Ultrasound for Neuraxial Anesthesia

Study Overview
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Brief Summary
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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.

Official Title
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Study of the Use of Ultrasound Scan for Lumbar Regional Anesthesia

Conditions
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Lumbar Ultrasound

Intervention / Treatment
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* Device: Detection of the puncture site by ultrasound scan of the lumbar spine.
* Procedure: Detection of the puncture site by identification of the landmarks.


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br> | Device: Detection of the puncture site by ultrasound scan of the lumbar spine.<br>* 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.<br>|
| Active Comparator: Landmarks<br> | Procedure: Detection of the puncture site by identification of the landmarks.<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | An expected average of 10 minutes after the technique. | 
| 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. | An expected average of 10 minutes after the technique. | 
| Number of Attempts Required. | How many times did the operator withdraw the needle and repeated the puncture. | An expected average of 10 minutes after the technique.. | 
| Repositioning Frequency. | How many times did the operator change the trajectory of the needle. | An expected average of 10 minutes after the technique. | 
| 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. | An expected average of 10 minutes after the technique. | 
| Time Required. | Time passed from the positioning of the patient on the table until the end of the neuraxial anesthesia | An expected average of 15 minutes. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Depth of the Epidural Space Measured by Ultrasound. | The distance between the skin and the ligamentum flavum measured by the built-in ultrasound caliper. | An expected average of 3 minutes after the beginning of the procedure. | 
| 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. | An expected average of 5 minutes after the beginning of the procedure. | 
| Number of Patients With Low Back Pain. | Number of patients who reported low back pain after the technique. | 12hours and 24hours after the end of the technique. | 
| 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). | 12hours and 24hours after the end of the technique. | 
| 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). | 12hours after the end of the technique. | 
| Number of Participants With Any Complication. | Number of patients who had any complication after the technique | 24hours after the end of the technique. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ultrasound, Spinal anesthesia, Epidural anesthesia