Peripheral Nerve Blocks for Above-the-knee Amputations

Hypertension Clinical Trial

Official title:

Peripheral Nerve Blocks for Upper Leg Amputations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03404180
• Other study ID #: IRB201702402
• Secondary ID: OCR18952
• Status: Recruiting
• Phase: Phase 4
• Start date: February 9, 2018
• Est. completion date: August 4, 2024

Study information

• Verified date: September 2023
• Source: University of Florida
• Contact: Amy M. Gunnett, RN, CCRC
• Phone: 352-273-8911
• Email: agunnett[@]anest.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 4, 2024
• Est. primary completion date: August 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.

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.
• 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.

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	US Department of Veterans Affairs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mortality	The medical record will be reviewed to assess 30-day mortality.	Changes from baseline through 30 days post-operative