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Block upper extremity (arm) for Healthy Subjects

Phase 1
Recruiting
Led By Yun-Yun K Chen, MD
Research Sponsored by Brigham and Women's Hospital
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age ≥ 18 years old, ≤ 65 years old
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6-8 hours
Awards & highlights

Study Summary

This trial is studying the effects of a nerve block in the arm during surgery. Nerve blocks are injections that numb the area and can help reduce pain after surgery. However, some patients may experience increased

Who is the study for?
This trial is for healthy adults aged 18 to 65 with a BMI between 18 and 35 who speak English. Participants must be willing to undergo psychological and physical pain assessments, as well as receive a nerve block injection.Check my eligibility
What is being tested?
The study is testing whether the use of Mepivacaine for regional anesthesia in the arm can lead to increased sensitivity to pain or 'rebound pain' after the numbing effect wears off.See study design
What are the potential side effects?
Potential side effects may include discomfort at the injection site, temporary numbness or weakness in the affected limb, and an increase in pain sensation once the anesthesia subsides.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 18 and 65 years old.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6-8 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-8 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Heat pain detection threshold at time 1 hr
Secondary outcome measures
Heat pain detection threshold and tolerance
Light touch detection
Light touch pain threshold
+2 more
Other outcome measures
Pain catastrophizing and gender differences
Patient's experiences with nerve block
Temperature change

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Block upper extremity (arm)Experimental Treatment1 Intervention
Upper extremity with a nerve block
Group II: Control upper extremity (arm)Active Control1 Intervention
Upper extremity without a nerve block
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mepivacaine
2013
Completed Phase 4
~23660

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Brigham and Women's HospitalLead Sponsor
1,616 Previous Clinical Trials
11,470,910 Total Patients Enrolled
Yun-Yun K Chen, MDPrincipal InvestigatorBrigham and Women's Hospital
2 Previous Clinical Trials
316 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current participation count in this clinical trial?

"Indeed, the information available on clinicaltrials.gov indicates that this trial is actively seeking participants. The trial was first posted on September 28, 2023 and last updated on January 2, 2024. The study aims to recruit a total of 40 patients from a single site."

Answered by AI

What are the associated risks and potential harm of Block upper extremity (arm) procedure for patients?

"Based on the phase of this trial, which is Phase 1, our team at Power estimates the safety of Block upper extremity (arm) to be a score of 1. This indicates that there is limited data supporting both safety and efficacy for this intervention."

Answered by AI

Is the inclusion criteria for this study limited to individuals below the age of 75?

"To be eligible for this study, individuals must fall within the age range of 18 to 65. It is worth noting that there are a total of 74 clinical trials specifically designed for participants under the age of 18 and an additional 471 trials targeting patients over the age of 65."

Answered by AI

Are participants currently being sought for enrollment in this ongoing medical study?

"Indeed, the information available on clinicaltrials.gov confirms that this particular clinical trial is actively seeking individuals to participate. The initial posting of the study was made on September 28th, 2023, and it has since been last modified on January 2nd, 2024. For this research endeavor, a total of 40 participants are sought after exclusively at one designated site."

Answered by AI

What are the specific criteria that individuals must meet in order to be eligible for participation in this trial?

"The recruitment for this clinical trial aims to enroll 40 individuals who have experienced complications related to regional anesthesia, and their ages should fall between 18 and 65. Notably, prospective participants must meet the following requirements: a body mass index (BMI) greater than 18 but less than 35, proficiency in spoken and written English, being at least 18 years of age but no more than 65 years old, willingness to undergo psychophysical assessments such as quantitative sensory testing (QST) and pain questionnaires, as well as readiness to receive nerve block procedures."

Answered by AI

Who else is applying?

What site did they apply to?
Brigham and Women's Hospital
What portion of applicants met pre-screening criteria?
Met criteria
Recent research and studies
clinicaltrials.govStudy
Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers
Yun-Yun K. Chen 2023. "Understanding Rebound Pain After Regional Anesthesia Resolution in Healthy Volunteers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06005480.
All > Acute Pain
~20 spots leftby Dec 2024
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