Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05579509
Study type Interventional
Source Brigham and Women's Hospital
Contact Yun-Yun K Chen, MD
Phone 617-651-0932
Email ykchen@partners.org
Status Recruiting
Phase Early Phase 1
Start date October 1, 2022
Completion date July 2024

See also
  Status Clinical Trial Phase
Not yet recruiting NCT06269926 - Cognitive Behavioral Therapy for Chronic Pain in Adults With Cerebral Palsy N/A
Completed NCT03644810 - The Association Between Conditioned Pain Modulation and Pain Catastrophizing in Chronic Low Back Pain N/A
Recruiting NCT05571215 - The Effect of Combining Pain Neuroscience Education and Transcranial Direct Current Stimulation on Pain Catastrophizing, Kinesiophobia, and Pain in Patients With Chronic Low Back Pain N/A
Completed NCT03763734 - High-Dose Steroid for Knee Arthroplasty Patients Expected to Have Postoperative Pain Phase 4
Completed NCT03763760 - High-Dose Steroid for Hip Arthroplasty Patients Expected to Have Postoperative Pain Phase 4
Completed NCT02925754 - Catastrophism Among Chronic Pain Patients in Rheumatology N/A