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

• ClinicalTrials.gov Identifier: NCT03164096
• Recruitment Status: Unknown
• First Posted: May 23, 2017
• Last Update Posted: March 29, 2018
• Sponsor: Assiut University
• Information provided by (Responsible Party): Ghada Mohammed AboelFadl, Assiut University

Tracking Information

• First Submitted Date: May 20, 2017
• First Posted Date: May 23, 2017
• Last Update Posted Date: March 29, 2018
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: December 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: May 22, 2017)

• sensory level [ Time Frame: from allocation until 24 hours post-operative ]
  effect of different parameters in sensory level
• motor block [ Time Frame: from allocation until 24 hours post-operative ]
  effect of different parameters in motor level

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: May 22, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The Effect of Some Parturients' Characteristics on Sensory Block Level After Spinal Anesthesia
• 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
• Brief 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.

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
• Study Phase: Phase 4

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:

evaluating relationship of sensory level and other patient factors

Masking: None (Open Label)
Primary Purpose: Screening

• Condition: Anesthesia, Obstetrical

Intervention

Drug: Bupivacaine Hydrochloride

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

Other Name: intrathecal bupivacaine

Study Arms

Experimental: intrathecal bupivacaine

intrathecal bupivacaine hydrochloride 0.5%,12.5mg

Intervention: Drug: Bupivacaine Hydrochloride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 22, 2017): 100
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 10, 2018
• Estimated Primary Completion Date: December 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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,

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 40 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Egypt

Administrative Information

• NCT Number: NCT03164096
• Other Study ID Numbers: obstanesth
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• 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

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Ghada Mohammed AboelFadl, Assiut University
• Study Sponsor: Assiut University
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Assiut University
• Verification Date: January 2018