Trial Outcomes & Findings for Ultrasound for Neuraxial Anesthesia (NCT NCT02553746)
NCT ID: NCT02553746
Last Updated: 2019-08-12
Results Overview
For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
146 participants
Primary outcome timeframe
An expected average of 10 minutes after the technique.
Results posted on
2019-08-12
Participant Flow
Participant milestones
| Measure |
Ultrasound
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
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Landmarks
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Overall Study
STARTED
|
80
|
66
|
|
Overall Study
COMPLETED
|
77
|
64
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Ultrasound for Neuraxial Anesthesia
Baseline characteristics by cohort
| Measure |
Ultrasound
n=80 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=66 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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Total
n=146 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
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52.42 years
STANDARD_DEVIATION 18.948 • n=5 Participants
|
56.32 years
STANDARD_DEVIATION 19,961 • n=7 Participants
|
54.24 years
STANDARD_DEVIATION 19.387 • n=5 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
41 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
80 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Greece
|
80 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
BMI
|
27.764 kg/m^2
STANDARD_DEVIATION 3.784 • n=5 Participants
|
28.427 kg/m^2
STANDARD_DEVIATION 5.158 • n=7 Participants
|
28.12 kg/m^2
STANDARD_DEVIATION 4.5 • n=5 Participants
|
|
Type of anaesthesia
Spinal anaesthesia
|
45 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
|
Type of anaesthesia
Epidural anaesthesia
|
9 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Type of anaesthesia
Combined spinal-epidural anaesthesia
|
26 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: An expected average of 10 minutes after the technique.For spinal and epidural anesthesia, success of the technique is defined as the installation of sensory block before surgery. For epidural catheter placement success of the technique is defined as the installation of sensory block after the end of surgery.
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Number of Participants With Successful Techniques
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74 Participants
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63 Participants
|
PRIMARY outcome
Timeframe: An expected average of 10 minutes after the technique.Number of patients with completion of the technique without any withdrawal or reposition of the needle.
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Number of Participants With Success of the Technique at the First Attempt
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48 Participants
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35 Participants
|
PRIMARY outcome
Timeframe: An expected average of 10 minutes after the technique..How many times did the operator withdraw the needle and repeated the puncture.
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Number of Attempts Required.
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1.65 number of attempts
Standard Deviation 0.978
|
2.06 number of attempts
Standard Deviation 1.413
|
PRIMARY outcome
Timeframe: An expected average of 10 minutes after the technique.How many times did the operator change the trajectory of the needle.
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Repositioning Frequency.
|
0.74 repositioning attempts
Standard Deviation 0.973
|
1.14 repositioning attempts
Standard Deviation 1.357
|
PRIMARY outcome
Timeframe: An expected average of 10 minutes after the technique.Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Number of Participants With Change of the Intervertebral Space.
|
14 Participants
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20 Participants
|
PRIMARY outcome
Timeframe: An expected average of 15 minutes.Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Time Required.
|
550.46 seconds
Standard Deviation 214.016
|
451.94 seconds
Standard Deviation 291.473
|
SECONDARY outcome
Timeframe: An expected average of 3 minutes after the beginning of the procedure.Population: Data not collected
The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: An expected average of 5 minutes after the beginning of the procedure.The distance between the skin and the ligamentum flavum measured by the markers on the Tuohy needle.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12hours and 24hours after the end of the technique.Number of patients who reported low back pain after the technique.
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Number of Patients With Low Back Pain.
|
11 Participants
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11 Participants
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SECONDARY outcome
Timeframe: 12hours and 24hours after the end of the technique.Population: Data not collected
The patient is asked to evaluate the lumbar pain by the 11scale Numerical Rating Scale (0 no pain, 10 maximum possible pain).
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12hours after the end of the technique.The patient is asked if he is satisfied with the technique (Definitely not, Not completely, Yes) and if he would choose the same technique in the future (Yes/No).
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
|
Patient Satisfaction.
Yes
|
74 Participants
|
63 Participants
|
|
Patient Satisfaction.
Not exactly
|
3 Participants
|
1 Participants
|
|
Patient Satisfaction.
No
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 24hours after the end of the technique.Number of patients who had any complication after the technique
Outcome measures
| Measure |
Ultrasound
n=77 Participants
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=64 Participants
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
|
Number of Participants With Any Complication.
|
0 Participants
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0 Participants
|
Adverse Events
Ultrasound
Serious events: 0 serious events
Other events: 80 other events
Deaths: 0 deaths
Landmarks
Serious events: 0 serious events
Other events: 66 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Ultrasound
n=80 participants at risk
Detection of the puncture site by ultrasound scan of the lumbar spine.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by ultrasound scan of the spine. The L3-L4 space will be identified by palpation and identification of the Tuffier's line. The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified. The probe will be moved to cephalad or caudal to identify the intervertebral space and when the best view of the ligamentum flavum is achieved two marks will be drawn on the skin: one at the center of the upper surface of the probe and one at the center of the right lateral vertical side of the probe. The intersection of the two landmarks will be the puncture site.
|
Landmarks
n=66 participants at risk
Detection of the puncture site by identification of the landmarks.: Neuraxial anesthesia will be performed to the patients after detection of the puncture site by the identification of the landmarks. The L3-L4 space will be identified by palpation of the posterior iliac crests and the ideal intervertebral space will be selected after palpation of the spinous processes.
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|---|---|---|
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Skin and subcutaneous tissue disorders
Skin irritation
|
100.0%
80/80 • Within 24 hours after the completion of the technique
The intervention of the study consists of ultrasound imaging which doesn't carry any risk for serious adverse events nor it can potentially affect all-cause mortality
|
100.0%
66/66 • Within 24 hours after the completion of the technique
The intervention of the study consists of ultrasound imaging which doesn't carry any risk for serious adverse events nor it can potentially affect all-cause mortality
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place