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Peripheral Nerve Blocks for Amputations

Phase 4

Recruiting

Led By José R Soberón, MD

Research Sponsored by University of Florida

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patients undergoing above-the-knee amputation or knee disarticulation

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes from baseline through 48 hours post procedure.

Awards & highlights

Study Summary

This trial found that surgery with nerve blocks and sedation was safer and provided better pain control compared to general anesthesia and opioid therapy in high-risk patient populations.

Who is the study for?

This trial is for patients needing above-the-knee amputations who can understand and agree to the study. It's not for those with chronic opioid use, severe liver issues, a BMI over 35, sensorimotor deficits, or true allergies to local anesthetics or sedatives.Check my eligibility

What is being tested?

The study tests if using nerve blocks and sedatives during surgery offers better safety and pain control than general anesthesia in patients with conditions like diabetes, high blood pressure, heart disease, COPD.See study design

What are the potential side effects?

Possible side effects include discomfort at the injection site of the nerve block, allergic reactions to medications used (if sensitivity exists), and typical risks associated with sedation such as nausea or drowsiness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am having an amputation above my knee.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ changes from baseline through 48 hours post procedure.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~changes from baseline through 48 hours post procedure.

This trial's timeline: 3 weeks for screening, Varies for treatment, and changes from baseline through 48 hours post procedure. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Analysis of pain scores

Chi-squared tests of peripheral nerve block success as a primary anesthetic

Secondary outcome measures

Mortality

Trial Design

1Treatment groups

Experimental Treatment

Group I: Peripheral nerve blockExperimental Treatment4 Interventions

Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered Intravenous sedatives using propofol or dexmedetomidine and have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator nerve blocks and lateral femoral cutaneous nerve blocks will also be performed.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Peripheral nerve block

2002

N/A

~192200

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor

1,345 Previous Clinical Trials

718,281 Total Patients Enrolled

US Department of Veterans AffairsFED

870 Previous Clinical Trials

495,911 Total Patients Enrolled

José R Soberón, MDPrincipal InvestigatorMalcom Randall VA Medical Center

2 Previous Clinical Trials

75 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 limit of participants for this trial?

"Affirmative. The clinical trial database shows that this research is actively seeking participants; it was first posted on February 9, 2018 and last updated September 16, 2022. Currently, 1 site needs to enrol 36 patients in total."

Answered by AI

Is recruitment still open for participation in this experiment?

"Affirmative. Per the listing on clinicaltrials.gov, this research project is still accepting participants after being initially posted on February 9th 2018 and updated most recently on September 16th 2022. The trial requires 36 volunteers to be assigned at a single site for completion of the study."

Answered by AI

What potential risks are posed by administration of Intravenous Sedatives?

"There is ample evidence to suggest that Intravenous Sedatives are safe, so it scored a 3 on our 1-3 scale. This drug has also been approved in Phase 4 clinical trials."

Answered by AI

What ailments commonly necessitate treatments with Intravenous Sedatives?

"Intravenous sedatives are generally used as part of a sedative therapy regimen, but they can also be beneficial in cases where anesthesia is needed or to ease the symptoms of certain diseases."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Peripheral Nerve Blocks for Above-the-knee Amputations

2018. "Peripheral Nerve Blocks for Above-the-knee Amputations". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03404180.

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