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Clinical Trials/NCT06005480
NCT06005480
Completed
Phase 1

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

Brigham and Women's Hospital1 site in 1 country40 target enrollmentSeptember 28, 2023

Overview

Phase
Phase 1
Intervention
Mepivacaine
Conditions
Regional Anesthesia Morbidity
Sponsor
Brigham and Women's Hospital
Enrollment
40
Locations
1
Primary Endpoint
Heat pain detection threshold at time 1 hr
Status
Completed
Last Updated
5 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 28, 2023
End Date
May 28, 2024
Last Updated
5 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yun-Yun K. Chen

Principal Investigator

Brigham and Women's Hospital

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

Arms & Interventions

Block upper extremity (arm)

Upper extremity with a nerve block

Intervention: Mepivacaine

Outcomes

Primary Outcomes

Heat pain detection threshold at time 1 hr

Time Frame: 1 hour after nerve block resolution

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

Secondary Outcomes

  • Light touch detection(0-3 hours after nerve block resolution)
  • Light touch pain threshold(0-3 hours after nerve block resolution)
  • Heat pain detection threshold and tolerance(0-3 hours after nerve block resolution)
  • Pressure pain threshold and tolerance(0-3 hours after nerve block resolution)
  • Temporal summation and sharp pain(0-3 hours after nerve block resolution)

Study Sites (1)

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