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

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.

Study Overview

• Status: Completed
• Conditions: Obstetric Anesthesia Problems; High-Risk Pregnancy
• Intervention / Treatment: Procedure: Measurement of IAP

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 Type: Interventional
• Enrollment (Actual): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Tver, Russian Federation
    • Tver Regional Perinatal Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Measurement of IAP; The data obtained are in inches of water column were translated in millimeters of mercury.	Procedure: 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, for 10 minutes, after quiet breathing pregnant at the time of expiration.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tver Regional Perinatal Center
• Investigators: Principal Investigator: Alexandr Ronenson, PhD student, Tver Regional Perinatal Center; Study Director: Sergei Sitkin, DMedSc, Tver State Medical Academy

Publications and helpful links

General Publications

• S. Sitkin, A. Ronenson, J. Savelieva, M. Cherdyntsev. Prediction of high level spinal block in caesarean section. Regional Anesthesia and Pain Medicine. - 2012. - Volume 37. - Sup 1 5. - p. 183.
• Sitkin, S.; Ronenson, A.; Wagle, S.; Saveleva, J. Effect of intra-abdominal pressure of pregnancy for the development of spinal block for cesarean section: 11AP1-10. European Journal of Anaesthesiology. - 2013 - Volume 30. - Sup 51. - p. 167-168.
• Sitkin S., Ronenson A.M., Savelieva J.V., Wagle S. Influence of intra-abdominal pressure (iap) and body mass index (bmi) in pregnancy on the development of spinal block for cesarean section. Regional Anesthesia and Pain Medicine, Volume 38, Number 5, Supplement 1 5, September-October. - 2013. - p. 179

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): January 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: September 2, 2014
• First Submitted That Met QC Criteria: September 10, 2014
• First Posted (Estimate): September 11, 2014

Study Record Updates

• Last Update Posted (Actual): January 15, 2019
• Last Update Submitted That Met QC Criteria: January 2, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: TR-1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO