Epidural Technique: Does it Really Matter to the Patient?

Dural Puncture Epidural Technique vs. Standard Epidurals vs. Combined-Spinal Epidurals for Cesarean Sections: Does it Really Matter to the Patient?

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 Overview

• Status: Terminated
• Conditions: Anesthesia
• Intervention / Treatment: Procedure: Dural puncture epidurals (DPE); Procedure: Traditional epidurals (EPI); Procedure: Combined-spinal epidural technique (CSE)

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 Type: Interventional
• Enrollment (Actual): 57
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Georgia
    • Atlanta, Georgia, United States, 30032
      • Grady Health System (CRN)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dural puncture epidurals (DPE); Dural puncture epidurals for cesarean section.	Procedure: Dural puncture epidurals (DPE); Using the Arrow Epidural Kit (AK-05560) an epidural will be placed using the LOR to saline or air technique. A 26g Gertie Marx needle will be inserted through the Touhy epidural needle and used to puncture the dura; clear, free flowing CSF will return in the needle, but no medications will be injected. The 26g spinal needle will be removed, and the epidural catheter inserted through the epidural needle 3-5cm in the epidural space. A test dose with 3mL 1.5% Lidocaine with 1:200,000 epinephrine will be used to confirm the absence of intrathecal or intravascular catheter placement. The epidural catheter will then be dosed with 0.5% Bupivacaine in 5mL increments until a T4 dermatome level is reached. Epidural fentanyl 100mcg will be administered during initial dosing, and morphine-PF 3mg will be given via epidural after delivery of the fetus.
Active Comparator: Traditional epidurals (EPI); Traditional epidurals (EPI) for cesarean section.	Procedure: Traditional epidurals (EPI); Using the Arrow Epidural Kit (AK-05560) an epidural will be placed using the LOR to saline or air technique. The catheter will be inserted 3-5cm in the epidural space. A test dose with 3mL 1.5% Lidocaine with 1:200,000 epinephrine will be used to confirm the absence of intrathecal or intravascular catheter placement. The epidural catheter will then be dosed with 0.5% Bupivacaine in 5mL increments until a T4 dermatome level is reached. Epidural fentanyl 100mcg will be administered during initial dosing, and morphine-preservative free (PF) 3mg will be given via epidural after delivery of the fetus.
Active Comparator: Combined-spinal epidural technique (CSE); Combined-spinal epidural technique (CSE) for cesarean section.	Procedure: Combined-spinal epidural technique (CSE); Using the Arrow Epidural Kit (AK-05560) an epidural will be placed using the LOR to saline or air technique. A 26g Gertie Marx needle will be inserted through the Touhy epidural needle and used to puncture the dura; clear, free flowing CSF will return in the needle and 12mg bupivacaine, 10mcg fentanyl, 200mcg morphine-PF. The 26g spinal needle will be removed, and the epidural catheter inserted through the epidural needle 3-5cm in the epidural space. No epidural test dose will be given immediately compared to the above procedures secondary to intrathecal injection of local anesthetic with this CSE technique. Only after approximately 1 hour after intrathecal injection will a test dose of 3mL 1.5% Lidocaine with 1:200,000 epinephrine will be used to confirm the absence of intrathecal or intravascular catheter placement. The epidural catheter will then be dosed with 0.5% Bupivacaine for the remainder of the procedure if necessary.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. EPI group	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.	1 hour after procedure
Percent of patients with Numeric Pain Rating Score (NPRS) <3 in the DPE vs. EPI group.	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.	1 hour after procedure
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. CSE group	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.	1 hour after procedure

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Emory University
• Investigators: Principal Investigator: Dawn Manning-Williams, MD, Emory University

Study record dates

Study Major Dates

• Study Start (Actual): May 26, 2018
• Primary Completion (Actual): July 17, 2022
• Study Completion (Actual): July 17, 2022

Study Registration Dates

• First Submitted: May 16, 2018
• First Submitted That Met QC Criteria: May 25, 2018
• First Posted (Actual): May 29, 2018

Study Record Updates

• Last Update Posted (Actual): January 12, 2023
• Last Update Submitted That Met QC Criteria: January 10, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: cesarean section; patient satisfaction; CSE; dural puncture epidurals; DPE; combined-spinal epidural
• Other Study ID Numbers: IRB00098730

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No