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Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section

M

Mongi Slim Hospital

Status

Unknown

Conditions

Effects of; Anesthesia, Spinal and Epidural, in Pregnancy

Treatments

Other: leg elevation

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Full 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

Enrollment

200 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Sequential Assignment

Masking

None (Open label)

200 participants in 2 patient groups

LE: leg elevation group
Experimental group
Description:
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
Treatment:
Other: leg elevation
CG: Control group
No Intervention group
Description:
The patients of this group will be positiooned in supine with 15° left tlit after spinal anesthesia. no leg elevation

Trial contacts and locations

1

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Central trial contact

Asma Ben Souissi; Mhamed Sami Mebazaa, professor

Data sourced from clinicaltrials.gov

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