ClinicalTrials.gg
CompletedNCT03404180Updated Jan 8, 2026Results posted

Peripheral Nerve Blocks for Above-the-knee Amputations

A Phase 4 interventional study of Peripheral nerve block and Intravenous Sedatives in Peripheral Vascular Diseases, Hyperglycaemia (Diabetic) and Hypertension, sponsored by University of Florida. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-08.

Sponsored by University of Florida · Phase 4, Interventional, and Basic science

Phase
Phase 4
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 187 studies in Peripheral Vascular Diseases with a site in United States — 18 open to participants now, 23 under way, 2 of them phase 3. Peripheral Vascular Diseases · United States.

Enrollment
113th of 158
30 · median 82
Started
2018
with 6 others
Phase 4
11 of 187
2 open now
Registered
137th of 187
by date

Among the 187 studies in Peripheral Vascular Diseases with a site in United States, this one is the 113th largest by enrollment of the 158 interventional ones that give a count, is one of 7 that started in 2018, is one of 11 in phase 4, and was the 137th registered.

Peripheral Vascular Diseases

443 studies on the registry are indexed under Peripheral Vascular Diseases; 44 are open to participants now.

Browse Peripheral Vascular Diseases studies →

Open to participants now

18 of the 187 studies in Peripheral Vascular Diseases with a site in United States are open now. Recruiting first, the newest first:

13 more — sign in →

All 18 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 32 Peripheral Vascular Diseases studies recruiting now, 19 (59%) set no upper age limit and 4 (13%) stop at 75 or younger; 2 take children under 18; 4 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

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02

Study 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).

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.

03

Conditions studied

  • Peripheral Vascular Diseases
  • Hyperglycaemia (Diabetic)
  • Hypertension
  • Coronary Artery Disease
  • Pulmonary Disease, Chronic Obstructive
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing above-the-knee amputation or knee disarticulation
  • Ability to understand and provide

Exclusion criteria

Exclusion Criteria:

  • Patient refusal or inability to provide
  • 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
  • ≥ 35
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Phase
Phase 4
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    Peripheral nerve block

    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.

    Procedure: Peripheral nerve block · Drug: Intravenous Sedatives · Procedure: Lateral femoral cutaneous nerve blocks · Procedure: Obturator nerve blocks

Interventions

  • ProcedurePeripheral nerve block

    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 sedation using propofol or dexmedetomidine will be administered.

    Also known as: Propofol or Dexmedetomidine

  • ProcedureLateral femoral cutaneous nerve blocks

    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.

  • ProcedureObturator nerve blocks

    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.

06

What researchers measure

Primary outcomes

  1. Peripheral Nerve Block Success as a Primary Anesthetic

    Time frame: Intraoperative period (typically one to three hours)

Secondary outcomes

  1. Mortality

    The medical record will be reviewed to assess 30-day mortality.

    Time frame: Changes from baseline through 30 days post-operative.

07

Results

Posted Jan 8, 2026

Participant flow

Participant flow — Overall Study
MilestonePeripheral Nerve Block
Started30
Completed30
Not completed0

Outcome measures

PrimaryPeripheral Nerve Block Success as a Primary Anesthetic
Time frame:
Intraoperative period (typically one to three hours)
Reported as:
Count of participants · Participants
Peripheral Nerve Block Success as a Primary Anesthetic
ParticipantsPeripheral Nerve Block
Peripheral Nerve Block Success as a Primary Anesthetic1
SecondaryMortality

The medical record will be reviewed to assess 30-day mortality.

Time frame:
Changes from baseline through 30 days post-operative.
Reported as:
Count of participants · Participants
Mortality
ParticipantsPeripheral Nerve Block
Mortality1

Adverse events

Collected over Adverse events were monitored from informed consent until 30 days after surgery. Active adverse events assessments occurred at Day 30 post-enrollment (±7 days).. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Peripheral Nerve Block1/30 (3.3%)0/30 (0%)0/30 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Peripheral Nerve Block
<=18 years0
Between 18 and 65 years8
>=65 years22
Age, Continuous
Age, Continuous(years)Peripheral Nerve Block
Mean69.9 ± 8.7
Sex: Female, Male
Sex: Female, Male(Participants)Peripheral Nerve Block
Female0
Male30
Race and Ethnicity Not Collected
Race and Ethnicity Not Collected(Participants)Peripheral Nerve Block
Region of Enrollment
Region of Enrollment(Participants)Peripheral Nerve Block
United States30
08

Study locations

1 site
  • University of Florida
    Gainesville, Florida 32611, United States
09

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Feb 2018 to primary completion in Dec 2024, 82 months.

Results were first posted in Jan 2026, 1 year after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 20, 2017
First posted
Jan 19, 2018
StartActual
Feb 9, 2018
Primary completionActual
Dec 18, 2024
CompletionActual
Dec 18, 2024
Results first posted
Jan 8, 2026
Last update
Jan 8, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 8, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03404180
Responsible party
Sponsor
First posted
Jan 19, 2018
Start date
Feb 9, 2018
Primary completion
Dec 18, 2024
Completion
Dec 18, 2024
Results posted
Jan 8, 2026
Last update
Jan 8, 2026

Study contacts

José R Soberón, MD
principal investigator · Malcom Randall VA Medical Center

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

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Studies of the drug tested here: Hypnotics and Sedatives

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