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

Anesthesia, Obstetrical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03164096
• Other study ID #: obstanesth
• Status: Recruiting
• Phase: Phase 4
• First received: May 20, 2017
• Last updated: March 28, 2018
• Start date: June 1, 2017
• Est. completion date: December 10, 2018

Study information

• Verified date: January 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 10, 2018
• Est. primary completion date: December 1, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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,

Related Conditions & MeSH terms

• Anesthesia, Obstetrical

Intervention

Drug:
• Bupivacaine Hydrochloride
intrathecal bupivacaine will be used for spinal anesthesia in obstetric patients undergoing C-section

Locations

Country	Name	City	State
Egypt	Assiut governorate	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	sensory level	effect of different parameters in sensory level	from allocation until 24 hours post-operative
Primary	motor block	effect of different parameters in motor level	from allocation until 24 hours post-operative
Secondary	hypotension	incidence of hypotension after spinal anesthesia	from allocation until 24 hours post-operative
Secondary	vasopressor consumption	total dose of ephedrine consumed by the patients	from allocation until 24 hours post-operative