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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

Must not have

Severe hepatic impairment

BMI ≥ 35

Timeline

Screening 3 weeks

Treatment Varies

Follow Up changes from baseline through 48 hours post procedure.

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Drug Has Already Been Approved

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.

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.

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

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I am having an amputation above my knee.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have severe liver problems.

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My BMI is 35 or higher.

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I cannot or do not want to give permission for treatment.

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I have an infection where they might insert a needle.

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I regularly use opioid medication.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Analysis of pain scores

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

Secondary study objectives

Mortality

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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 / 6Eligibility criteria met