Trial Outcomes & Findings for Comparing Ways to Freeze the Nerve That Provides Thigh Sensation (NCT NCT02577510)

NCT ID: NCT02577510

Last Updated: 2017-09-15

Results Overview

The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 21 participants
• Primary outcome timeframe: less than 30 minutes
• Results posted on: 2017-09-15

Participant Flow

We enrolled 21 participants and randomized the sides for each modality.

Unit of analysis: sides

Participant milestones

Measure	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. 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	Ultrasound Guided Xylocaine Injection 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 Study STARTED	21 21	21 21
Overall Study COMPLETED	21 21	21 21
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Comparing Ways to Freeze the Nerve That Provides Thigh Sensation

Baseline characteristics by cohort

Measure	All Participants n=21 Participants
Age, Continuous	40.3 years STANDARD_DEVIATION 10.1 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	17 Participants n=5 Participants
Region of Enrollment Canada	21 Participants n=5 Participants
BMI	26.7 kg/m^2 STANDARD_DEVIATION 3.5 • n=5 Participants

PRIMARY outcome

Timeframe: less than 30 minutes

The main outcome will be the total anesthesia-related time, defined as the sum of performance and onset times

Outcome measures

Measure	Nerve Stimulation n=21 sides	Ultrasound n=21 sides
Anesthesia Related Time	554 seconds Standard Deviation 366.9	480 seconds Standard Deviation 251.9

SECONDARY outcome

Timeframe: less than 30 minutes

percentage of patients with successful block

Outcome measures

Measure	Nerve Stimulation n=21 Participants	Ultrasound n=21 Participants
Success Rate	16 Participants	20 Participants

SECONDARY outcome

Timeframe: less than 30 minutes

how often needle changes angle to make target

Outcome measures

Measure	Nerve Stimulation n=21 sides	Ultrasound n=21 sides
Needle Pass	9.5 attempts Standard Deviation 12.2	3.2 attempts Standard Deviation 2.9

SECONDARY outcome

Timeframe: less than 30 minutes

visual analogue scale- 0-10 - 0 is equal to no pain, while 10 is equal to maximum pain

Outcome measures

Measure	Nerve Stimulation n=21 sides	Ultrasound n=21 sides
Pain With Procedure	4.0 units on a scale Standard Deviation 2.2	4.6 units on a scale Standard Deviation 2.2

Adverse Events

Ultrasound Guided Xylocaine Injection

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Nerve Stimulation Guided Xylocaine Injection

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Ultrasound Guided Xylocaine Injection n=21 participants at risk Adverse event collected for this side with this intervention.	Nerve Stimulation Guided Xylocaine Injection n=21 participants at risk Adverse event collected for this side with this intervention.
Nervous system disorders Femoral Block	4.8% 1/21 • Number of events 1 • within 30 minutes post injection and 72 hours of injection	0.00% 0/21 • within 30 minutes post injection and 72 hours of injection

Additional Information

Gaurav Gupta

CF

Phone: 6139451601

Email: gaurav00gupta@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place