Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-28

Study Completion Date

2024-05-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Regional Anesthesia Morbidity Pain, Acute Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Block upper extremity (arm)

Upper extremity with a nerve block

Group Type EXPERIMENTAL

Mepivacaine

Intervention Type DRUG

Injection of 1.5% Mepivacaine in nerve block

Control upper extremity (arm)

Upper extremity without a nerve block

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Mepivacaine

Injection of 1.5% Mepivacaine in nerve block

Intervention Type DRUG

Other Intervention Names

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Prilocaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes