The Effect of Some Parturients' Characteristics on Sensory Block Level After Spinal Anesthesia

NCT ID: NCT03164096

Last Updated: 2018-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2018-12-10

Brief Summary

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Although the exact mechanism remains unknown, the association of pregnancy and decreased local anesthetic requirement is clear. demonstrated that more local anesthetic is required for cesarean section under combined spinal-epidural anesthesia in preterm compared with term patients.

Detailed Description

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However, in pregnant patients, venous engorgement is prominent in the supine but not the lateral position, which suggests direct compression of the inferior vena cava by the gravid uterus. Second, an increase in intraabdominal pressure may affect the retroperitoneal area and may cause inward movement of soft tissue in the intervertebral foramina. Recent magnetic resonance imaging studies in pregnant patients, although without intraabdominal pressure measurements, suggested the latter because they showed limited contact of engorged veins along the dural sac which may therefore not be responsible for compression of the dura.

If elevated intraabdominal pressure contributes to high anesthetic spread during pregnancy, one would expect a relationship between intraabdominal pressure and maximum sensory block level.

Conditions

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Anesthesia, Obstetrical

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

evaluating relationship of sensory level and other patient factors
Primary Study Purpose

SCREENING

Blinding Strategy

NONE

Study Groups

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intrathecal bupivacaine

intrathecal bupivacaine hydrochloride 0.5%,12.5mg

Group Type EXPERIMENTAL

Bupivacaine Hydrochloride

Intervention Type DRUG

intrathecal bupivacaine will be used for spinal anesthesia in obstetric patients undergoing C-section

Interventions

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Bupivacaine Hydrochloride

intrathecal bupivacaine will be used for spinal anesthesia in obstetric patients undergoing C-section

Intervention Type DRUG

Other Intervention Names

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intrathecal bupivacaine

Eligibility Criteria

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Inclusion Criteria

* adult female partner
* aged 18 to 40 years.
* scheduled for elective cesarean section.

Exclusion Criteria

* Patients with coagulopathy or under anti-coagulation therapy.
* Gastrointestinal disease,
* motion sickness.
* diabetes mellitus.
* Patients with preeclampsia,
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Ghada Mohammed AboelFadl

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Assiut governorate

Asyut, , Egypt

Site Status RECRUITING

Countries

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Egypt

Facility Contacts

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Ghada M Aboelfadl, MD

Role: primary

01005802086

Other Identifiers

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obstanesth

Identifier Type: -

Identifier Source: org_study_id

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