Epidural Technique: Does it Really Matter to the Patient?

NCT03539796 | Terminated DMC

• 1 other identifier: IRB00098730
• Study Type: interventional
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

dural puncture epidurals; DPE; combined-spinal epidural; CSE; cesarean section; patient satisfaction

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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)

Study Arms (3)

Dural puncture epidurals (DPE)

EXPERIMENTAL

Dural puncture epidurals for cesarean section.

Procedure: Dural puncture epidurals (DPE)

Traditional epidurals (EPI)

ACTIVE COMPARATOR

Traditional epidurals (EPI) for cesarean section.

Procedure: Traditional epidurals (EPI)

Combined-spinal epidural technique (CSE)

ACTIVE COMPARATOR

Combined-spinal epidural technique (CSE) for cesarean section.

Procedure: Combined-spinal epidural technique (CSE)

Interventions

Dural puncture epidurals (DPE) PROCEDURE

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.

Dural puncture epidurals (DPE)

Traditional epidurals (EPI) PROCEDURE

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.

Traditional epidurals (EPI)

Combined-spinal epidural technique (CSE) PROCEDURE

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.

Combined-spinal epidural technique (CSE)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Grady Health System (CRN)

Atlanta, Georgia, 30032, United States

Location

MeSH Terms

Conditions

Patient Satisfaction

Condition Hierarchy (Ancestors)

Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Dawn Manning-Williams, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 16, 2018
• First Posted: May 29, 2018
• Study Start: May 26, 2018
• Primary Completion: July 17, 2022
• Study Completion: July 17, 2022
• Last Updated: January 12, 2023

Record last verified: 2023-01

Locations

US (1)