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

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Anesthesia, Obstetrical	Drug: Bupivacaine Hydrochloride	Phase 4

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• 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
• 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
• Actual Study Start Date: June 1, 2017
• Estimated Primary Completion Date: December 1, 2018
• Estimated Study Completion Date: December 10, 2018

Arms and Interventions

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 Name: intrathecal bupivacaine

Outcome Measures

Primary Outcome Measures :

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

Secondary Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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,

Contacts and Locations

Locations

Egypt

Assiut governorate; Recruiting

Assiut, Egypt

Contact: Ghada M Aboelfadl, MD 01005802086 ghadafadl77@gmail.com

Sponsors and Collaborators

Assiut University

More Information

• Responsible Party: Ghada Mohammed AboelFadl, Principal Investigator, Assiut University
• ClinicalTrials.gov Identifier: NCT03164096
• Other Study ID Numbers: obstanesth
• First Posted: May 23, 2017
• Last Update Posted: March 29, 2018
• Last Verified: January 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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

Additional relevant MeSH terms:

Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents