N/A
N=140
Dural Puncture Epidural Versus Epidural Anesthesia for Cesarean Delivery
Pain Levels
Bottom Line
View on ClinicalTrials.gov: NCT03915574 ↗Enrolled (actual)
140
Serious AEs
0.0%
Results posted
Dec 2023
Primary outcome: Primary: Onset Time of Surgical Anesthesia — 422; 655 seconds
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 25G Dural Puncture Epidural (Device); Standard Epidural (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Arkansas
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Onset Time of Surgical Anesthesia |
422; 655 | — |
| SECONDARY Number of Participants With Inadequate Neuraxial Analgesia or Anesthesia |
11; 24 | — |
Summary
This study will compare two anesthetics techniques called Dural Puncture Epidural (DPE) and Standard Epidural as to which of the two can provide faster and potentially better at providing pain relief for cesarean sections. It will also compare these two anesthetics techniques on the percentage of women who require additional drugs to control pain during their cesarean deliveries. The results of this study will help anesthesiologists know which anesthetic technique can provide faster and potentially better at providing pain relief for cesarean sections.
Eligibility Criteria
Inclusion Criteria
- Singleton pregnancy
- Gestation > 36 weeks
- ASA class II and III
- Provides written consent
- Infant of mother
- Elective or non-urgent cesarean delivery
Exclusion Criteria
- Patient refusal
- Urgent/emergent cesarean sections
- ASA and IV or above
- Unable to understand English
- Significant back surgery or scoliosis
- Lethal fetal abnormality or likely to affect APGAR scores
- Weight > 120 kg
- Height < 150 cm
- Allergy to study solutions
Data sourced from ClinicalTrials.gov (NCT03915574). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.