Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?

All over the world, spinal anesthesia is widely used in cesarean sections due to its superiority over general anesthesia. Due to reasons such as increased sensitivity to local anesthetics and increased intra-abdominal pressure in pregnant women, the frequency of hypotension increases by up to 70%. As a result of the blockage of sympathetic vasoconstrictor fibers originating from T1-L2 segments, loss of peripheral resistance, venous ponding occurs, and cardiac output decreases. Also, the level required for cesarean operation is T4 or T5, and the possibility of affecting the cardiac accelerator fibers, so bradycardia due to the increase in parasympathetic activity may deepen the hypotension. If postspinal hypotension is not managed correctly, it may lead to maternal and fetal complications. In addition to classical methods such as fluid loading and prophylactic vasoconstrictor application to prevent hypotension in pregnant women after spinal anesthesia, techniques such as wrapping the lower extremity, lifting, or applying both together have been in question.

Passive leg raise application is an easy method that allows the blood collected in the lower part of the body to participate in the central circulation with the effect of gravity. An increase in venous return occurs with the passage of blood from the lower extremities to the thorax. Thus, it leads to an increase in stroke volume and an increase in cardiac output. In this study, we aimed to determine the effectiveness of passive leg raising in preventing or reducing the depth of hypotension after spinal anesthesia in pregnant women who underwent cesarean section under spinal anesthesia.

Study Overview

• Status: Completed
• Conditions: Hypotension
• Intervention / Treatment: Other: Passive leg Raise; Other: control

• Study Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Antalya, Turkey, 07100
    • University of Health Sciences, Antalya Training and Research Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Parturients who are planned for the elective cesarean section

Exclusion Criteria:

• Failed spinal block
• Shift to general anesthesia
• Severe cardiac disease
• Hypertensive disorders of pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
PLACEBO_COMPARATOR: Control	Other: control; The controlled group was positioned in the normal supine position.
ACTIVE_COMPARATOR: Passive leg raise; group for passive leg raise	Other: Passive leg Raise; The intervention will be performed immediately after spinal anesthesia, and passive leg raise will be performed using two standard pillows placed under the heel so that the leg is approximately 30 cm above the horizontal plane of the table. The passive leg raising position will continue until the cord is clamped.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	Before the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	1 minute after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	2 minutes after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	3 minutes after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	4 minutes after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	5 minutes after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	7 minutes after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	9 minutes after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	11 minutes after the spinal anesthesia in the supine position
Systolic blood pressure	Systolic blood pressure will be recorded from the monitor	1 minute after the umblical cord clamping

Collaborators and Investigators

• Sponsor: Antalya Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2020
• Primary Completion (ACTUAL): December 31, 2020
• Study Completion (ACTUAL): January 31, 2021

Study Registration Dates

• First Submitted: December 13, 2020
• First Submitted That Met QC Criteria: December 13, 2020
• First Posted (ACTUAL): December 17, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 16, 2021
• Last Update Submitted That Met QC Criteria: February 15, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: cesarean section; spinal anesthesia; hypotension; passive leg raise
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: AntalyaEAH03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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