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Completed

NCT Number: NCT04673253

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.

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Key information

Conditions

Hypotension Cardiovascular Diseases Vascular Diseases

Age range

18 year–40 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences, Antalya Training and Research Hospital

Antalya, 07100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Passive leg Raise

Other

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.

Control

Other

The controlled group was positioned in the normal supine position.

Primary outcomes

  1. Systolic blood pressure

    Time frame: Before the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  2. Systolic blood pressure

    Time frame: 1 minute after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  3. Systolic blood pressure

    Time frame: 2 minutes after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  4. Systolic blood pressure

    Time frame: 3 minutes after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  5. Systolic blood pressure

    Time frame: 4 minutes after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  6. Systolic blood pressure

    Time frame: 5 minutes after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  7. Systolic blood pressure

    Time frame: 7 minutes after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  8. Systolic blood pressure

    Time frame: 9 minutes after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  9. Systolic blood pressure

    Time frame: 11 minutes after the spinal anesthesia in the supine position

    Systolic blood pressure will be recorded from the monitor

  10. Systolic blood pressure

    Time frame: 1 minute after the umblical cord clamping

    Systolic blood pressure will be recorded from the monitor

Sponsors and collaborators

Lead sponsor

Antalya Training and Research Hospital

Other Gov

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Dec 17, 2020
Registry last updated
Feb 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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