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

Obstetric Anesthesia Problems Clinical Trial

— IAPSB  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02237092
• Other study ID #: TR-1
• Status: Completed
• Phase: N/A
• Start date: June 2011
• Est. completion date: June 2013

Study information

• Verified date: January 2019
• Source: Tver Regional Perinatal Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 196
• Est. completion date: June 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• High-Risk Pregnancy
• Obstetric Anesthesia Problems

Intervention

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.

Locations

Country	Name	City	State
Russian Federation	Tver Regional Perinatal Center	Tver

Sponsors (1)

Lead Sponsor	Collaborator
Tver Regional Perinatal Center

Country where clinical trial is conducted

Russian Federation, 

References & Publications (3)

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.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, Supp

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.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	Obesity and IAP	Effect of obesity on the level of IAP	Before spinal anesthesia, average 10 minutes.
Secondary	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.
Secondary	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.
Secondary	Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg		After spinal anesthesia, average 20 minutes.

External Links

•   Patent on the research