Status:
WITHDRAWN
Superiority of Epidural Placement Technique Using EpiFaith Syringe
Lead Sponsor:
Harvard Medical School (HMS and HSDM)
Conditions:
Anesthesia
Eligibility:
FEMALE
18+ years
Phase:
NA
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 learn...
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 ela...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2026
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04793373
Start Date
May 15 2022
End Date
June 30 2026
Last Update
July 21 2023
Active Locations (1)
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1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115