Epidural Technique: Does it Really Matter to the Patient?

Not Applicable

Terminated

• Conditions: Anesthesia
• Interventions: Procedure: Traditional epidurals (EPI); Procedure: Dural puncture epidurals (DPE); Procedure: Combined-spinal epidural technique (CSE)

• Registration Number: NCT03539796
• Lead Sponsor: Emory University

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-16
• Study First Submitted QC: 2018-05-25
• Study Start: 2018-05-26
• Study First Posted: 2018-05-29
• Primary Completion: 2022-07-17
• Study Completion: 2022-07-17
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-10
• Last Update Posted: 2023-01-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 57

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Traditional epidurals (EPI)	Traditional epidurals (EPI)	Traditional epidurals (EPI) for cesarean section.
Dural puncture epidurals (DPE)	Dural puncture epidurals (DPE)	Dural puncture epidurals for cesarean section.
Combined-spinal epidural technique (CSE)	Combined-spinal epidural technique (CSE)	Combined-spinal epidural technique (CSE) for cesarean section.

Primary Outcome Measures

Name	Time	Method
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group	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.	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	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 Outcome Measures

Name	Time	Method
Percent of patients required rescue analgesia in the DPE vs. EPI group	During labor/delivery (up to 24 hours)	Additional sedation administered during procedure will be documented.
Percent of patients required rescue analgesia in the DPE vs. CSE group	During labor/delivery (up to 24 hours)	Additional sedation administered during procedure will be documented. .

Trial Locations

Locations (1)

Grady Health System (CRN); 🇺🇸 Atlanta, Georgia, United States