Leg Elevation for Prevention of Post Spinal Hypotension in Cesarean Section

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

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.

Study Overview

• Status: Unknown
• Conditions: Effects of; Anesthesia, Spinal and Epidural, in Pregnancy
• Intervention / Treatment: Other: leg elevation

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 Type: Interventional
• Enrollment (Anticipated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asma Ben Souissi; Phone Number: 0021698336883; Email: bsouissiasma@gmail.com

Study Locations

• Tunisia
  • Tunis
    • La Marsa, Tunis, Tunisia, 2046
      • Recruiting
      • Mongi Slim hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LE: leg elevation group; 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; intra operative position that consists in leg elevation with a 30 cm height pillow under the patient's heels
No Intervention: CG: Control group; 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?

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

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital
• Investigators: Principal Investigator: Mhamed Sami Mebazaa, Professor, Mongi Slim hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): March 22, 2018
• Study Completion (Anticipated): December 31, 2018

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 28, 2018
• First Posted (Actual): April 4, 2018

Study Record Updates

• Last Update Posted (Actual): April 4, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: Mater1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No