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Peripheral Nerve Blocks for Above-the-knee Amputations

Primary Purpose

Peripheral Vascular Diseases, Hyperglycaemia (Diabetic), Hypertension

Status

Recruiting

Phase

Phase 4

Locations

United States

Study Type

Interventional

Intervention

Peripheral nerve block

Intravenous Sedatives

Lateral femoral cutaneous nerve blocks

Obturator nerve blocks

About this trial

This is an interventional basic science trial for Peripheral Vascular Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of FloridaRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Peripheral nerve block

Arm Description

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.

Outcomes

Primary Outcome Measures

Chi-squared tests of peripheral nerve block success as a primary anesthetic

Differences in block success percentages analyzed between study participants.

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.

Secondary Outcome Measures

Mortality

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

Full Information

NCT ID

NCT03404180

First Posted

December 20, 2017

Last Updated

September 14, 2023

Sponsor

University of Florida

Collaborators

US Department of Veterans Affairs

1. Study Identification

Unique Protocol Identification Number

NCT03404180

Brief Title

Peripheral Nerve Blocks for Above-the-knee Amputations

Official Title

Peripheral Nerve Blocks for Upper Leg Amputations

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 9, 2018 (Actual)

Primary Completion Date

August 4, 2024 (Anticipated)

Study Completion Date

August 4, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Florida

Collaborators

US Department of Veterans Affairs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Model Description

Pilot clinical trial with a single arm

Masking

None (Open Label)

Allocation

N/A

Enrollment

36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Peripheral nerve block

Arm Type

Experimental

Arm Description

Intervention Type

Procedure

Intervention Name(s)

Peripheral nerve block

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Intravenous Sedatives

Other Intervention Name(s)

Propofol or Dexmedetomidine

Intervention Description

Intravenous sedation using propofol or dexmedetomidine will be administered.

Intervention Type

Procedure

Intervention Name(s)

Lateral femoral cutaneous nerve blocks

Intervention Description

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.

Intervention Type

Procedure

Intervention Name(s)

Obturator nerve blocks

Intervention Description

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.

Primary Outcome Measure Information:

Title

Chi-squared tests of peripheral nerve block success as a primary anesthetic

Description

Differences in block success percentages analyzed between study participants.

Time Frame

Changes from baseline through 30 days post-operative

Title

Analysis of pain scores

Description

Time Frame

Changes from baseline through 48 hours post procedure.

Secondary Outcome Measure Information:

Title

Mortality

Description

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

Time Frame

Changes from baseline through 30 days post-operative

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amy M. Gunnett, RN, CCRC

Phone

352-273-8911

agunnett@anest.ufl.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

José R Soberón, MD

Organizational Affiliation

Malcom Randall VA Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Florida

City

Gainesville

State/Province

Florida

ZIP/Postal Code

32611

Country

United States

Individual Site Status

Recruiting

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Peripheral Nerve Blocks for Above-the-knee Amputations

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