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Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06005480
Enrollment
40
Registered
2023-08-22
Start date
2023-09-28
Completion date
2024-05-28
Last updated
2025-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy, Pain, Acute, Regional Anesthesia Morbidity

Keywords

Healthy volunteer, Regional anesthesia, Rebound pain

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.

Interventions

DRUGMepivacaine

Injection of 1.5% Mepivacaine in nerve block

Sponsors

Brigham and Women's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

Participants will be randomized to which arm will receive a nerve block.

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Heat pain detection threshold at time 1 hr1 hour after nerve block resolutionHeat pain detection threshold (°C) between block arm and control arm using a heat probe at 1 hour after nerve block resolution

Secondary

MeasureTime frameDescription
Pressure pain threshold and tolerance0-3 hours after nerve block resolutionPressure 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
Temporal summation and sharp pain0-3 hours after nerve block resolutionTemporal 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
Light touch detection0-3 hours after nerve block resolutionLight 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
Light touch pain threshold0-3 hours after nerve block resolutionLight 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
Heat pain detection threshold and tolerance0-3 hours after nerve block resolutionHeat 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

Other

MeasureTime frameDescription
Temperature change6-8 hoursTo observe the change in temperature between block arm and control arm (°C) pre, during, and post nerve block
Patient's experiences with nerve block6-8 hoursSemi-structured interviews will be used to explore patient's experiences with nerve block placement using an immersion/crystallization approach to identify emergent themes
Pain catastrophizing and gender differences6-8 hoursCorrelation between situational pain catastrophizing (0-24 scale) and gender

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026