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Trial record 15 of 119 for:    "Neuromuscular Disease" | "Lidocaine"

Comparing Ways to Freeze the Nerve That Provides Thigh Sensation

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ClinicalTrials.gov Identifier: NCT02577510
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : September 15, 2017
Last Update Posted : September 15, 2017
Sponsor:
Information provided by (Responsible Party):
Gaurav Gupta, Canadian Forces Health Services Centre Ottawa

Brief Summary:

Background

The sensation on the outside of portion of our thighs is provided by a nerve called the lateral femoral cutaneous nerve (LFCN). The investigators can inject freezing around the nerve to reduce the feeling around the thigh (i.e. anesthesia). Anesthesia, or freezing, of the lateral femoral cutaneous nerve can reduce pain for patients having A) hip and knee surgery [1,2], B) removal of a skin graft [3], and C) wound care. In addition, damage to the LFCN (i.e. Meralgia Paresthetica) has been associated with body armour and gun belt use in military and police personnel [4]. Although generally a benign condition, compression or injury to this nerve can be painful and require treatment. In addition, the actual variability in sensory distribution for this nerve has not been elucidated in a topographical fashion and will be measured in this study.

Finding the most efficient and effective method for anesthesia of the LFCN can improve and positively impact the quality of pain control for patients. Ultrasound has improved the accuracy and efficiency of various other regional anesthesia techniques, and could also impact the safety. Therefore the investigators hypothesize that ultrasound guided lateral femoral cutaneous nerve block using the subinguinal technique will be statistically more efficacious and efficient when compare to neurostimulation based blockade.


Condition or disease Intervention/treatment Phase
Meralgia Paresthetica Drug: Nerve Injection- Nerve Stimulator Drug: Nerve Injection - Ultrasound Phase 3

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: A Comparison Between Ultrasound- and Neurostimulation-Guided Lateral Femoral Cutaneous Nerve Block
Study Start Date : November 2015
Actual Primary Completion Date : February 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Nerve Stimulation- Xylocaine injection
Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique.
Drug: Nerve Injection- Nerve Stimulator
For the neurostimulation nerve injection technique, the initial puncture site will be located medial to the anterosuperior iliac spine, just caudal to the inguinal ligament [7]. The 22-gauge insulated needle will be connected to a stimulator set at a current of 1.5 mA, a pulse width of 300 ms and a frequency of 2 Hz. A paresthesia referred to the lateral aspect of the thigh at a minimal stimulatory threshold of 0.6 mA (0.3ms) will be sought prior to the injection of local anesthetic [7]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia.
Other Name: Lateral Femoral Cutaneous Nerve Block- Neurostimulation

Experimental: Ultrasound guided Xylocaine injection
Anesthesia of the lateral femoral cutaneous nerve using local anesthetic will be randomly assigned on the right or left side to receive nerve stimulation-xylocaine or ultrasound guided -xylocaine injections in all patients. One patient will therefore have both nerve stimulation AND ultrasound guided injections, only the side of the injection will be randomly assigned to one of the two modalities. Once one technique has been used to freeze one side, the other side will be frozen using the other technique.
Drug: Nerve Injection - Ultrasound
For the ultrasound nerve injection group, after skin disinfection, the inguinal region of patients will be scanned using a high-frequency (6 to 13 MHz) linear array transducer covered with a sterile plastic cover. An ultrasound image showing the inguinal ligament and anterior superior iliac spine (ASIS) will be obtained. Using an out-of-plane technique, a 22-gauge nerve block needle will be inserted 1-2 cm medial to ASIS. The needle will be advanced until its tip rests under the inguinal ligament, immediately ventral to the iliopsoas muscle [6]. A total of 5cc of 2%Xylocaine will be injected for the nerve injection/anesthesia.
Other Name: Lateral Femoral Cutaneous Nerve Block- Ultrasound




Primary Outcome Measures :
  1. Anesthesia Related Time [ Time Frame: less than 30 minutes ]
    The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times


Secondary Outcome Measures :
  1. Success Rate [ Time Frame: less than 30 minutes ]
    percentage of patients with successful block

  2. Needle Pass [ Time Frame: less than 30 minutes ]
    how often needle changes angle to make target

  3. Pain With Procedure [ Time Frame: less than 30 minutes ]
    visual analogue scale- 0-10 - 0 is equal to no pain, while 10 is equal to maximum pain



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • male and female between 18 and 60 years old
  • American Society of Anesthesiologists classification 1-3

Exclusion Criteria:

  • adults who are unable to give their own consent
  • pre-existing neuropathy (assessed by history and physical examination) -
  • coagulopathy (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. platelets ≤ 100, International Normalized Ratio ≥ 1.4 or prothrombin time ≥ 50)
  • renal failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. creatinine ≥ 100)
  • hepatic failure (assessed by history and physical examination and, if deemed clinically necessary, by blood work up i.e. transaminases ≥ 100)
  • allergy to local anesthetic agents local anesthetic
  • pregnancy based on patient self report of last menstrual cycle. If a patient wish/insist on participating in the study, and pregnancy status is unclear, a urine pregnancy test will be offered. Also risk of Lidocaine in pregnancy will be discussed with the patient as currently classified. We will convey that this risk is currently classified as a Risk Class B, which means that animal-reproduction studies have not demonstrated a fetal risk but there are no controlled studies in pregnant women. We will also discuss that animal-reproduction studies have shown an decrease in maternal fertility), but that was not confirmed in controlled studies in women in the first trimester and there is no evidence of a risk in later trimesters,
  • prior surgery in the hip and lateral leg region
  • prior lumbar surgery
  • previous pelvic fracture
  • previous L1, L2 or L3 lumbar radiculopathy, plexopathy or meralgia paresthetica
  • chronic pain syndromes requiring opioid intake

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577510


Sponsors and Collaborators
Canadian Forces Health Services Centre Ottawa
Investigators
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Principal Investigator: Gaurav Gupta, MD CF Health Centre Ottawa

Publications:

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Responsible Party: Gaurav Gupta, MD FRCPC, Canadian Forces Health Services Centre Ottawa
ClinicalTrials.gov Identifier: NCT02577510     History of Changes
Other Study ID Numbers: #2014-005-
First Posted: October 16, 2015    Key Record Dates
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Gaurav Gupta, Canadian Forces Health Services Centre Ottawa:
Lateral Femoral Cutaneous Nerve Block
Meralgia Parasthetica
nerve stimulator
ultrasound
Additional relevant MeSH terms:
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Neuromuscular Diseases
Lidocaine
Femoral Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Nervous System Diseases
Anesthetics
Anesthetics, Local
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action