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Personalizing Preprocedural Sedation for Regional Anesthesia

NCT05579509 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2025-03-26

No results posted yet for this study

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

Interventions

DRUG

Midazolam and Fentanyl

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.

BEHAVIORAL

Educational Reassurance

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).

Sponsors & Collaborators

  • Brigham and Women's Hospital

    lead OTHER

Principal Investigators

  • Yun-Yun K Chen, MD · Brigham and Women's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-22
Primary Completion
2024-05-24
Completion
2024-05-24
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05579509 on ClinicalTrials.gov