Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia

Study Overview
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Brief Summary
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Pre-procedural ultrasound for Spinal & Epidural anesthesia is now being increasingly performed worldwide. Pre-procedural ultrasound assessment of the spine has been shown to facilitate the placement of epidural anesthesia in pregnant women, diagnostic lumbar punctures, performance of spinal anesthesia in non-obstetric patients and accurate identification of the interspace at which the puncture is being performed. This is especially important during spinal anesthesia, where puncture below the ending of the spinal cord is recommended for safety. The purpose of this study is to compare the performance of spinal anesthesia between the pre-procedural ultrasound assessment of the spine and the traditional palpatory technique, in term pregnant women undergoing elective cesarean delivery. Furthermore, we aim to describe sonoanatomic features of the spine that could predict the ease of insertion of spinal anesthesia in that patient population. We hypothesize that in term pregnant women undergoing elective cesarean delivery, pre-procedural ultrasound assessment of the spine will improve the success rate of spinal anesthesia at first attempt, compared to the traditional palpatory technique.

Official Title
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Comparison Between Palpatory and Preprocedural Ultrasound Guided Techniques on Performance of Spinal Anesthesia in Term Parturients Undergoing Elective Caesarian Section- A Randomized Control Trial

Conditions
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Pregnancy

Intervention / Treatment
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* Procedure: Ultrasound
* Device: The spinal needle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant patients scheduled to receive spinal anesthesia for elective cesarean sections ASA physical status 1 - 3 Written informed consent Gestational age ≥ 37 weeks. Exclusion Criteria: Patient's refusal. Body mass index ≥ 45 Patient with marked spinal bony deformity (Severe scoliosis on visual inspection and previous spinal instrumentation).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Palpation<br>Palpation will be used to determine placement of the spinal needle. | |
| Experimental: Ultrasound<br>Ultrasound will be used prior to placement of the spinal needle. | Procedure: Ultrasound<br>* Ultrasound applied to the lumbar region to determine spinal needle placement.<br>Device: The spinal needle<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal needle redirections | Number of redirections needed to perform a successful spinal puncture (presence of cerebrospinal fluid). A needle redirection is defined as any change in needle insertion trajectory that did not involve complete withdrawal of the needle from the patient's skin. The first needle pass will not be considered a redirection. | 15 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Needle reinsertions | Number of needle reinsertions defined as complete withdrawal of the spinal needle to the patient's skin followed by a new attempt in the same interspace. | 15 minutes | 
| Need to change to another interspace. | Relocating the spinal needle to another interspace. | 15 minutes | 
| Procedure time | Time taken to perform the spinal anesthesia, measured from insertion of the introducer needle to visualization of spinal fluid. | 15 minutes | 
| Pain score | Verbal Numerical Pain Scores during the procedure (0-10, where 0 means no pain and 10 mean the worst pain imaginable). | 15 minutes | 
| Intervertebral level agreement | Intervertebral level agreement between L3-L4 obtained in the postoperative ultrasound assessment and the marked intervertebral level obtained pre-procedure, either by ultrasound or palpation. | 3 hours | 
| Ultrasound Grading | Ultrasound Grading: The image pattern of the intervertebral space will be categorized into three grades by three study investigators not involved in providing the spinal anesthesia: Typical Image,Atypical Image or Inconclusive Image. | 3 hours | 

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