Phase 4
N=30
Peripheral Nerve Blocks for Above-the-knee Amputations
Peripheral Vascular Diseases · Hyperglycaemia (Diabetic) · Hypertension · Coronary Artery Disease · Pulmonary Disease, Chronic Obstructive
Bottom Line
View on ClinicalTrials.gov: NCT03404180 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Jan 2026
Primary outcome: Primary: Peripheral Nerve Block Success as a Primary Anesthetic — 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Peripheral nerve block (Procedure); Intravenous Sedatives (Drug); Lateral femoral cutaneous nerve blocks (Procedure); Obturator nerve blocks (Procedure)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Florida
- Primary completion
- Dec 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Peripheral Nerve Block Success as a Primary Anesthetic |
1 | — |
| SECONDARY Mortality |
1 | — |
Summary
Surgery performed with nerve blocks and sedation may be safer and provide better pain control compared to general anesthesia and opioid therapy in high-risk patient populations such as elderly and troubled with peripheral vascular disease, diabetes, hypertension, coronary artery disease, and chronic obstructive pulmonary disease (COPD).
Eligibility Criteria
Inclusion Criteria
- Patients undergoing above-the-knee amputation or knee disarticulation
- Ability to understand and provide informed consent
Exclusion Criteria
- Patient refusal or inability to provide informed consent
- True allergy, not sensitivity, to any of the following substances:
- - Local anesthetics
- - Propofol or other sedative agents
- - General anesthetic agents
- Pregnancy
- Severe hepatic impairment
- Evidence of infection at or near the proposed needle insertion site
- Any sensorimotor deficit, whether acute or chronic, as determined by the PI
- Chronic use of opioid medication
- BMI ≥ 35
Data sourced from ClinicalTrials.gov (NCT03404180). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.