Peripheral Nerve Blocks for Above-the-knee Amputations

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).

Study Overview

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

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 Type: Interventional
• Enrollment (Estimated): 36
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Amy M. Gunnett, RN, CCRC; Phone Number: 352-273-8911; Email: agunnett@anest.ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32611
      • Recruiting
      • University of Florida

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

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; 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.; Drug: Intravenous Sedatives; Intravenous sedation using propofol or dexmedetomidine will be administered.; Other Names: Propofol or Dexmedetomidine; Procedure: 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.; Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Chi-squared tests of peripheral nerve block success as a primary anesthetic	Differences in block success percentages analyzed between study participants.	Changes from baseline through 30 days post-operative
Analysis of pain scores	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.	Changes from baseline through 48 hours post procedure.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	The medical record will be reviewed to assess 30-day mortality.	Changes from baseline through 30 days post-operative

Collaborators and Investigators

• Sponsor: University of Florida
• Collaborators: US Department of Veterans Affairs
• Investigators: Principal Investigator: José R Soberón, MD, Malcom Randall VA Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): February 9, 2018
• Primary Completion (Estimated): August 4, 2024
• Study Completion (Estimated): August 4, 2024

Study Registration Dates

• First Submitted: December 20, 2017
• First Submitted That Met QC Criteria: January 11, 2018
• First Posted (Actual): January 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 15, 2023
• Last Update Submitted That Met QC Criteria: September 14, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Respiratory Tract Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Lung Diseases; Disease Attributes; Atherosclerosis; Lung Diseases, Obstructive; Coronary Disease; Chronic Disease; Hyperglycemia; Coronary Artery Disease; Pulmonary Disease, Chronic Obstructive; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Propofol; Dexmedetomidine; Hypnotics and Sedatives
• Other Study ID Numbers: IRB201702402; OCR18952 (Other Identifier: University of Florida)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No