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

• Sponsor: Tver Regional Perinatal Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT02237092
• Collaborator: (none)
• Enrollment: 196
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 8.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obstetric Anesthesia Problems; High-Risk Pregnancy	Procedure: Measurement of IAP	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 196 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Prevention
• Official Title: Effect of Intra-abdominal Pressure to the Level of the Sensory Block at Caesarean Section Under Spinal Anesthesia
• Study Start Date: Jun 1, 2011
• Actual Primary Completion Date: Jan 1, 2013
• Actual Study Completion Date: Jun 1, 2013

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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)

3. Obesity and IAP [Before spinal anesthesia, average 10 minutes.]

   Effect of obesity on the level of IAP

Secondary Outcome Measures

1. 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

2. 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

3. Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg [After spinal anesthesia, average 20 minutes.]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Tver Regional Perinatal Center	Tver		Russian Federation

Sponsors and Collaborators

• Tver Regional Perinatal Center

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tver Regional Perinatal Center
• ClinicalTrials.gov Identifier: NCT02237092
• Other Study ID Numbers: TR-1
• First Posted: Sep 11, 2014
• Last Update Posted: Jan 15, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No

Study Results

Participant Flow

Recruitment Details	Gestational age 36 - 40 weeks, Singleton pregnancies, Elective caesarean section

Arm/Group Title	Measurement of IAP
Arm/Group Description	The data obtained are in inches of water column were translated in millimeters of mercury. 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.
Period Title: Overall Study
STARTED	196
COMPLETED	196
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Measurement of IAP
Arm/Group Description	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.The data obtained are in inches of water column were translated in millimeters of mercury.
Overall Participants	196
Age (years) [Median (Standard Deviation) ]
Median (Standard Deviation) [years]	29.5 (5.7)
Sex/Gender, Customized (Pregnant women) [Number]
Female	196
Male	0
Height (cm) [Median (Standard Deviation) ]
Median (Standard Deviation) [cm]	163.9 (7.4)
Body mass index (kg/m^2) [Median (Standard Deviation) ]
Median (Standard Deviation) [kg/m^2]	30.8 (5.7)
Abdominal circumference (cm) [Median (Standard Deviation) ]
Median (Standard Deviation) [cm]	105.1 (10.2)

Outcome Measures

1. Primary Outcome

Title	The Level of Intra-abdominal Pressure (IAP)
Description	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.
Time Frame	Before spinal anesthesia, average 10 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Intra-abdominal Pressure (IAP) in Pregnant Women
Arm/Group Description	Average IAP in pregnant women
Measure Participants	196
Median (Standard Error) [mm Hg]	15.33 (0.17)

2. Primary Outcome

Title	Classification Grade of Intra-abdominal Hypertension (IAH)
Description	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)
Time Frame	Before spinal anesthesia, average 10 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Physiological Norm	Grade I	Grade II	Grade III
Arm/Group Description	(≤11,99 mm Hg)	(12 - 15.99 mm Hg)	(16 - 20.99 mm Hg)	(21 - 25.99 mm Hg)
Measure Participants	18	96	79	3
Median (Standard Error) [mm Hg]	11.60 (0.09)	14.11 (0.10)	17.43 (0.14)	21.56 (0.25)

3. Secondary Outcome

Title	Level of Sensory Blocks
Description	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
Time Frame	After spinal anesthesia, average 20 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Level of Sensory Block => Th4 (Spinal Anesthesia)	Level of Sensory Block < = Th5 (Spinal Anesthesia)
Arm/Group Description	Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia	Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
Measure Participants	62	134
Median (Standard Error) [Block level level of thoracic vertebrae]	3.5 (0.1)	5.8 (0.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intra-abdominal Pressure (IAP) in Pregnant Women, Grade I
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

4. Primary Outcome

Title	Obesity and IAP
Description	Effect of obesity on the level of IAP
Time Frame	Before spinal anesthesia, average 10 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	No Obesity	Obesity
Arm/Group Description	BMI < = 29.99	BMI = > 30.00
Measure Participants	98	98
Median (Standard Error) [mm Hg]	14.61 (0.20)	16.06 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intra-abdominal Pressure (IAP) in Pregnant Women, Grade I
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

5. Secondary Outcome

Title	The Level of IAP
Description	The level of IAP in obstetric patients in the groups with high ( => Th4) and low (< = Th5) blocks
Time Frame	After spinal anesthesia, average 20 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Level of Sensory Block => Th4 (Spinal Anesthesia)	Level of Sensory Block < = Th5 (Spinal Anesthesia)
Arm/Group Description	Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia	Pregnant with the level of sensory block in 20 minutes after the start of spinal anesthesia
Measure Participants	62	134
Median (Standard Error) [mm Hg]	16.5 (0.3)	14.0 (0.2)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intra-abdominal Pressure (IAP) in Pregnant Women, Grade I
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.02
	Comments
	Method	t-test, 2 sided
	Comments

6. Secondary Outcome

Title	Number of Pregnants With Blocks = > Th4 With IAP Higher or Less Than 16 mm Hg
Time Frame	After spinal anesthesia, average 20 minutes.

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Level of IAP < 16 mm Hg	Level of IAP = > 16 mm Hg
Arm/Group Description	number of pregnant women with Level of IAP < 16 mm Hg	number of pregnant women with Level of IAP = > 16 mm Hg
Measure Participants	114	82
Number [Number of pregnants with Blocks = > Th4]	29	33

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Intra-abdominal Pressure (IAP) in Pregnant Women, Grade I
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	NNT
	Comments
Method of Estimation	Estimation Parameter	Risk Ratio (RR)
	Estimated Value	1.58
	Confidence Interval	(2-Sided) 95%; 1.05 to 2.58
	Parameter Dispersion	Type: Value:
	Estimation Comments

Adverse Events

Time Frame	During the operation, an average of 30 minutes
Adverse Event Reporting Description	Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
Arm/Group Title	Level of Sensory Block => Th4 (Spinal Anesthesia)		Level of Sensory Block < = Th5 (Spinal Anesthesia)
Arm/Group Description	Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure		Hypotension: Decrease in systolic blood pressure below 90 mm Hg or more than 30% of the base line level of systolic blood pressure
All Cause Mortality
	Level of Sensory Block => Th4 (Spinal Anesthesia)		Level of Sensory Block < = Th5 (Spinal Anesthesia)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Level of Sensory Block => Th4 (Spinal Anesthesia)		Level of Sensory Block < = Th5 (Spinal Anesthesia)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	23/62 (37.1%)		17/134 (12.7%)
Cardiac disorders
Hypotension	23/62 (37.1%)	23	17/134 (12.7%)	17
Other (Not Including Serious) Adverse Events
	Level of Sensory Block => Th4 (Spinal Anesthesia)		Level of Sensory Block < = Th5 (Spinal Anesthesia)
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/62 (0%)		0/134 (0%)
Pregnancy, puerperium and perinatal conditions
Changing the type of anesthesia	0/62 (0%)	0	0/134 (0%)	0

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.