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NCT Number: NCT05579509

Personalizing Preprocedural Sedation for Regional Anesthesia

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.

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Key information

Conditions

Catastrophizing Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Versed, Sublimaze

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).

Primary outcomes

  1. Pain scale

    Time frame: 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 outcomes

  1. Patient satisfaction

    Time frame: Immediately following procedure

    Satisfaction with nerve block on a 1 (low satisfaction) to 10 (high satisfaction) Likert scale. Higher scores represent a better outcome.

Sponsors and collaborators

Lead sponsor

Brigham and Women's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Oct 13, 2022
Registry last updated
Mar 26, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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