AnesthesiaNCT03539796
Epidural Technique: Does it Really Matter to the Patient?
A study testing Dural puncture epidurals (DPE), Traditional epidurals (EPI) and Combined-spinal epidural technique (CSE) in people with Anesthesia, run by Emory University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Anesthesia
- What is being tested?
- Dural puncture epidurals (DPE), Traditional epidurals (EPI) and Combined-spinal epidural technique (CSE)
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteUnited States
- Study dates
- 26 May 2018to 17 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Anesthesia
- Being tested
- Dural puncture epidurals (DPE), Traditional epidurals (EPI), Combined-spinal epidural technique (CSE)
- Keywords
- dural puncture epidurals, DPE, combined-spinal epidural, CSE, cesarean section, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural puncture epidurals (DPE)Procedure or surgery
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.
Traditional epidurals (EPI)Procedure or surgery
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.
Combined-spinal epidural technique (CSE)Procedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Dural puncture epidurals (DPE) | Experimental | Dural puncture epidurals for cesarean section. Receives: Procedure: Dural puncture epidurals (DPE) |
| Traditional epidurals (EPI) | Active comparator | Traditional epidurals (EPI) for cesarean section. Receives: Procedure: Traditional epidurals (EPI) |
| Combined-spinal epidural technique (CSE) | Active comparator | Combined-spinal epidural technique (CSE) for cesarean section. Receives: Procedure: Combined-spinal epidural technique (CSE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 1 hour after procedure
Secondary outcomes (2)
Percent of patients required rescue analgesia in the DPE vs. EPI group
Additional sedation administered during procedure will be documented.
Measured: 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. .
Measured: During labor/delivery (up to 24 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2018
- Study start26 May 2018
- Primary completion17 Jul 2022
- Study completion17 Jul 2022
Why it stopped: This study was terminated early because of shortage of supplies with no foreseeable future of when they will be back in stock.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnesthesiaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dawn Manning-Williams, Emory University
- Investigators
- Dawn Manning-Williams, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03539796
- Sponsor's protocol ID
- IRB00098730
- Status last verified
- Jan 2023
- First submitted
- 16 May 2018
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dural Puncture Epidural Technique vs. Standard Epidurals vs. Combined-Spinal Epidurals for Cesarean Sections: Does it Really Matter to the Patient?
- ClinicalTrials.gov ID
- NCT03539796
- Acronym / sponsor ID
- IRB00098730
- Conditions
- Anesthesia
- Keywords
- dural puncture epidurals, DPE, combined-spinal epidural, CSE, cesarean section, patient satisfaction
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated early because of shortage of supplies with no foreseeable future of when they will be back in stock.
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- 26 May 2018 (actual)
- Primary completion
- 17 Jul 2022 (actual)
- Study completion
- 17 Jul 2022 (actual)
- First posted
- 29 May 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dural puncture epidurals (DPE) | Experimental | Procedure: Dural puncture epidurals (DPE)Dural puncture epidurals for cesarean section. |
| Traditional epidurals (EPI) | Active comparator | Procedure: Traditional epidurals (EPI)Traditional epidurals (EPI) for cesarean section. |
| Combined-spinal epidural technique (CSE) | Active comparator | Procedure: Combined-spinal epidural technique (CSE)Combined-spinal epidural technique (CSE) for cesarean section. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Procedure or surgery | Dural puncture epidurals (DPE) |
| 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. | Procedure or surgery | Traditional epidurals (EPI) |
| 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. | Procedure or surgery | Combined-spinal epidural technique (CSE) |
Primary outcome
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.
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. 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.
2 secondary outcomes
Percent of patients required rescue analgesia in the DPE vs. EPI group
Time frame: During labor/delivery (up to 24 hours)
Percent of patients required rescue analgesia in the DPE vs. CSE group
Time frame: During labor/delivery (up to 24 hours)
Results and safety
The study was stopped early (reason given: This study was terminated early because of shortage of supplies with no foreseeable future of when they will be back in stock.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dawn Manning-Williams, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dural puncture epidurals (DPE), Traditional epidurals (EPI) and Combined-spinal epidural technique (CSE) in people with Anesthesia, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: This study was terminated early because of shortage of supplies with no foreseeable future of when they will be back in stock.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of patients with Numeric Pain Rating Score (NPRS)<1 in the DPE vs. EPI group (time frame: 1 hour after procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2023; AzTrials last refreshed its copy on 31 Oct 2026.