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Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section

Not Applicable
Conditions
Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
Interventions
Other: leg elevation
Registration Number
NCT03488277
Lead Sponsor
Mongi Slim Hospital
Brief Summary

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

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

Recruitment & Eligibility

Status
UNKNOWN
Sex
Female
Target Recruitment
200
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SEQUENTIAL
Arm && Interventions
GroupInterventionDescription
LE: leg elevation groupleg elevationthe 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
Primary Outcome Measures
NameTimeMethod
Incidence of post spinal hypotensionduring the first 30minutes after the spinal anesthesia

change of systolic blood pressure from baseline\< 90 mmHg

Secondary Outcome Measures
NameTimeMethod
Lowest systolic blood pressureduring the first 30 minutes following spinal anesthesia

the lowest systolic blood pressure observed after spinal anesthesia

ephedrine consumptionduring the first 30 minutes following the spinal anesthesia

total dose of Ephedrine received to treat post spinal hypotension

Fetal ph30 minutes after spinal anesthesia

fetal ph measured with blood gas analysis

Fetal blood lactates30 minutes after spinal anesthesia

fetal blood lactates (mmol/L) measured with blood gas analysis

Trial Locations

Locations (1)

Mongi Slim Hospital

🇹🇳

La Marsa, Tunis, Tunisia

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