NCT02883075

Brief Summary

Multiple studies have compared spinal anesthetic performed supine versus lateral, with varying results, in parturients having elective cesarean section. Needle positioning during spinal placement has also been examined. No positioning techniques have demonstrated definitive superiority for hemodynamic stability. Investigators propose that following spinal placement in the sitting position if the patient is placed in a lateral position for 90 seconds prior to turning them supine, hemodynamic changes caused by sympathectomy related to the subarachnoid block can be avoided. This is the first study to examining the influence of position changes after spinal anesthetic placement in the sitting position, which includes hemodynamic variables not previously studied including cardiac output, TPR (total peripheral resistance) and pulse pressure variation (PPV).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for not_applicable pregnancy

Timeline
Completed

Started Aug 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 21, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 30, 2016

Completed
11 months until next milestone

Study Start

First participant enrolled

August 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 26, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 26, 2018

Completed
Last Updated

February 28, 2019

Status Verified

November 1, 2018

Enrollment Period

1.2 years

First QC Date

July 21, 2016

Last Update Submit

February 26, 2019

Conditions

PregnancyAnesthesia

Outcome Measures

Primary Outcomes (2)

  • Heart rate

    Continuous Heart rate (beats per minute) measurements.

    Immediately before spinal anesthestic placement through placental delivery

  • Blood pressure

    Continuous Blood pressure (mmHg) measurements

    Immediately before spinal anesthetic placement through placental delivery

Secondary Outcomes (7)

  • Incidence of nausea and vomiting

    Number of events spinal anesthetic placement through placental delivery

  • Anti-emetic medication

    Number of events spinal anesthetic placement through placental delivery

  • Incidence of vasopressor usage

    Spinal anesthetic placement through placental delivery

  • Total vasopressor usage

    Spinal anesthetic placement through placental delivery

  • Non Invasive Cardiovascular measurements: cardiac output

    Spinal anesthetic placement through placental delivery

  • +2 more secondary outcomes

Study Arms (3)

Supine position

SHAM COMPARATOR

Supine position Supine position after placement of spinal anesthetic

Other: Supine position

Right lateral position

ACTIVE COMPARATOR

Right lateral position Right lateral after placement of spinal anesthetic

Other: Right lateral position

Left lateral position

ACTIVE COMPARATOR

Left lateral position Left lateral after placement of spinal anesthetic

Other: Left lateral position

Interventions

Supine positionOTHER

Spinal anesthesia in sitting position then 2 minutes in Supine position after spinal anesthetic administration

Supine position
Right lateral positionOTHER

Spinal anesthesia in sitting position then 2 minutes in the right lateral position after spinal anesthetic administration

Right lateral position
Left lateral positionOTHER

Spinal anesthesia in sitting position then 2 minutes in the left lateral position after spinal anesthetic administration

Left lateral position

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Parturients undergoing elective cesarean section under spinal anesthesia
  • Singleton intrauterine pregnancy with appropriate gestational age fetus (AGA) at gestational age 37 to 42 weeks

You may not qualify if:

  • Large for gestational age, small for gestational age, and multiple gestations
  • Patients with cardiovascular disease like hypertension, etc.
  • Non-English or non-Spanish speakers
  • BMI \>40
  • Inadequate or failed blocks and inadvertently high levels of spinal blockade will be dropped from the study
  • Incarcerated parturients
  • Expected heavy bleeding (placenta accreta, vascular anomaly, etc.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UTMB

Galveston, Texas, 77555, United States

Location

MeSH Terms

Interventions

Supine Position

Intervention Hierarchy (Ancestors)

PostureMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ranganathan Govindaraj, MD, FRCA

    The University of Texas Medical Branch, Galveston

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 21, 2016

First Posted

August 30, 2016

Study Start

August 1, 2017

Primary Completion

September 26, 2018

Study Completion

November 26, 2018

Last Updated

February 28, 2019

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations

US(1)