Lumbar Ultrasound
Conditions
Keywords
Ultrasound, Spinal anesthesia, Epidural anesthesia
Brief summary
The patients will be allocated to 2 groups: the ultrasound group and the palpation group. Ultrasound detection of the puncture site will be performed to the patients of the one group (group U). The puncture site will be determined by palpation of the landmarks at the patients of the other group (group L). The main purpose of the study is to determine if the ultrasound scan of the lumbar spine can facilitate spinal, epidural and combined spinal-epidural anesthesia, increase the success and decrease the complication rate of these techniques. The secondary purpose of the study is to evaluate if the lumbar ultrasound scan can be used to determine accurately the depth of the epidural space.
Interventions
DEVICEDetection 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 scanning will be performed as described by Arzola et al. The L3-L4 space will be identified by palpation and identification of the landmarks (Tuffier's line). The ultrasound probe will be placed perpendicular to the long axis of the spine. The spinous process will be identified (bright signal followed by dark triangular area). 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. The distance from the skin to the ligamentum flavum will be measured by the ultrasound caliper.
PROCEDUREDetection 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.
Sponsors
424 General Military Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Surgery under spinal, epidural or combined spinal-epidural anesthesia. * Surgery under general anesthesia and preoperative placement of epidural catheter for postoperative analgesia. * ASA 1-3.
Exclusion criteria
* History of lumbar spinal surgery. * Low back pain at the time of anesthesia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time Required. | An expected average of 15 minutes. | Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia |
| Number of Participants With Successful Techniques | 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. |
| Number of Participants With Success of the Technique at the First Attempt | 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. |
| Number of Attempts Required. | An expected average of 10 minutes after the technique.. | How many times did the operator withdraw the needle and repeated the puncture. |
| Repositioning Frequency. | An expected average of 10 minutes after the technique. | How many times did the operator change the trajectory of the needle. |
| Number of Participants With Change of the Intervertebral Space. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depth of the Epidural Space Measured by Ultrasound. | An expected average of 3 minutes after the beginning of the procedure. | The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper. |
| Depth of the Epidural Space Measured by the Needle. | 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. |
| Number of Patients With Low Back Pain. | 12hours and 24hours after the end of the technique. | Number of patients who reported low back pain after the technique. |
| Low Back Pain Intensity. | 12hours and 24hours after the end of the technique. | The patient is asked to evaluate the lumbar pain by the 11scale Numerical Rating Scale (0 no pain, 10 maximum possible pain). |
| Patient Satisfaction. | 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). |
| Number of Participants With Any Complication. | 24hours after the end of the technique. | Number of patients who had any complication after the technique |
Countries
Greece
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 80 |
| 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. | 66 |
| Total | 146 |
Baseline characteristics
| Characteristic | Ultrasound | Landmarks | Total |
|---|---|---|---|
| Age, Continuous | 52.42 years STANDARD_DEVIATION 18.948 | 56.32 years | 54.24 years STANDARD_DEVIATION 19.387 |
| BMI | 27.764 kg/m^2 STANDARD_DEVIATION 3.784 | 28.427 kg/m^2 STANDARD_DEVIATION 5.158 | 28.12 kg/m^2 STANDARD_DEVIATION 4.5 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 80 Participants | 66 Participants | 146 Participants |
| Region of Enrollment Greece | 80 Participants | 66 Participants | 146 Participants |
| Sex: Female, Male Female | 23 Participants | 25 Participants | 48 Participants |
| Sex: Female, Male Male | 57 Participants | 41 Participants | 98 Participants |
| Type of anaesthesia Combined spinal-epidural anaesthesia | 26 Participants | 16 Participants | 42 Participants |
| Type of anaesthesia Epidural anaesthesia | 9 Participants | 7 Participants | 16 Participants |
| Type of anaesthesia Spinal anaesthesia | 45 Participants | 43 Participants | 88 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 80 | 0 / 66 |
| other Total, other adverse events | 80 / 80 | 66 / 66 |
| serious Total, serious adverse events | 0 / 80 | 0 / 66 |
Outcome results
Primary
Number of Attempts Required.
