Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Epidural Technique: Does it Really Matter to the Patient?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03539796
Recruitment Status : Recruiting
First Posted : May 29, 2018
Last Update Posted : January 24, 2022
Sponsor:
Information provided by (Responsible Party):
Dawn Manning-Williams, Emory University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Anesthesia Procedure: Dural puncture epidurals (DPE) Procedure: Traditional epidurals (EPI) Procedure: Combined-spinal epidural technique (CSE) Not Applicable

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Dural Puncture Epidural Technique vs. Standard Epidurals vs. Combined-Spinal Epidurals for Cesarean Sections: Does it Really Matter to the Patient?
Actual Study Start Date : May 26, 2018
Estimated Primary Completion Date : November 2022
Estimated Study Completion Date : November 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Percent of patients required rescue analgesia in the DPE vs. EPI group [ Time Frame: During labor/delivery (up to 24 hours) ]
    Additional sedation administered during procedure will be documented.

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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03539796


Contacts
Layout table for location contacts
Contact: Dawn Manning-Williams, MD (404) 616-6051 dmannin@emory.edu

Locations
Layout table for location information
United States, Georgia
Grady Health System (CRN) Recruiting
Atlanta, Georgia, United States, 30032
Contact: Dawn Manning-Williams, MD    404-616-6051    dmannin@emory.edu   
Sponsors and Collaborators
Emory University
Investigators
Layout table for investigator information
Principal Investigator: Dawn Manning-Williams, MD Emory University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Dawn Manning-Williams, Assistant Professor, Emory University
ClinicalTrials.gov Identifier: NCT03539796    
Other Study ID Numbers: IRB00098730
First Posted: May 29, 2018    Key Record Dates
Last Update Posted: January 24, 2022
Last Verified: January 2022

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dawn Manning-Williams, Emory University:
dural puncture epidurals
DPE
combined-spinal epidural
 CSE
cesarean section
patient satisfaction