Peripheral Nerve Blocks for Above-the-knee Amputations

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-02-09

Study Completion Date

2024-12-18

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Pilot clinical trial with a single arm

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Peripheral nerve block

Intervention Type PROCEDURE

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.

Intravenous Sedatives

Intervention Type DRUG

Intravenous sedation using propofol or dexmedetomidine will be administered.

Lateral femoral cutaneous nerve blocks

Intervention Type PROCEDURE

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

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Intravenous Sedatives

Intravenous sedation using propofol or dexmedetomidine will be administered.

Intervention Type DRUG

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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Propofol or Dexmedetomidine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No