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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Diagnostic
Condition Meralgia Paresthetica
Interventions Drug: Nerve Injection- Nerve Stimulator
Drug: Nerve Injection - Ultrasound
Enrollment 21
Recruitment Details  
Pre-assignment Details We enrolled 21 participants and randomized the sides for each modality.
Arm/Group Title Nerve Stimulation- Xylocaine Injection Ultrasound Guided Xylocaine Injection
Hide Arm/Group Description

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.

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

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 unt
Period Title: Overall Study
Number of participants Number of units (sides) Number of participants Number of units (sides)
Started 21 21 21 21
Completed 21 21 21 21
Not Completed 0 0 0 0
Arm/Group Title All Participants
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 21
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 21 participants
40.3  (10.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 21 participants
Female
4
  19.0%
Male
17
  81.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Canada Number Analyzed 21 participants
21
 100.0%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m^2
Number Analyzed 21 participants
26.7  (3.5)
1.Primary Outcome
Title Anesthesia Related Time
Hide Description The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times
Time Frame less than 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nerve Stimulation Ultrasound
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Sides
21 21
Mean (Standard Deviation)
Unit of Measure: seconds
554  (366.9) 480  (251.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Nerve Stimulation, Ultrasound
Comments Statistical analysis was performed using SPSS Version 21 statistical software (IBM, Armonk, New York). For continuous data, normality was fi rst assessed with the Lilliefors test and then analyzed using a paired t test. Data that did not have a normal distribution, as well as ordinal data, was analyzed using Wilcoxon’s signed ranks or McNemar’s test. All P values presented were 2-sided and values inferior to 0.05 were considered signifi cant
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.05
Comments [Not Specified]
Method t-test, 1 sided
Comments [Not Specified]
2.Secondary Outcome
Title Success Rate
Hide Description percentage of patients with successful block
Time Frame less than 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nerve Stimulation Ultrasound
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 21
Measure Type: Count of Participants
Unit of Measure: Participants
16
  76.2%
20
  95.2%
3.Secondary Outcome
Title Needle Pass
Hide Description how often needle changes angle to make target
Time Frame less than 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nerve Ultrasound
Hide Arm/Group Description:
[Not Specified]
[Not Specified]
Overall Number of Participants Analyzed 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Sides
21 21
Mean (Standard Deviation)
Unit of Measure: attempts
9.5  (12.2) 3.2  (2.9)
4.Secondary Outcome
Title Pain With Procedure
Hide Description visual analogue scale- 0-10 - 0 is equal to no pain, while 10 is equal to maximum pain
Time Frame less than 30 minutes
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Nerve Stimulation- Xylocaine Injection Ultrasound Guided Xylocaine Injection
Hide Arm/Group Description:

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.

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

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 unt
Overall Number of Participants Analyzed 21 21
Overall Number of Units Analyzed
Type of Units Analyzed: Sides
21 21
Mean (Standard Deviation)
Unit of Measure: units on a scale
4.0  (2.2) 4.6  (2.2)
Time Frame within 30 minutes post injection and 72 hours of injection
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Ultrasound Guided Xylocaine Injection Nerve Stimulation Guided Xylocaine Injection
Hide Arm/Group Description Adverse event collected for this side with this intervention. Adverse event collected for this side with this intervention.
All-Cause Mortality
Ultrasound Guided Xylocaine Injection Nerve Stimulation Guided Xylocaine Injection
Affected / at Risk (%) Affected / at Risk (%)
Total   0/21 (0.00%)      0/21 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Ultrasound Guided Xylocaine Injection Nerve Stimulation Guided Xylocaine Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/21 (0.00%)      0/21 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Ultrasound Guided Xylocaine Injection Nerve Stimulation Guided Xylocaine Injection
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/21 (4.76%)      0/21 (0.00%)    
Nervous system disorders     
Femoral Block  [1]  1/21 (4.76%)  1 0/21 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
femoral nerve block
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gaurav Gupta
Organization: CF
Phone: 6139451601
EMail: gaurav00gupta@gmail.com
Publications:
Layout table for additonal information
Responsible Party: Gaurav Gupta, Canadian Forces Health Services Centre Ottawa
ClinicalTrials.gov Identifier: NCT02577510     History of Changes
Other Study ID Numbers: #2014-005-
First Submitted: October 14, 2015
First Posted: October 16, 2015
Results First Submitted: July 18, 2017
Results First Posted: September 15, 2017
Last Update Posted: September 15, 2017