Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section

Not Applicable

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

• 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

Study Timeline

• Study Start: 2018-01-10
• Status Verified: 2018-03
• Primary Completion: 2018-03-22
• Study First Submitted: 2018-03-22
• Study First Submitted QC: 2018-03-28
• Last Update Submitted: 2018-03-28
• Study First Posted: 2018-04-04
• Last Update Posted: 2018-04-04
• Study Completion: 2018-12-31

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

Primary Outcome Measures

Name	Time	Method
Incidence of post spinal hypotension	during the first 30minutes after the spinal anesthesia	change of systolic blood pressure from baseline\< 90 mmHg

Secondary Outcome Measures

Name	Time	Method
Lowest systolic blood pressure	during the first 30 minutes following spinal anesthesia	the lowest systolic blood pressure observed after spinal anesthesia
ephedrine consumption	during the first 30 minutes following the spinal anesthesia	total dose of Ephedrine received to treat post spinal hypotension
Fetal ph	30 minutes after spinal anesthesia	fetal ph measured with blood gas analysis
Fetal blood lactates	30 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