Back to resultsUnderstanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
Primary Purpose
Regional Anesthesia Morbidity, Pain, Acute, Healthy
Status
Not yet recruiting
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Mepivacaine
Sponsored by
About this trial
This is an interventional basic science trial for Regional Anesthesia Morbidity focused on measuring Healthy volunteer, Regional anesthesia, Rebound pain
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Block upper extremity (arm)
Control upper extremity (arm)
Arm Description
Upper extremity with a nerve block
Upper extremity without a nerve block
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Heat pain detection threshold and tolerance
Heat 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
Pressure pain threshold and tolerance
Pressure 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 pain
Temporal 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 detection
Light 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 threshold
Light 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
Full Information
NCT ID
NCT06005480
First Posted
July 16, 2023
Last Updated
September 15, 2023
Sponsor
Brigham and Women's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT06005480
Brief Title
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
Official Title
Understanding Rebound Pain After Regional Anesthesia Resolution: Mechanistic Trial in Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Brigham and Women's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Regional Anesthesia Morbidity, Pain, Acute, Healthy
Keywords
Healthy volunteer, Regional anesthesia, Rebound pain
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to which arm will receive a nerve block.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Block upper extremity (arm)
Arm Type
Experimental
Arm Description
Upper extremity with a nerve block
Arm Title
Control upper extremity (arm)
Arm Type
No Intervention
Arm Description
Upper extremity without a nerve block
Intervention Type
Drug
Intervention Name(s)
Mepivacaine
Other Intervention Name(s)
Prilocaine
Intervention Description
Injection of 1.5% Mepivacaine in nerve block
Primary Outcome Measure Information:
Title
Heat pain detection threshold at time 1 hr
Description
Heat pain detection threshold (°C) between block arm and control arm using a heat probe at 1 hour after nerve block resolution
Time Frame
1 hour after nerve block resolution
Secondary Outcome Measure Information:
Title
Heat pain detection threshold and tolerance
Description
Heat 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
Time Frame
0-3 hours after nerve block resolution
Title
Pressure pain threshold and tolerance
Description
Pressure 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
Time Frame
0-3 hours after nerve block resolution
Title
Temporal summation and sharp pain
Description
Temporal 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
Time Frame
0-3 hours after nerve block resolution
Title
Light touch detection
Description
Light 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
Time Frame
0-3 hours after nerve block resolution
Title
Light touch pain threshold
Description
Light 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
Time Frame
0-3 hours after nerve block resolution
Other Pre-specified Outcome Measures:
Title
Temperature change
Description
To observe the change in temperature between block arm and control arm (°C) pre, during, and post nerve block
Time Frame
6-8 hours
Title
Patient's experiences with nerve block
Description
Semi-structured interviews will be used to explore patient's experiences with nerve block placement using an immersion/crystallization approach to identify emergent themes
Time Frame
6-8 hours
Title
Pain catastrophizing and gender differences
Description
Correlation between situational pain catastrophizing (0-24 scale) and gender
Time Frame
6-8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yun-Yun K Chen, MD
Phone
6176510932
Email
ykchen@mgb.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yun-Yun K Chen, MD
Organizational Affiliation
Brigham and Women's Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
https://rally.massgeneralbrigham.org/study/rebound_pain_nerve_block
Description
Mass General Brigham Rally Flyer
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Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
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