Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers

NCT06005480 | Completed Phase 1 FDA Drug

• 1 other identifier: 2023P001767
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Regional Anesthesia Morbidity; Pain, Acute; Healthy

Keywords

Healthy volunteer; Regional anesthesia; Rebound pain

Outcome Measures

Primary Outcomes (1)

• Heat pain detection threshold at time 1 hr

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

  1 hour after nerve block resolution

Secondary Outcomes (5)

• 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

• Light touch detection

  0-3 hours after nerve block resolution

• Light touch pain threshold

  0-3 hours after nerve block resolution

Other Outcomes (3)

• Temperature change

  6-8 hours

• Patient's experiences with nerve block

  6-8 hours

• Pain catastrophizing and gender differences

  6-8 hours

Study Arms (2)

Block upper extremity (arm)

EXPERIMENTAL

Upper extremity with a nerve block

Drug: Mepivacaine

Control upper extremity (arm)

NO INTERVENTION

Upper extremity without a nerve block

Interventions

Mepivacaine DRUG

Injection of 1.5% Mepivacaine in nerve block

Also known as: Prilocaine

Block upper extremity (arm)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Links

• Mass General Brigham Rally Flyer

MeSH Terms

Conditions

Acute Pain

Interventions

Mepivacaine; Prilocaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Yun-Yun K Chen, MD

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

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

Study Record Dates

• First Submitted: July 16, 2023
• First Posted: August 22, 2023
• Study Start: September 28, 2023
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: November 5, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)