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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High Pain Catastrophizing | Experimental | Based on the Pain Catastrophizing Scale (PCS) |
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| Low Pain Catastrophizing | Experimental | Based on the Pain Catastrophizing Scale (PCS) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Midazolam and Fentanyl | Drug | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yun-Yun K Chen, MD | Brigham and Women's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40473409 | Derived | Chen YK, Wilson JM, Gokul SR, Collins PW, Kiik M, Vlassakov K, Schreiber KL. Education or sedation? A randomized clinical trial of impact on procedural pain and satisfaction during regional block placement, and the moderating effect of pain catastrophizing. Reg Anesth Pain Med. 2025 Jun 5:rapm-2025-106644. doi: 10.1136/rapm-2025-106644. Online ahead of print. |
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| ID | Term |
|---|---|
| D008874 | Midazolam |
| D005283 | Fentanyl |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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Parallel and crossover design. Subjects in Arm 2 may crossover to Arm 1 if they receive pharmacologic sedation.
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| Educational Reassurance | Behavioral | 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). |
|
| D006571 | Heterocyclic Compounds |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |