Ropivacaine without Epinephrine for Erector Spinae Plane Block

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Milton S. Hershey Medical Center, Hershey, PAErector Spinae Plane BlockRopivacaine - Drug
Eligibility
18 - 60
All Sexes
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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.

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

4 Primary · 3 Secondary · Reporting Duration: These samples will be repeated at 20, 40, 60, 90, 120, and 240 minutes after completion of the injection of active drug.

0 to 360 minutes from the time of the ESP block
Duration of sensory loss
Extent of dermatomal sensory loss
Day 3
Any adverse effects or side effects related to injection of the medications
30 and 90 minutes from the time of the ESP block
Anatomical extent of injectate spread using MRI
These samples will be repeated at 20, 40, 60, 90, 120, and 240 minutes after completion of the injection of active drug.
Venous plasma concentration of ropivacaine at periodic time intervals
Up to 360 minutes from the time of the ESP block
Blood pressure at periodic time intervals
ECG at periodic time intervals

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

Ropivacaine without Epinephrine
1 of 2
Ropivacaine with Epinephrine
1 of 2

Active Control

24 Total Participants · 2 Treatment Groups

Primary Treatment: Ropivacaine without Epinephrine · No Placebo Group · Phase 4

Ropivacaine without Epinephrine
Drug
ActiveComparator Group · 1 Intervention: Ropivacaine · Intervention Types: Drug
Ropivacaine with EpinephrineActiveComparator Group · 2 Interventions: Ropivacaine, Epinephrine · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: these samples will be repeated at 20, 40, 60, 90, 120, and 240 minutes after completion of the injection of active drug.

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor
466 Previous Clinical Trials
2,785,810 Total Patients Enrolled
Sanjib Adhikary, MDPrincipal InvestigatorMilton S. Hershey Medical Center

Eligibility Criteria

Age 18 - 60 · All Participants · 3 Total Inclusion Criteria

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Frequently Asked Questions

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer

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." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.