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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 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

Find a Location

Who is running the clinical trial?

University of FloridaLead Sponsor
1,352 Previous Clinical Trials
723,414 Total Patients Enrolled
US Department of Veterans AffairsFED
871 Previous Clinical Trials
497,911 Total Patients Enrolled
José R Soberón, MDPrincipal InvestigatorMalcom Randall VA Medical Center
2 Previous Clinical Trials
75 Total Patients Enrolled
~0 spots leftby Aug 2024
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