Trial Outcomes & Findings for Comparison of Nerve Stimulating Approach and Interfascial Injection Approach During Sono-guided Obturator Nerve Block (NCT NCT02452944)
NCT ID: NCT02452944
Last Updated: 2016-02-08
Results Overview
We used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients. In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a 'fail'.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
up to 8 weeks
Results posted on
2016-02-08
Participant Flow
dates of the recruitment period: January 2015 - May 2015 types of location: in the operating room
Participant milestones
| Measure |
US-IFI Group
ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis muscles. 10mL of local anesthetics (LA; 1.5% lidocaine + epi 1:200,000) were injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus muscles, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator for confirming the block. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.
|
US-NS Group
ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group)
The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics (LA;1.5% lidocaine + epi 1:200,000) were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
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|---|---|---|
|
Overall Study
STARTED
|
31
|
31
|
|
Overall Study
COMPLETED
|
31
|
31
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparison of Nerve Stimulating Approach and Interfascial Injection Approach During Sono-guided Obturator Nerve Block
Baseline characteristics by cohort
| Measure |
US-IFI Group
n=31 Participants
ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.
|
US-NS Group
n=31 Participants
ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at 0.3mA, 10mL of local anesthetics was injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and magnus. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
|
Total
n=62 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68 years
STANDARD_DEVIATION 14 • n=5 Participants
|
70 years
STANDARD_DEVIATION 11 • n=7 Participants
|
69.2 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Height (cm)
|
164.1 cm
STANDARD_DEVIATION 7.6 • n=5 Participants
|
166.3 cm
STANDARD_DEVIATION 6.3 • n=7 Participants
|
165.2 cm
STANDARD_DEVIATION 7.0 • n=5 Participants
|
|
Weight (kg)
|
61.9 kg
STANDARD_DEVIATION 11.3 • n=5 Participants
|
63.1 kg
STANDARD_DEVIATION 10.2 • n=7 Participants
|
62.5 kg
STANDARD_DEVIATION 10.7 • n=5 Participants
|
|
American Society of Anesthesiologists physical status (ASA)
ASA I
|
7 participants
n=5 Participants
|
11 participants
n=7 Participants
|
18 participants
n=5 Participants
|
|
American Society of Anesthesiologists physical status (ASA)
ASA II
|
24 participants
n=5 Participants
|
20 participants
n=7 Participants
|
44 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 8 weeksWe used only the nerve stimulator for confirming the success or fail of the ONB before the surgery, so we assumed that the US-NS group had complete ONB in all patients. In US-IFI group, complete ONB was confirmed with nerve stimulator at the end of the procedure, and if the residual twitching remained, the case was considered to be a 'fail'.
Outcome measures
| Measure |
US-IFI Group
n=31 Participants
ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerv
|
US-NS Group
n=31 Participants
ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided m
|
|---|---|---|
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Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group
fail
|
6 participants
|
0 participants
|
|
Success Rate of Ultrasound-guided Obturator Nerve Block With US-IFI Group and US-NS Group
success
|
25 participants
|
31 participants
|
SECONDARY outcome
Timeframe: up to 8 weeksWe checked the additional intramuscular twitching with at least 3 times more needling after block the anterior and posterior branches in both groups. And documented that twitching occurred in what kind of muscles.
Outcome measures
| Measure |
US-IFI Group
n=31 Participants
ultrasound-guided obturator nerve block with interfascial injection approach group (US-IFI; experimental group)
The stimulating needle without nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles, another 5mL of LA was injected.
After that, the needle was reinserted to the same spots attached with nerve stimulator at 1.0 mA. If adductor muscle twitching was shown, another 5mL of LA was injected, and it was documented as 'fail'.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided method for searching the fascias where the anterior and posterior branches of obturator nerv
|
US-NS Group
n=31 Participants
ultrasound-guided obturator nerve block with nerve stimulating approach group (US-NS; control group) The stimulating needle attached to a nerve stimulator advanced via an ultrasound to position the needle tip on the fascia between adductor longus and adductor brevis. The nerve stimulator was then turned on, and the stimulation current started at 0.5 mA. If adductor muscle twitching was observed on the sonogram even at the stimulation current 0.3mA, 10mL of local anesthetics were slowly injected. The needle was reinserted to position the needle tip on the fascia between adductor brevis and adductor magnus muscles. The stimulation current started at 0.5 mA. If adductor muscle twitching was visualized on the sonogram even at 0.3mA, another 5mL of LA was injected.
nerve stimulator (stimuplex HNS12): whether using the nerve stimulator or not when the investigators do the ultrasound-guided obturator nerve block
ultrasound: we did obturator nerve block with ultrasound guided m
|
|---|---|---|
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Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease
in the Adductor brevis muscle
|
8 participants
|
7 participants
|
|
Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease
In the adductor magnus muscle
|
0 participants
|
1 participants
|
|
Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease
In the Pectineus muscle
|
1 participants
|
2 participants
|
|
Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease
in the fascia of anterior branch run
|
2 participants
|
1 participants
|
|
Count the Number of Sub-divisions of Obturator Nerve at the Inguinal Crease
In the fascia of posterior branch run
|
2 participants
|
4 participants
|
Adverse Events
US-IFI Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
US-NS Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Mi Geum Lee
Department of Anesthesiology, Gachon University Gil Hospital
Phone: 82-32-460-3637
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place