Personalizing Preprocedural Sedation for Regional Anesthesia

Study Overview
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Brief Summary
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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
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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.

Official Title
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Personalizing Preprocedural Sedation for Regional Anesthesia: A Randomized Trial and Qualitative Assessment of Patient-Centered Outcomes and Experience

Conditions
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Catastrophizing Pain

Intervention / Treatment
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* Drug: Midazolam and Fentanyl
* Behavioral: Educational Reassurance


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel and crossover design. Subjects in Arm 2 may crossover to Arm 1 if they receive pharmacologic sedation.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High Pain Catastrophizing<br>Based on the Pain Catastrophizing Scale (PCS) | Drug: Midazolam and Fentanyl<br>* Prior to the start of the nerve block, patients in Arm 1 will receive titrated pharmacological sedation with IV midazolam with a goal of achieving moderate sedation. If pain is felt despite subcutaneous lidocaine, IV fentanyl may be administered with a goal of achieving moderate sedation with analgesia.<br>* Other names: Sublimaze;Behavioral: Educational Reassurance<br>* Patients in the nonpharmacologic group will receive intraprocedural education and reassurance without pharmacologic sedation. They will have the option to receive more pharmacologic sedation at any point during the nerve block (cross-over to titrated sedation group).<br>|
| Experimental: Low Pain Catastrophizing<br>Based on the Pain Catastrophizing Scale (PCS) | Drug: Midazolam and Fentanyl<br>* Prior to the start of the nerve block, patients in Arm 1 will receive titrated pharmacological sedation with IV midazolam with a goal of achieving moderate sedation. If pain is felt despite subcutaneous lidocaine, IV fentanyl may be administered with a goal of achieving moderate sedation with analgesia.<br>* Other names: Sublimaze;Behavioral: Educational Reassurance<br>* Patients in the nonpharmacologic group will receive intraprocedural education and reassurance without pharmacologic sedation. They will have the option to receive more pharmacologic sedation at any point during the nerve block (cross-over to titrated sedation group).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain scale | 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. | Immediately following procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Satisfaction with nerve block on a 1 (low satisfaction) to 10 (high satisfaction) Likert scale. Higher scores represent a better outcome. | Immediately following procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catastrophizing, Regional anesthesia, Nerve block, Preprocedural sedation