Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section

Study Overview
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Brief Summary
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Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups: LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction. Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil.

Detailed Description
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Prospective trial including full term parturients scheduled for a cesarean section under spinal anesthesia. patients are being randomly assigned into 2 groups: LE group: will be positioned in 15° left tilt with leg elevation with a 30cm height pillow under the heels, this position will be hold after spinal anesthesia until fetal extraction. Control group: will be positioned in supine with 15° left tilt. the 2 groups will receive a 10ml/kg of crystalloid co-load intravenously, and the spinal anesthesia will be performed in sitting position with the same dose of Bupivacain, morphine and sufentanil. we will record the demographic data, pre and intraoperative hemodynamic parameters, the dose of ephedrine required to treat post spinal hypotension and fetal parameters: pH and blood lactates

Official Title
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Evaluation of the Efficiency of Leg Elevation for Preventing Post Spinal Hypotension in Cesarean Section

Conditions
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Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Intervention / Treatment
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* Other: leg elevation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: full term parturients age> 18 Y scheduled of elective or urgent cesarean section under spinal anesthesia Exclusion Criteria: patients who had general anesthesia

Ages Eligible for Study
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Minimum Age: 18 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: Prevention
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LE: leg elevation group<br>the patients of this group will be positionned in supine with 15° left tilt and will have a leg elevation with a 30 cm pillow positionned under the heels. this position will be hold immediately after spinal anesthesia until fetal extraction | Other: leg elevation<br>* intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels<br>|
| No Intervention: CG: Control group<br>The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of post spinal hypotension | change of systolic blood pressure from baseline< 90 mmHg | during the first 30minutes after the spinal anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest systolic blood pressure | the lowest systolic blood pressure observed after spinal anesthesia | during the first 30 minutes following spinal anesthesia | 
| ephedrine consumption | total dose of Ephedrine received to treat post spinal hypotension | during the first 30 minutes following the spinal anesthesia | 
| Fetal ph | fetal ph measured with blood gas analysis | 30 minutes after spinal anesthesia | 
| Fetal blood lactates | fetal blood lactates (mmol/L) measured with blood gas analysis | 30 minutes after spinal anesthesia |