Peripheral Nerve Blocks for Above-the-knee Amputations

Phase 4

Recruiting

• Conditions: Peripheral Vascular Diseases; Hypertension; Hyperglycaemia (Diabetic); Coronary Artery Disease; Pulmonary Disease, Chronic Obstructive
• Interventions: Procedure: Peripheral nerve block; Drug: Intravenous Sedatives; Procedure: Lateral femoral cutaneous nerve blocks; Procedure: Obturator nerve blocks

• Registration Number: NCT03404180
• Lead Sponsor: University of Florida

Brief 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).

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2017-12-20
• Study First Submitted QC: 2018-01-11
• Study First Posted: 2018-01-19
• Study Start: 2018-02-09
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-22
• Last Update Posted: 2024-08-26
• Primary Completion: 2025-08-04
• Study Completion: 2025-08-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Peripheral nerve block	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.
Peripheral nerve block	Intravenous Sedatives	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	Lateral femoral cutaneous 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	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.

Primary Outcome Measures

Name	Time	Method
Chi-squared tests of peripheral nerve block success as a primary anesthetic	Changes from baseline through 30 days post-operative	Differences in block success percentages analyzed between study participants.
Analysis of pain scores	Changes from baseline through 48 hours post procedure.	Numerical rating scale pain scores (0-10) will be obtained from patients upon arrival and recorded hourly until discharge. Patients will be called or visited 24-48 hours post procedure to inquire about patient satisfaction. Differences in study participant pain scores will be examined through t-tests. P \< 0.05 will be considered statistically significant.

Secondary Outcome Measures

Name	Time	Method
Mortality	Changes from baseline through 30 days post-operative	The medical record will be reviewed to assess 30-day mortality.

Trial Locations

Locations (1)

University of Florida; 🇺🇸 Gainesville, Florida, United States