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Completed

NCT Number: NCT02237092

Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia

It is known that an increase in intra-abdominal pressure (IAP) causes a decrease in the volume of cerebrospinal fluid in the lumbar and lower thoracic region, which may contribute to the development of more high spinal block.

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Key information

Conditions

Obstetric Anesthesia Problems High-Risk Pregnancy

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Tver Regional Perinatal Center

Tver', Russia

About this study

There is a hypothesis, the higher the level of intra-abdominal pressure, the greater the likelihood of developing a high-level (=>Th4) sensor block.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Gestational age 36 - 40 weeks
  • Singleton pregnancies
  • Elective caesarean section

Exclusion criteria

  • Gestational age <= 35 weeks
  • Twins pregnancies
  • Disease the cardiovascular system (hypertension, etc.)
  • Non-elective caesarean section

Treatment and study plan

Measurement of IAP

Procedure

The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, for 10 minutes, after quiet breathing pregnant at the time of expiration.

Primary outcomes

  1. The Level of Intra-abdominal Pressure (IAP)

    Time frame: Before spinal anesthesia, average 10 minutes.

    Measurement of IAP: The level of intra-abdominal pressure was measured via a Foley catheter through the urinary bladder. After the introduction of a 30 mL of warm saline. Measurement of the water column in the system was made from the zero level to the mid-axillary line, after quiet breathing pregnant at the time of expiration. The data obtained are in inches of water column were translated in millimeters of mercury.

  2. Classification Grade of Intra-abdominal Hypertension (IAH)

    Time frame: Before spinal anesthesia, average 10 minutes.

    Average IAP in pregnant women with different Grade of intra-abdominal hypertension Physiological norm (≤11,99 mm Hg) Grade I (12 - 15.99 mm Hg) Grade II (16 - 20.99 mm Hg) Grade III (21 - 25.99 mm Hg)

  3. Obesity and IAP

    Time frame: Before spinal anesthesia, average 10 minutes.

    Effect of obesity on the level of IAP

Secondary outcomes

  1. Level of Sensory Blocks

    Time frame: After spinal anesthesia, average 20 minutes.

    Block level of thoracic vertebrae are reported for pregnant women who had level of sensory block higher than 4 thoracic vertebra and less than 5 thoracic vertebra

  2. The Level of IAP

    Time frame: After spinal anesthesia, average 20 minutes.

    The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks

  3. Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg

    Time frame: After spinal anesthesia, average 20 minutes.

Sponsors and collaborators

Lead sponsor

Tver Regional Perinatal Center

Other

Registry information

Acronym: IAPSB

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 11, 2014
Registry last updated
Jan 15, 2019

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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