Personalizing Preprocedural Sedation for Regional Anesthesia

NCT ID: NCT05579509

Last Updated: 2025-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-22
• Study Completion Date: 2024-05-24

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.

Detailed 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.

Conditions

Catastrophizing Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

High Pain Catastrophizing

Based on the Pain Catastrophizing Scale (PCS)

Group Type: EXPERIMENTAL

Midazolam and Fentanyl

Intervention Type: 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.

Educational Reassurance

Intervention Type: 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).

Low Pain Catastrophizing

Based on the Pain Catastrophizing Scale (PCS)

Group Type: EXPERIMENTAL

Midazolam and Fentanyl

Intervention Type: 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.

Educational Reassurance

Intervention Type: 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).

Interventions

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.

Intervention Type: DRUG

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).

Intervention Type: BEHAVIORAL

Other Intervention Names

Versed; Sublimaze

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yun-Yun K. Chen

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Yun-Yun K Chen, MD

Role: PRINCIPAL_INVESTIGATOR

Brigham and Women's Hospital

Locations

Brigham and Women's Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40473409 (View on PubMed)

Other Identifiers

2022P001901

Identifier Type: -

Identifier Source: org_study_id