Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural

• Conditions: Anesthesia; Analgesia
• Interventions: Procedure: Dural Puncture Epidural (DPE) technique; Procedure: Combined Spinal-Epidural (CSE) technique; Procedure: Epidural

• Registration Number: NCT05514431
• Lead Sponsor: Mayo Clinic

Brief Summary

As the dural puncture epidural (DPE) is increasing in popularity for labor analgesia, it is important to understand how it impacts outcomes in parturients. Prior studies have found epidural catheters placed via the combined-spinal epidural technique have greater success at surgical conversion for cesarean delivery than catheters placed via traditional techniques. The investigators aim to determine if epidural catheters placed by a DPE technique will also have an increased successful conversion for surgical anesthesia by conducting a retrospective review of all CD during the study period. If an association is found, this could be another benefit of DPE for labor analgesia.

Detailed Description

Electronic medical records will be searched for all intrapartum cesarean deliveries performed from February 1, 2017 through May 30, 2021 (Mayo Clinic) and from January 1, 2022 to December 31, 2022 (BC Women's Hospital).

From this list, patients that had cesarean delivery with an epidural catheter will be identified and split into three groups based on the type of neuraxial block listed in the block document of the patient's medical record:

Group 1 - Dural puncture epidural Group 2 - Epidural Group 3 - Combined spinal-epidural

Failure of epidural catheter conversion to surgical anesthesia at cesarean delivery will be defined by requirement of a second anesthetic at the time of surgery, including spinal or repeat epidural techniques or general anesthesia at the time of cesarean delivery

Data Collection: All data will be collected retrospectively from the electronic medical record.

1. Type of neuraxial block

2. Size of needle used for DPE or CSE: 25 g or 27 g

3. Duration of time from epidural placement until CD (Time of epidural placement; time of delivery)

4. Number of epidural top-ups

5. Type and amount of medication used for conversion to surgical anesthesia

6. Urgency of cesarean delivery

7. Airway documentation indicative of general anesthesia (if applicable)

8. Length (time) of surgical procedure

Other data collected from patient electronic records will include:

1. Maternal demographics: Parity, number of prior cesarean deliveries, weight, height, BMI

2. Fetal characteristics (birthweight, Apgar scores)

3. Indication for cesarean delivery

1. Fetal distress (NRFHT, fetal intolerance of labor)

2. Failure of labor (Failure to dilate, failure to descend)

3. Failed operative vaginal delivery

4. Maternal comorbidity

5. Emergency (cord prolapse, abruption, uterine rupture)

4. Anesthesiologist (Fellowship trained: Y/N) at time of cesarean delivery

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2022-08-22
• Study First Submitted QC: 2022-08-22
• Study First Posted: 2022-08-24
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-17
• Last Update Posted: 2024-08-20
• Primary Completion: 2025-07
• Study Completion: 2025-07

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: Female
• Target Recruitment: 1500

Inclusion Criteria

1. Women with neuraxial labor analgesia (CSE, DPE, or Epidural) who have an intrapartum cesarean delivery
2. Singleton gestation

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Exclusion Criteria

1. No local anesthetic given in epidural for cesarean delivery (in emergency situation)
2. Inadvertent dural puncture

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dural puncture epidural (DPE)	Dural Puncture Epidural (DPE) technique	Subjects that received neuraxial labor analgesia of dural puncture epidural for intrapartum cesarean delivery
Combined spinal epidural (CSE)	Combined Spinal-Epidural (CSE) technique	Subjects that received neuraxial labor analgesia of combined spinal epidural for intrapartum cesarean delivery
Traditional Epidural	Epidural	Subjects that received neuraxial labor analgesia of epidural for intrapartum cesarean delivery

Primary Outcome Measures

Name	Time	Method
Conversion to surgical anesthesia	Baseline	Number of subject to have success of conversion to surgical anesthesia for intrapartum cesarean delivery

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

BC Women's Hospital; 🇨🇦 Vancouver, British Columbia, Canada