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Local Anesthetic

ESP Block Anesthesia Distribution for Sensory Blockade

Phase 4
Recruiting
Led By Sanjib Adhikary, MD
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Healthy adults aged 18 to 60 inclusive
Weight between 60 and 100 kg inclusive
Timeline
Screening 3 weeks
Treatment Varies
Follow Up these samples will be repeated at 20, 40, 60, 90, 120, and 240 minutes after completion of the injection of active drug.
Awards & highlights

Study Summary

This trial will study the effects of a T5 ESP block on the body. The primary objectives are to see how far the anesthesia spreads and how long it lasts.

Who is the study for?
Healthy adults aged 18-60, weighing between 60 and 100 kg, and measuring 160 to 190 cm in height can participate. Excluded are pregnant women, those with major surgery history or MRI contraindications, allergies to specific contrast agents or anesthetics, metallic body implants, chronic medication conditions, congenital abnormalities or major trauma in the spine/back area.Check my eligibility
What is being tested?
The study is testing how well a pain block at the T5 level (Erector Spinae Plane Block) works using ropivacaine. It looks at the numbness spread via MRI imaging and monitors changes in vital signs and blood levels of ropivacaine over time. The effect of adding epinephrine is also examined.See study design
What are the potential side effects?
Possible side effects include reactions to ropivacaine such as nerve damage symptoms (numbness beyond expected), low blood pressure due to anesthesia spread, allergic reactions including itching or rash; epinephrine may cause increased heart rate and anxiety.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 60 years old and healthy.
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My weight is between 60 and 100 kg.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~these samples will be repeated at 20, 40, 60, 90, 120, and 240 minutes after completion of the injection of active drug.
This trial's timeline: 3 weeks for screening, Varies for treatment, and these samples will be repeated at 20, 40, 60, 90, 120, and 240 minutes after completion of the injection of active drug. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Anatomical extent of injectate spread using MRI
Duration of sensory loss
Extent of dermatomal sensory loss
+1 more
Secondary outcome measures
Any adverse effects or side effects related to injection of the medications
Blood pressure at periodic time intervals
ECG at periodic time intervals

Trial Design

2Treatment groups
Active Control
Group I: Ropivacaine with EpinephrineActive Control2 Interventions
Group RE will have 20mL of 0.5% Ropivacaine with epinephrine injected at the left or right T5 transverse process.
Group II: Ropivacaine without EpinephrineActive Control1 Intervention
Group R will have 20mL of 0.5% Ropivacaine without epinephrine injected at the left or right T5 transverse process.

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
492 Previous Clinical Trials
2,798,798 Total Patients Enrolled
Sanjib Adhikary, MDPrincipal InvestigatorMilton S. Hershey Medical Center

Media Library

Ropivacaine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT03476642 — Phase 4
Erector Spinae Plane Block Research Study Groups: Ropivacaine with Epinephrine, Ropivacaine without Epinephrine
Erector Spinae Plane Block Clinical Trial 2023: Ropivacaine Highlights & Side Effects. Trial Name: NCT03476642 — Phase 4
Ropivacaine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03476642 — Phase 4

Frequently Asked Questions

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

How extensive is the participation in this clinical experiment?

"Yes, clinicaltrials.gov reveals that this trial is actively soliciting volunteers and has been so since it was initially posted on July 2nd 2019. The study requires 24 participants to be enrolled at two designated centres before the last edit of January 9th 2022."

Answered by AI

What medical issues can be addressed with Ropivacaine unaccompanied by Epinephrine?

"Ropivacaine, unaccompanied by Epinephrine, can be administered to treat hypotension, pupil dilation and cardiac unresponsiveness."

Answered by AI

What data has been gathered from other investigations regarding Ropivacaine without Epinephrine?

"Presently, there are 90 active investigations looking into the utility of Ropivacaine without Epinephrine and 19 studies have reached Phase 3. Though most centres conducting research on this topic are found in Karachi, Sindh; 128 distinct sites across the world are running trials for Ropivacaine without Epinephrine."

Answered by AI

Are there any openings for applicants in this clinical trial?

"Affirmative. According to the information on clinicaltrials.gov, this research initiative is actively searching for participants. The trial was initiated on July 2nd 2019 and has been recently updated as of January 9th 2022; it requires 24 volunteers at two different sites."

Answered by AI

Does this research encompass adults aged 30 or older?

"The parameters for inclusion in this trial limit participants to those between 18 and 60 years of age. There are 16 studies available for minors under 18, and 67 trials targeting individuals over 65."

Answered by AI

Has the Food and Drug Administration approved Ropivacaine without Epinephrine?

"According to our team at Power, Ropivacaine without Epinephrine has been approved for use and thus receives a score of 3 on the safety scale."

Answered by AI

What criteria must a participant fulfill in order to be accepted into this trial?

"For admittance to this trial, applicants must have evidence of the distribution of ropivacaine in erector spinae plane block and be within the age range 18-60 years. A maximum of 24 participants will be accepted into the study."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks
Sanjib D Adhikary 2019. "Distribution, Pharmacokinetics and Extent of Sensory Blockade in ESP Blocks". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03476642.
~1 spots leftby Jul 2024
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