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NCT06005480 Clinical Trial

Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers

Healthy Clinical Trial

Official title:
Understanding Rebound Pain After Regional Anesthesia Resolution: Mechanistic Trial in Healthy Volunteers

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06005480
Other study ID # 2023P001767
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date September 28, 2023
Est. completion date December 2024

Study information
Verified date January 2024
Source Brigham and Women's Hospital
Contact Yun-Yun K Chen, MD
Phone 6176510932
Email ykchen@mgb.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Regional anesthesia decreases postoperative pain scores and opioid consumption, and may prevent chronic pain after surgery in patients undergoing surgery. However, some patients experience an increase of pain into the severe range when the nerve block wears off, also known as rebound pain. The investigators are studying if a nerve block (numbing injection) in the arm causes hyperalgesia (increased pain) when the nerve block is wearing off.

Description:

This is a prospective, randomized study in healthy volunteers who will undergo sensory testing using quantitative sensory testing (QST), complete psychosocial and pain questionnaires, and ultrasound-guided peripheral nerve block of the arm (axillary nerve block) in a supervised, monitored setting (BWH Clinical Investigation Center). The investigators plan to assess the association between different QST modalities at different time points pre- and post-nerve block resolution. Semi-structured interviews and qualitative analysis will be used to explore patient's experiences with nerve block placement.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date December 2024
Est. primary completion date December 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Age = 18 years old, = 65 years old - BMI >18, < 35 - Able to speak and understand English - Willingness to undergo psychophysical testing (e.g., QST, pain questionnaires) - Willingness to have nerve block performed Exclusion Criteria: - Ongoing acute or chronic pain in upper extremities - Skin or tissue infection affecting upper extremities - Previous hypersensitivity to mepivacaine or lidocaine - Previous neuropathy (numbness, paresthesia, or motor weakness) in either upper extremity - Loss of any limb - Bleeding issues or bleeding disorder - History of alcohol or drug abuse - Currently pregnant or breastfeeding - History of seizure or epilepsy

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Mepivacaine
Injection of 1.5% Mepivacaine in nerve block

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
Other Temperature change To observe the change in temperature between block arm and control arm (°C) pre, during, and post nerve block 6-8 hours
Other Patient's experiences with nerve block Semi-structured interviews will be used to explore patient's experiences with nerve block placement using an immersion/crystallization approach to identify emergent themes 6-8 hours
Other Pain catastrophizing and gender differences Correlation between situational pain catastrophizing (0-24 scale) and gender 6-8 hours
Primary Heat pain detection threshold at time 1 hr Heat pain detection threshold (°C) between block arm and control arm using a heat probe at 1 hour after nerve block resolution 1 hour after nerve block resolution
Secondary Heat pain detection threshold and tolerance Heat pain detection threshold and tolerance (°C) between block arm and control arm using a heat probe at different time points up to 3 hours nerve block resolution 0-3 hours after nerve block resolution
Secondary Pressure pain threshold and tolerance Pressure pain threshold and tolerance (N of force) between block arm and control arm using an algometer at different time points up to 3 hours nerve block resolution 0-3 hours after nerve block resolution
Secondary Temporal summation and sharp pain Temporal summation and sharp pain (evaluated by numerical rating scale 0-10 pain score) between block arm and control arm using a pinprick device at different time points up to 3 hours nerve block 0-3 hours after nerve block resolution
Secondary Light touch detection Light touch detection (mN of force) between block arm and control arm using von Frey filaments at different time points up to 3 hours nerve block 0-3 hours after nerve block resolution
Secondary Light touch pain threshold Light touch pain threshold (mN of force) between block arm and control arm using von Frey filaments at different time points up to 3 hours nerve block 0-3 hours after nerve block resolution
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