Trial Outcomes & Findings for Peripheral Nerve Blocks for Above-the-knee Amputations (NCT NCT03404180)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE4

Target enrollment

30 participants

Primary outcome timeframe

Intraoperative period (typically one to three hours)

Results posted on

2026-01-08

Participant Flow

Participant milestones

Participant milestones
Measure	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 ultrasound-guided femoral and sciatic nerve 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: 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. Lateral 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. Obturator 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.
Overall Study STARTED	30
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Peripheral Nerve Block n=30 Participants Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered ultrasound-guided femoral and sciatic nerve 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: 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. Lateral 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. Obturator 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.
Age, Categorical <=18 years	0 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=30 Participants
Age, Categorical >=65 years	22 Participants n=30 Participants
Age, Continuous	69.9 years STANDARD_DEVIATION 8.7 • n=30 Participants
Sex: Female, Male Female	0 Participants n=30 Participants
Sex: Female, Male Male	30 Participants n=30 Participants
Region of Enrollment United States	30 Participants n=30 Participants

PRIMARY outcome

Timeframe: Intraoperative period (typically one to three hours)

Outcome measures

Outcome measures
Measure	Peripheral Nerve Block n=30 Participants Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered ultrasound-guided femoral and sciatic nerve 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: 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. Lateral 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. Obturator 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.
Peripheral Nerve Block Success as a Primary Anesthetic	1 Participants

SECONDARY outcome

Timeframe: Changes from baseline through 30 days post-operative.

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

Outcome measures

Outcome measures
Measure	Peripheral Nerve Block n=30 Participants Prospectively evaluate peripheral nerve blocks as a primary anesthetic in the setting of above-the-knee amputations. All enrollees will be administered ultrasound-guided femoral and sciatic nerve 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: 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. Lateral 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. Obturator 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.
Mortality	1 Participants

Adverse Events

Peripheral Nerve Block

Serious events: 0 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jose R. Soberon, Jr., MD

Malcom Randall VAMC/University of Florida

Phone: 352-376-1611

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place