NCT03164096

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 20, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 23, 2017

Completed
9 days until next milestone

Study Start

First participant enrolled

June 1, 2017

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
9 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 10, 2018

Completed
Last Updated

March 29, 2018

Status Verified

January 1, 2018

Enrollment Period

1.5 years

First QC Date

May 20, 2017

Last Update Submit

March 28, 2018

Conditions

Anesthesia, Obstetrical

Outcome Measures

Primary Outcomes (2)

  • sensory level

    effect of different parameters in sensory level

    from allocation until 24 hours post-operative

  • motor block

    effect of different parameters in motor level

    from allocation until 24 hours post-operative

Secondary Outcomes (2)

  • hypotension

    from allocation until 24 hours post-operative

  • vasopressor consumption

    from allocation until 24 hours post-operative

Study Arms (1)

intrathecal bupivacaine

EXPERIMENTAL

intrathecal bupivacaine hydrochloride 0.5%,12.5mg

Drug: Bupivacaine Hydrochloride

Interventions

Bupivacaine HydrochlorideDRUG

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

Also known as: intrathecal bupivacaine
intrathecal bupivacaine

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Patients with coagulopathy or under anti-coagulation therapy.
  • Gastrointestinal disease,
  • motion sickness.
  • diabetes mellitus.
  • Patients with preeclampsia,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut governorate

Asyut, Egypt

RECRUITING

MeSH Terms

Interventions

Bupivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: evaluating relationship of sensory level and other patient factors
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 20, 2017

First Posted

May 23, 2017

Study Start

June 1, 2017

Primary Completion

December 1, 2018

Study Completion

December 10, 2018

Last Updated

March 29, 2018

Record last verified: 2018-01

Locations

EG(1)