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

March 28, 2018 updated by: Ghada Mohammed AboelFadl, Assiut University

The Effect of Body Mass Index, Intra-abdominal Pressure, Abdominal Girth and Waist Circumference on Sensory Block Level After Single-shot Spinal Anesthesia for Cesarean Section

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Assiut, Egypt
        • Recruiting
        • Assiut governorate
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intrathecal bupivacaine
intrathecal bupivacaine hydrochloride 0.5%,12.5mg
Drug: Bupivacaine Hydrochloride
intrathecal bupivacaine will be used for spinal anesthesia in obstetric patients undergoing C-section
Other Names:
  • intrathecal bupivacaine

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
sensory level
Time Frame: from allocation until 24 hours post-operative
effect of different parameters in sensory level
from allocation until 24 hours post-operative
motor block
Time Frame: from allocation until 24 hours post-operative
effect of different parameters in motor level
from allocation until 24 hours post-operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypotension
Time Frame: from allocation until 24 hours post-operative
incidence of hypotension after spinal anesthesia
from allocation until 24 hours post-operative
vasopressor consumption
Time Frame: from allocation until 24 hours post-operative
total dose of ephedrine consumed by the patients
from allocation until 24 hours post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2017

Primary Completion (Anticipated)

December 1, 2018

Study Completion (Anticipated)

December 10, 2018

Study Registration Dates

First Submitted

May 20, 2017

First Submitted That Met QC Criteria

May 22, 2017

First Posted (Actual)

May 23, 2017

Study Record Updates

Last Update Posted (Actual)

March 29, 2018

Last Update Submitted That Met QC Criteria

March 28, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • obstanesth

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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