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HypotensionNCT02146898

The Severity Of Hypotension Comparing Three Positions During Spinal Anesthesia For Cesarean Delivery

A study testing Position in people with Hypotension, run by Beth Israel Deaconess Medical Center at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The investigators intend to study the impact of patient positioning on the changes in blood pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that the changes in blood pressure relate to the speed with which the spinal medication rises. Read more about this study

Who is it for?
Ages 18 to 50 years, women only
Conditions the study is for
Hypotension
What is being tested?
Position
Could I receive a placebo?
No, everyone receives an active treatment
How many people
105 participants
Where
1 siteUnited States
Study dates
Sep 2013to Dec 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Singleton pregnancy
  • Term gestation
  • Scheduled cesarean delivery
  • Spinal anesthesia for delivery

Who cannot join

  • Significant fetal concerns
  • Polyhydramnios
  • Macrosomia
  • Morbid obesity (BMI >40)
  • Chronic hypertension
  • Gestational hypertension
Show all 9Show fewer
  • Preeclampsia
  • Type 1 diabetes
  • Contraindications to spinal anesthesia

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Beth Isreal Deaconess Medical Center

    Boston, Massachusetts, 02215

Other trials in United States

About this study

The investigators intend to study the impact of patient positioning on the changes in blood pressure after spinal anesthesia for cesarean delivery. The investigators hypothesized that the changes in blood pressure relate to the speed with which the spinal medication rises. By slowing the rise of spinal anesthesia, the investigators believe that the incidence and severity of hypotension might be reduced.

Read the detailed description

Spinal anesthesia is the most commonly used anesthetic for cesarean delivery. In part, this is due to the ease of administration, reliability and low rates of adverse effects. Additionally, the avoidance of general anesthesia allows the parturient to participate in the birth experience, despite being in surgery.

Although hyperbaric local anesthetic solutions have a remarkable record of safety, their use is not totally without risk. The side effects of spinal anesthesia are well described, but most notably include hypotension (low blood pressure). Spinal hypotension is primarily due to the vasodilatory effects of local anesthetics, and would occur in virtually all women if not prevented or treated.

The incidence of hypotension in both the literature and in clinical practice ranges from 30% to 50% of all patients. Recent literature using a continuous, non-invasive blood pressure monitor suggests that hypotension occurs with greater frequency and may be associated with a higher incidence of adverse effects to either mother or fetus. The incidence and degree of hypotension have been associated with fetal acidosis, which is a sign of either poor perfusion of the placental bed, or increased metabolism due to the blood pressure medications.

The most effective treatment for spinal hypotension is uterine displacement using a hip wedge; the use of a hip wedge after spinal anesthesia is a standard of care. Other treatment, including fluid administration of either crystalloid or colloid, are either partially effective, clinical impractical, or result in administering large doses of medications that may have negative effects on the fetus.

Epidural anesthesia is associated with a reduction in the incidence and severity of hypotension compared with spinal anesthesia. This is believed to be due to the slower onset of sympathetic blockade with epidural anesthesia; this slow onset allows the physiologic compensation to changes in blood pressure. Unfortunately, the slower onset and lower reliability of epidural anesthesia prevents routine use in clinical practice for cesarean delivery.

The investigators hypothesize that the position patients are in during spinal placement might play a role in the severity of maternal hypotension. Interestingly, very few studies have investigated this posibility. Gori, et al. (1) studied influence of seated versus lateral positioning for spinal placement in Cesarean section. They found no significant differences in onset times, Bromage score for motor block, recovery dynamics, and use of ephedrine in two different positions; however, they did not compare the incidence and severity of spinal hypotension. Yun, et al. (2) found that the severity and duration of hypotension were greater when hyperbaric bupivacaine and fentanyl were induced in the sitting position compared to lateral.

Of notice, in all these studies, the authors focused on the immediate positions when the spinal mediation was injected; none has examined the effect of positioning after injection during phase when spinal anesthesia is rising.

Density differences between intrathecal injectate and CSF may explain the observed postural differences in extent of sensory block. Thus, the height of spinal anesthesia blockade could be affected by patient positioning during and after spinal injection. A small incline in positioning immediately after spinal injection may slow the rise of spinal blockade without affecting the duration of spinal anesthesia. In the current protocol, the investigators hypothesize that by slowing the rise of spinal anesthesia, the investigators might reduce the severity of hypotension.

Conditions
Hypotension
Being tested
Position
Keywords
spinal anesthesia, hypotension, pregnancy
Medical subject headings
Hypotension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PositionOther

Study groups in NCT02146898
Study groupRoleWhat they receive
LateralActive comparatorpatient placed in the lateral postion for spinal anesthesia
Receives: Other: Position
SittingActive comparatorpatient placed in the sitting position for spinal anestheisa, then supine
Receives: Other: Position
ReclineActive comparatorpatient placed in the sitting position for spinal anesthesia administration. After spinal placed, the patient turned to a 30-degree upperbody tilt, followed by a slow recline to supine over 5 minutes
Receives: Other: Position

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. change in blood pressure

    percentage change in blood pressure after spinal anesthesia

    Measured: 20 minutes

Secondary outcomes (1)
  1. IV fluid administration

    Difference in IV fluid requirements

    Measured: 20 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 May 2014 (estimated)
  2. Study startSep 2013
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
105 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02146898
Sponsor's protocol ID
2013P000171
Status last verified
Jan 2017
First submitted
19 May 2014
Last updated
4 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Position in people with Hypotension, run by Beth Israel Deaconess Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

change in blood pressure (time frame: 20 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.

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