Personalizing Preprocedural Sedation for Regional Anesthesia

NCT05579509 | Completed Early Phase 1 FDA Drug

• 1 other identifier: 2022P001901
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Catastrophizing Pain

Keywords

Catastrophizing; Regional anesthesia; Nerve block; Preprocedural sedation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction

  Immediately following procedure

Study Arms (2)

High Pain Catastrophizing

EXPERIMENTAL

Based on the Pain Catastrophizing Scale (PCS)

Drug: Midazolam and Fentanyl; Behavioral: Educational Reassurance

Low Pain Catastrophizing

EXPERIMENTAL

Based on the Pain Catastrophizing Scale (PCS)

Drug: Midazolam and Fentanyl; Behavioral: Educational Reassurance

Interventions

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.

Also known as: Versed, Sublimaze

High Pain Catastrophizing; Low Pain Catastrophizing

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).

High Pain Catastrophizing; Low Pain Catastrophizing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age≥18
• English speaking
• Willingness to undergo psychophysical testing
• Willingness to have nerve block performed
• Surgical or procedural patient
• Single shot nerve block

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (1)

• 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.

  PMID: 40473409 DERIVED

MeSH Terms

Interventions

Midazolam; Fentanyl

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring

Study Officials

• Yun-Yun K Chen, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Parallel and crossover design. Subjects in Arm 2 may crossover to Arm 1 if they receive pharmacologic sedation.

Study Record Dates

• First Submitted: September 29, 2022
• First Posted: October 13, 2022
• Study Start: October 22, 2022
• Primary Completion: May 24, 2024
• Study Completion: May 24, 2024
• Last Updated: March 26, 2025

Record last verified: 2025-03

Locations

US (1)