How many times did the operator withdraw the needle and repeated the puncture.
Time frame: An expected average of 10 minutes after the technique..
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound | Number of Attempts Required. | 1.65 number of attempts | Standard Deviation 0.978 |
| Landmarks | Number of Attempts Required. | 2.06 number of attempts | Standard Deviation 1.413 |
p-value: 0.171Wilcoxon (Mann-Whitney)
Primary
Number of Participants With Change of the Intervertebral Space.
Number of patients to whom the operator had to perform the puncture at a different intervertebral place than the initial one.
Time frame: An expected average of 10 minutes after the technique.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound | Number of Participants With Change of the Intervertebral Space. | 14 Participants |
| Landmarks | Number of Participants With Change of the Intervertebral Space. | 20 Participants |
p-value: 0.104Chi-squared, Corrected
Primary
Number of Participants With Successful Techniques
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.
Time frame: An expected average of 10 minutes after the technique.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound | Number of Participants With Successful Techniques | 74 Participants |
| Landmarks | Number of Participants With Successful Techniques | 63 Participants |
p-value: 0.748Chi-squared, Corrected
Primary
Number of Participants With Success of the Technique at the First Attempt
Number of patients with completion of the technique without any withdrawal or reposition of the needle.
Time frame: An expected average of 10 minutes after the technique.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound | Number of Participants With Success of the Technique at the First Attempt | 48 Participants |
| Landmarks | Number of Participants With Success of the Technique at the First Attempt | 35 Participants |
p-value: 0.498Chi-squared, Corrected
Primary
Repositioning Frequency.
How many times did the operator change the trajectory of the needle.
Time frame: An expected average of 10 minutes after the technique.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound | Repositioning Frequency. | 0.74 repositioning attempts | Standard Deviation 0.973 |
| Landmarks | Repositioning Frequency. | 1.14 repositioning attempts | Standard Deviation 1.357 |
p-value: 0.162Wilcoxon (Mann-Whitney)
Primary
Time Required.
Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia
Time frame: An expected average of 15 minutes.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ultrasound | Time Required. | 550.46 seconds | Standard Deviation 214.016 |
| Landmarks | Time Required. | 451.94 seconds | Standard Deviation 291.473 |
p-value: <0.005Wilcoxon (Mann-Whitney)
Secondary
Depth of the Epidural Space Measured by the Needle.
The distance between the skin and the ligamentum flavum measured by the markers on the Tuohy needle.
Time frame: An expected average of 5 minutes after the beginning of the procedure.
Secondary
Depth of the Epidural Space Measured by Ultrasound.
The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper.
Time frame: An expected average of 3 minutes after the beginning of the procedure.
Population: Data not collected
Secondary
Low Back Pain Intensity.
The patient is asked to evaluate the lumbar pain by the 11scale Numerical Rating Scale (0 no pain, 10 maximum possible pain).
Time frame: 12hours and 24hours after the end of the technique.
Population: Data not collected
Secondary
Number of Participants With Any Complication.
Number of patients who had any complication after the technique
Time frame: 24hours after the end of the technique.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound | Number of Participants With Any Complication. | 0 Participants |
| Landmarks | Number of Participants With Any Complication. | 0 Participants |
Secondary
Number of Patients With Low Back Pain.
Number of patients who reported low back pain after the technique.
Time frame: 12hours and 24hours after the end of the technique.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ultrasound | Number of Patients With Low Back Pain. | 11 Participants |
| Landmarks | Number of Patients With Low Back Pain. | 11 Participants |
Secondary
Patient Satisfaction.
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).
Time frame: 12hours after the end of the technique.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Ultrasound | Patient Satisfaction. | Not exactly | 3 Participants |
| Ultrasound | Patient Satisfaction. | Yes | 74 Participants |
| Ultrasound | Patient Satisfaction. | No | 0 Participants |
| Landmarks | Patient Satisfaction. | Yes | 63 Participants |
| Landmarks | Patient Satisfaction. | Not exactly | 1 Participants |
| Landmarks | Patient Satisfaction. | No | 0 Participants |