identifiers

NCT05579509

2022P001901

Details and patient eligibility

About

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.

Full 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.

Enrollment: 82 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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82 participants in 2 patient groups

High Pain Catastrophizing

Experimental group

Description:

Based on the Pain Catastrophizing Scale (PCS)

Treatment:

Behavioral: Educational Reassurance

Drug: Midazolam and Fentanyl

Low Pain Catastrophizing

Experimental group

Description:

Based on the Pain Catastrophizing Scale (PCS)

Treatment:

Behavioral: Educational Reassurance

Drug: Midazolam and Fentanyl