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

Not Applicable

Completed

• Conditions: Obstetric Anesthesia Problems; High-Risk Pregnancy
• Interventions: Procedure: Measurement of IAP

• Registration Number: NCT02237092
• Lead Sponsor: Tver Regional Perinatal Center

Brief Summary

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.

Detailed Description

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

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2013-01
• Study Completion: 2013-06
• Study First Submitted: 2014-09-02
• Study First Submitted QC: 2014-09-10
• Results First Submitted: 2014-09-10
• Study First Posted: 2014-09-11
• Results First Submitted QC: 2014-09-30
• Results First Posted: 2014-10-02
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-02
• Last Update Posted: 2019-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Measurement of IAP	Measurement of IAP	The data obtained are in inches of water column were translated in millimeters of mercury.

Primary Outcome Measures

Name	Time	Method
Classification Grade of Intra-abdominal Hypertension (IAH)	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)
The Level of Intra-abdominal Pressure (IAP)	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.
Obesity and IAP	Before spinal anesthesia, average 10 minutes.	Effect of obesity on the level of IAP

Secondary Outcome Measures

Name	Time	Method
Level of Sensory Blocks	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
The Level of IAP	After spinal anesthesia, average 20 minutes.	The level of IAP in obstetric patients in the groups with high ( =\> Th4) and low (\< = Th5) blocks
Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg	After spinal anesthesia, average 20 minutes.

Trial Locations

Locations (1)

Tver Regional Perinatal Center; 🇷🇺 Tver, Russian Federation