Personalizing Preprocedural Sedation for Regional Anesthesia

Catastrophizing Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05579509
• Other study ID #: 2022P001901
• Status: Recruiting
• Phase: Early Phase 1
• Start date: October 1, 2022
• Est. completion date: July 2024

Study information

• Verified date: June 2024
• Source: Brigham and Women's Hospital
• Contact: Yun-Yun K Chen, MD
• Phone: 617-651-0932
• Email: ykchen[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: July 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catastrophizing Pain

Intervention

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).

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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