Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

NCT05068661 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: Pro00108996
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

Brief Summary

The primary purpose of this study is to determine if there are differences in block quality between the CSE and DPE techniques for labor analgesia in parturients in active labor. We hypothesize that when compared to the CSE technique, the DPE technique will significantly improve block quality in this population and require fewer "top-ups" and catheter replacements.

Conditions

Labor Pain

Keywords

labor analgesia; neuraxial technique; combined spinal epidural; dural puncture epidural

Outcome Measures

Primary Outcomes (1)

• Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)

  The primary outcome of this study is block quality which will be defined by a composite of five components (1) asymmetric block after 30 minutes of initiation, (2) top-up interventions, (3) catheter adjustments (4) failed catheter requiring replacement, and (5) failed epidural requiring general anesthesia or replacement neuraxial anesthesia for cesarean section. The presence of any of the components (or more than one) indicates that the outcome occurred.

  From placement of epidural to delivery of baby, up to 32 hours

Secondary Outcomes (8)

• Maternal Adverse Events

  From placement of epidural to delivery, up to 32 hours

• Number of Participants With Motor Block as Measured by the Modified Bromage Score

  From placement of epidural to delivery, up to 32 hours

• Duration of the Second Stage of Labor

  From start of second stage of labor to delivery, up to 6 hours

• Total Labor Epidural Time

  From placement of epidural to delivery, up to 32 hours

• Total Anesthetic Dose Required

  From placement of epidural to delivery, up to 32 hours

Study Arms (2)

Combined Spinal Epidural

ACTIVE COMPARATOR

10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space to initiate analgesia. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.

Drug: Ropivacaine 0.1% Injectable Solution; Drug: Bupivacaine 0.25% Injectable Solution

Dural Puncture Epidural

ACTIVE COMPARATOR

A 25-G Whitacre needle will be used to puncture the dura. An initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) will be administered. Labor analgesia will be maintained by programmed intermittent bolus with patient-controlled epidural analgesia (PCEA) as per standard of care.

Drug: Ropivacaine 0.1% Injectable Solution

Interventions

Ropivacaine 0.1% Injectable Solution DRUG

DPE

Also known as: Fentanyl

Combined Spinal Epidural; Dural Puncture Epidural

Bupivacaine 0.25% Injectable Solution DRUG

CSE

Also known as: Ropivacaine 0.1% Injectable Solution, Fentanyl

Combined Spinal Epidural

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: Women who have a singleton pregancy at 37-41 weeks' gestation
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Ages 18-45, singleton, vertex fetuses at 37-41 weeks' gestation, nulliparous and multiparous women, cervical dilation of 2-7cm, pain score \> 4, and English-speaking ability

You may not qualify if:

• Women with major cardiac disease, chronic pain, chronic opioid use

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Hospital

Durham, North Carolina, 27701, United States

Location

MeSH Terms

Conditions

Labor Pain

Interventions

Ropivacaine; Fentanyl; Bupivacaine

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Ashraf Habib
• Organization: Duke University School of Medicine

habib001@mc.duke.edu

9196682024

Study Officials

• Ashraf S Habib, MD

  Duke University Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2021
• First Posted: October 6, 2021
• Study Start: November 21, 2021
• Primary Completion: December 7, 2023
• Study Completion: December 7, 2023
• Last Updated: November 6, 2024
• Results First Posted: November 6, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)