Dural Puncture Epidural Technique vs. Standard Epidurals vs. Combined-Spinal Epidurals for Cesarean Sections: Does it Really Matter to the Patient?
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Emory University
- Enrollment
- 57
- Locations
- 1
- Primary Endpoint
- Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Dural puncture epidurals (DPE)
Dural puncture epidurals for cesarean section.
Intervention: Dural puncture epidurals (DPE) (Procedure)
Traditional epidurals (EPI)
Traditional epidurals (EPI) for cesarean section.
Intervention: Traditional epidurals (EPI) (Procedure)
Combined-spinal epidural technique (CSE)
Combined-spinal epidural technique (CSE) for cesarean section.
Intervention: Combined-spinal epidural technique (CSE) (Procedure)
Outcomes
Primary Outcomes
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group
Time Frame: 1 hour after procedure
The blinded investigator will visit the patient within 1hour of block placement and ask to select Numeric Pain Rating Score (NPRS) (1-10) during procedure.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Percent of patients with Numeric Pain Rating Score (NPRS) <3 in the DPE vs. EPI group.
Time Frame: 1 hour after procedure
The blinded investigator will visit the patient 3 hours within 1hour of block placement and ask to select Numeric Pain Rating Score (NPRS) (1-10) during procedure.The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. EPI group
Time Frame: 1 hour after procedure
The blinded investigator will visit the patient within 1hour of block placement and ask to select Numeric Pain Rating Score (NPRS) (1-10) during procedure. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). Scores range from 0-10 points, with higher scores indicating greater pain intensity.
Secondary Outcomes
- Percent of patients required rescue analgesia in the DPE vs. EPI group(During labor/delivery (up to 24 hours))
- Percent of patients required rescue analgesia in the DPE vs. CSE group(During labor/delivery (up to 24 hours))
Investigators
Dawn Manning-Williams
Assistant Professor
Emory University