Peripheral Vascular DiseasesPhase 4NCT03404180
Peripheral Nerve Blocks for Above-the-knee Amputations
A Phase 4 study testing Peripheral nerve block, Intravenous Sedatives and Lateral femoral cutaneous nerve blocks in people with Peripheral Vascular Diseases and Hyperglycaemia (Diabetic), run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension
- What is being tested?
- Peripheral nerve block, Intravenous Sedatives and Lateral femoral cutaneous nerve blocks
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2018to 18 Dec 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing above-the-knee amputation or knee disarticulation
- Ability to understand and provide informed consent
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Peripheral Nerve Blocks for Upper Leg Amputations
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).
Read the detailed description
Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.
- Conditions
- Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
- Being tested
- Peripheral nerve block, Intravenous Sedatives, Lateral femoral cutaneous nerve blocks, Obturator nerve blocks
- Medical subject headings
- Peripheral Vascular Diseases, Hyperglycemia, Hypertension, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peripheral nerve blockProcedure or surgery
All enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed.
Intravenous SedativesDrug
Also called Propofol or Dexmedetomidine
Intravenous sedation using propofol or dexmedetomidine will be administered.
Lateral femoral cutaneous nerve blocksProcedure or surgery
After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.
Obturator nerve blocksProcedure or surgery
After administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| Peripheral nerve block | Experimental | 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. Receives: Procedure: Peripheral nerve block; Drug: Intravenous Sedatives; Procedure: Lateral femoral cutaneous nerve blocks; Procedure: Obturator nerve blocks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral Nerve Block Success as a Primary Anesthetic
Measured: Intraoperative period (typically one to three hours)
Secondary outcomes (1)
Mortality
The medical record will be reviewed to assess 30-day mortality.
Measured: Changes from baseline through 30 days post-operative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start9 Feb 2018
- Primary completion18 Dec 2024
- Study completion18 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Peripheral Vascular DiseasesStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot clinical trial with a single arm
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Responsible party
- Sponsor
- Investigators
- José R Soberón, MD, Principal investigator, Malcom Randall VA Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404180
- Sponsor's protocol ID
- IRB201702402
- Other IDs
- OCR18952
- Status last verified
- Aug 2025
- First submitted
- 20 Dec 2017
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Nerve Blocks for Upper Leg Amputations
- ClinicalTrials.gov ID
- NCT03404180
- Acronym / sponsor ID
- IRB201702402
- Conditions
- Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs
- Study start
- 9 Feb 2018 (actual)
- Primary completion
- 18 Dec 2024 (actual)
- Study completion
- 18 Dec 2024 (actual)
- First posted
- 19 Jan 2018 (actual)
- Results
- Posted 8 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
Avoidance of general anesthesia in certain high-risk patient populations may have additional benefits beyond improved postoperative pain scores and analgesic consumption. The primary objective of this research will be to evaluate the ability of the femoral, sciatic, lateral femoral cutaneous nerve (LFCN), and obturator blocks to provide surgical anesthesia.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot clinical trial with a single arm
| Arm | Type | Receives |
|---|---|---|
| Peripheral nerve block | Experimental | Procedure: Peripheral nerve block, Drug: Intravenous Sedatives, Procedure: Lateral femoral cutaneous nerve blocks, Procedure: Obturator nerve blocksProspectively 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients undergoing above-the-knee amputation or knee disarticulation
- Ability to understand and provide informed consent
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peripheral nerve blockAll enrollees will have ultrasound-guided femoral and sciatic nerve blocks placed per current practice at research site. Single-injection obturator and lateral femoral cutaneous nerve blocks will also be performed. | Procedure or surgery | Peripheral nerve block |
| Intravenous SedativesAlso: Propofol or DexmedetomidineIntravenous sedation using propofol or dexmedetomidine will be administered. | Drug | Peripheral nerve block |
| Lateral femoral cutaneous nerve blocksAfter administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. | Procedure or surgery | Peripheral nerve block |
| Obturator nerve blocksAfter administration of intravenous sedation, lateral femoral cutaneous and obturator nerve blocks (in addition to the femoral and sciatic catheters) will be performed under ultrasound guidance. | Procedure or surgery | Peripheral nerve block |
Primary outcome
Peripheral Nerve Block Success as a Primary Anesthetic
Time frame: Intraoperative period (typically one to three hours)
1 secondary outcome
Mortality
Time frame: Changes from baseline through 30 days post-operative.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
José R Soberón, MD principal investigator
Malcom Randall VA Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Peripheral nerve block, Intravenous Sedatives and Lateral femoral cutaneous nerve blocks in people with Peripheral Vascular Diseases and Hyperglycaemia (Diabetic), run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral Nerve Block Success as a Primary Anesthetic (time frame: Intraoperative period (typically one to three hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.