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Superiority of Epidural Placement Technique Using EpiFaith Syringe

Sponsor
Harvard Medical School (HMS and HSDM) (Other)
Overall Status
Recruiting
CT.gov ID
NCT04793373
Collaborator
(none)
680
Enrollment
1
Location
2
Arms
49.5
Anticipated Duration (Months)
13.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to evaluate the impact of EpiFaith® syringe on the establishment of successful epidural labor analgesia, change of elapsed time for identification of epidural space, and learning curve of CA-1 residents.

Condition or Disease Intervention/Treatment Phase
  • Device: Syringe
 N/A

Detailed Description

We hypothesize that EpiFaith® syringe, in comparison with conventional glass syringe, will result in a similar overall success rate for catheter placement, but with a larger reduction in change of elapsed time for identification of epidural space and catheter placement of each practitioner. Moreover, we hypothesize that the cumulative learning summary curve using EpiFaith® syringe will be higher than conventional glass syringe in resident trainees, which will show the possible value of EpiFaith® syringe for teaching and learning obstetric epidural anesthesia.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
680 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Superiority of Epidural Placement Technique Using EpiFaith® Syringe Versus Conventional Glass Syringe in Laboring Paturients
Actual Study Start Date :
May 15, 2022
Anticipated Primary Completion Date :
Dec 31, 2025
Anticipated Study Completion Date :
Jun 30, 2026

Arms and Interventions

Arm Intervention/Treatment
Experimental: EpiFaith® group

Study subject will have the epidural placement with an EpiFaith® syringe.

Device: Syringe
A syringe will be used to detect the loss of resistance and needle's entry of epidural space.
Active Comparator: Conventional group

Study subject will have the epidural placement with a conventional glass syringe.

Device: Syringe
A syringe will be used to detect the loss of resistance and needle's entry of epidural space.

Outcome Measures

Primary Outcome Measures

  1. Success of epidural localization [30 minutes]

    Defined as the catheter can be inserted into epidural space successfully; no occurence of inadvertent dural puncture

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Females 18 years of age and older at screening

  • Request labor epidural analgesia

  • Able to give informed consent to participate in the study

  • American Society of Anesthesiologists (ASA) class Ⅰ to Ⅲ health status

  • BMI ≤ 40 kg/m2

Exclusion Criteria:

  • BMI > 40 kg/m2; any contraindication to neuraxial anesthesia (coagulopathy, uncorrected hypovolemia, increased intracranial pressure, or local skin infection)

  • Cardiac disease history, marked spinal deformity, previous spinal surgery, or impalpable anatomical landmarks

  • Any allergy to bupivacaine or fentanyl

Contacts and Locations

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115

Sponsors and Collaborators

  • Harvard Medical School (HMS and HSDM)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jie Zhou, Assistant Professor, Harvard Medical School (HMS and HSDM)
ClinicalTrials.gov Identifier:
NCT04793373
Other Study ID Numbers:
  • 2020P000677
First Posted:
Mar 11, 2021
Last Update Posted:
Jun 7, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Product Manufactured in and Exported from the U.S.:
No

Study Results

No Results Posted as of Jun 7, 2022