Peripheral Nerve Blocks for Above-the-knee Amputations

Sponsor

University of Florida (Other)

Overall Status

Recruiting

CT.gov ID

NCT03404180

Collaborator

US Department of Veterans Affairs (U.S. Fed)

Enrollment

Location

Arm

53.7

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Peripheral Vascular Diseases Hyperglycaemia (Diabetic) Hypertension Coronary Artery Disease Pulmonary Disease, Chronic Obstructive	Procedure: Peripheral nerve block Drug: Intravenous Sedatives Procedure: Lateral femoral cutaneous nerve blocks Procedure: Obturator nerve blocks	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Pilot clinical trial with a single armPilot clinical trial with a single arm

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Peripheral Nerve Blocks for Upper Leg Amputations

Actual Study Start Date :

Feb 9, 2018

Anticipated Primary Completion Date :

Aug 1, 2022

Anticipated Study Completion Date :

Aug 1, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.