Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers

Last updated: June 14, 2024
Sponsor: Brigham and Women's Hospital
Overall Status: Completed

Phase

1

Condition

Pain

Acute Pain

Treatment

Mepivacaine

Clinical Study ID

NCT06005480
2023P001767
  • Ages 18-65
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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

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 upperextremity

  • 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

Total Participants: 58
Treatment Group(s): 1
Primary Treatment: Mepivacaine
Phase: 1
Study Start date:
September 28, 2023
Estimated Completion Date:
May 28, 2024

Study 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.

Connect with a study center

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

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