Peripheral Nerve Blocks for Above-the-knee Amputations

NCT03404180 — Phase 4, Completed, 30 participants, University of Florida

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Peripheral Nerve Blocks for Upper Leg Amputations

Registry	NCT03404180
Status	Completed
Phase	Phase 4
Study type	Interventional; na, single group, masking: none, basic science
Enrollment	30 (Actual)
Sponsor	University of Florida (Other); collaborators: US Department of Veterans Affairs
Conditions	Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension, Coronary Artery Disease, Pulmonary Disease, Chronic Obstructive
Interventions	Peripheral nerve block, Intravenous Sedatives, Lateral femoral cutaneous nerve blocks, Obturator nerve blocks (Procedure, drug)
Dates	start 2018-02-09, primary completion 2024-12-18, completion 2024-12-18, first posted 2018-01-19, last updated 2026-01-08
Locations	1 site in United States

-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).

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+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.

+Arms and interventions

Arm	Type	Interventions	Description
Peripheral nerve block	Experimental	Procedure: Peripheral nerve block; Drug: Intravenous Sedatives; Procedure: Lateral femoral cutaneous nerve blocks; Procedure: Obturator nerve blocks	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.

Peripheral nerve block (Procedure): 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 Sedatives (Drug), also known as Propofol or Dexmedetomidine: Intravenous sedation using propofol or dexmedetomidine will be administered.
Lateral femoral cutaneous nerve blocks (Procedure): 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 blocks (Procedure): 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.

+Outcome measures

Primary outcomes

Peripheral Nerve Block Success as a Primary Anesthetic [Intraoperative period (typically one to three hours)]

Secondary outcomes

Mortality [Changes from baseline through 30 days post-operative.]: The medical record will be reviewed to assess 30-day mortality.

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Peripheral Nerve Block
Started	30
Completed	30
Not completed	0

Outcome results

Peripheral Nerve Block Success as a Primary Anesthetic (Primary), Count of participants, Participants: Peripheral Nerve Block 1
Mortality (Secondary), Count of participants, Participants: Peripheral Nerve Block 1

Adverse events

Time frame: Adverse events were monitored from informed consent until 30 days after surgery. Active adverse events assessments occurred at Day 30 post-enrollment (±7 days).

Arm	Deaths	Serious adverse events	Other adverse events
Peripheral Nerve Block	1/30 (3.3%)	0/30 (0.0%)	0/30 (0.0%)

+Locations (1)

Facility	City	Country	Status
University of Florida	Gainesville, Florida	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2025-03-26)
Informed Consent Form (PDF, 2019-10-29)

+Investigators

José R Soberón, MD, Principal investigator, Malcom Randall VA Medical Center

My Notes

Public

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