Clinical trial NCT06005480: Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
Official title: Understanding Rebound Pain After Regional Anesthesia Resolution: Mechanistic Trial in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Regional Anesthesia Morbidity
Pain, Acute
Healthy
Keywords: Healthy volunteer
Regional anesthesia
Rebound pain
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2023-08-22
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to which arm will receive a nerve block.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Heat pain detection threshold at time 1 hr
timeFrame: 1 hour after nerve block resolution
Secondary outcomes:
measure: Heat pain detection threshold and tolerance
timeFrame: 0-3 hours after nerve block resolution
measure: Pressure pain threshold and tolerance
timeFrame: 0-3 hours after nerve block resolution
measure: Temporal summation and sharp pain
timeFrame: 0-3 hours after nerve block resolution
measure: Light touch detection
timeFrame: 0-3 hours after nerve block resolution
measure: Light touch pain threshold
timeFrame: 0-3 hours after nerve block resolution
Other outcomes:
measure: Temperature change
timeFrame: 6-8 hours
measure: Patient's experiences with nerve block
timeFrame: 6-8 hours
measure: Pain catastrophizing and gender differences
timeFrame: 6-8 hours
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Yun-Yun K Chen, MD
role: PRINCIPAL_INVESTIGATOR
References: