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: Completed

Administrative data

• NCT number: NCT06005480
• Other study ID #: 2023P001767
• Status: Completed
• Phase: Phase 1
• Start date: September 28, 2023
• Est. completion date: May 28, 2024

Study information

• Verified date: June 2024
• Source: Brigham and Women's Hospital
• Contact: n/a
• Is FDA regulated: No
• 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: Completed
• Enrollment: 58
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 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

Related Conditions & MeSH terms

• Acute Pain
• Healthy
• Pain, Acute
• Regional Anesthesia Morbidity

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

External Links

•   Mass General Brigham Rally Flyer