Clinical trial NCT03539796: Epidural Technique: Does it Really Matter to the Patient?
Official title: Dural Puncture Epidural Technique vs. Standard Epidurals vs. Combined-Spinal Epidurals for Cesarean Sections: Does it Really Matter to the Patient?
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Keywords: dural puncture epidurals
DPE
combined-spinal epidural
CSE
cesarean section
patient satisfaction
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2018-05-29
Enrollment: 57
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.

Detailed description: There are approximately 4 million child birth deliveries in US hospitals per year, and 1.3million of those births are via cesarean section (c-section). With this type of surgery, obstetric anesthesiology plays an important role. The main objective of this study will be to determine if the dural puncture epidural (DPE) provides superior analgesia and better patient satisfaction when compared to traditional epidurals for cesarean sections, and to also determine if patient satisfaction in the DPE group is comparable to that of the CSE technique.

Eligibility criteria: Inclusion Criteria:

* Female parturient at Grady Memorial Hospital must meet one of the following:
* Parturient having a scheduled or elective cesarean section
* Parturient not having primary cesarean-section
* At least 18 years of age
* Subject has signed the informed consent

Exclusion Criteria:

* Parturient who is unable or unwilling to sign the consent form
* Parturient having primary cesarean section
* Parturient with known complex cardiac disease (ex...aortic/mitral stenosis, aortic aneurysms, congenital heart disease with residual defects...etc)
* Parturient with any contraindication to neuraxial anesthesia such as coagulopathy, infection, or patient refusal
* Parturient having a fourth or more cesarean section

Primary outcomes:
measure: Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. EPI group
timeFrame: 1 hour after procedure
measure: Percent of patients with Numeric Pain Rating Score (NPRS) <3 in the DPE vs. EPI group.
timeFrame: 1 hour after procedure
measure: Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group
timeFrame: 1 hour after procedure
Secondary outcomes:
measure: Percent of patients required rescue analgesia in the DPE vs. EPI group
timeFrame: During labor/delivery (up to 24 hours)
measure: Percent of patients required rescue analgesia in the DPE vs. CSE group
timeFrame: During labor/delivery (up to 24 hours)
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Grady Health System (CRN)
state: Georgia
Study officials:
affiliation: Emory University
name: Dawn Manning-Williams, MD
role: PRINCIPAL_INVESTIGATOR
References: