Does Ultrasound Increase the First-pass Success of Epidural Space Identification in Obese Parturients
Does Preprocedural Ultrasound Exam of Lumbar Spine Increase the First-pass Success Rate of Epidural Space Identification Among Obese Parturients: A Randomized Controlled Open Trial
1 other identifier
interventional
56
1 country
1
Brief Summary
Obesity is associated with difficulties in epidural space catheterization. The investigators want to prove that a pre-procedural ultrasound exam of lumbar spine increase the first-pass success rate of the epidural space identification among obese parturients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 6, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 8, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2020
CompletedFirst Submitted
Initial submission to the registry
March 29, 2020
CompletedFirst Posted
Study publicly available on registry
April 20, 2020
CompletedMay 5, 2020
March 1, 2019
2 days
March 29, 2020
May 4, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Success of the epidural space identification at the first needle pass
Succes rate of the epidural space identification at the first needle pass (first skin puncture and without needle redirection) for each group
Baseline up to 1 hour
Secondary Outcomes (11)
Success of the epidural space identification at the first skin puncture
Baseline up to 1 hour
Number of skin punctures
Baseline up to 1 hour
Number of needle redirections
Baseline up to 1 hour
Number of intervertebral space punctured
Baseline up to 1 hour
Duration of the epidural procedure
Baseline up to 1 hour
- +6 more secondary outcomes
Study Arms (2)
palpation
NO INTERVENTIONUsual method to determinate needle puncture site
Ultrasound
EXPERIMENTALUltrasound preprocedural exam used to determinate needle puncture site
Interventions
Preprocedural ultrasound exam of lumbar spine used to determinate needle puncture site
Eligibility Criteria
You may qualify if:
- Full-term parturients (≥ 37 weeks of amenorrhea)
- With pre-pregnancy BMI ≥ 30 kg/m2
- Admit for a vaginal delivery
- Receiving labour epidural analgesia
You may not qualify if:
- Usual contraindications for neuraxial anesthesia (thrombocytopenia, coagulopathy, uncorrected hypovolemia, infected puncture site, intracranial hypertension)
- Emergency maternal and foetal cases
- Twin pregnancy
- Marked spinal deformity ou previous spinal surgery
- Refusal to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University Hospital of Cote de Nacre
Caen, 14000, France
Related Publications (1)
Balki M. Locating the epidural space in obstetric patients-ultrasound a useful tool: continuing professional development. Can J Anaesth. 2010 Dec;57(12):1111-26. doi: 10.1007/s12630-010-9397-y. Epub 2010 Nov 11. English, French.
PMID: 21063818RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lise-Amelie ZERAJIC, MD
Anesthesiologist Intensivist Physician
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 29, 2020
First Posted
April 20, 2020
Study Start
April 6, 2019
Primary Completion
April 8, 2019
Study Completion
February 28, 2020
Last Updated
May 5, 2020
Record last verified: 2019-03
Data Sharing
- IPD Sharing
- Will not share