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

Sponsor
Mayo Clinic (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT05514431
Collaborator
University of British Columbia (Other)
1,500
2
69.9
750
10.7

Study Details

Study Description

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. We 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Epidural
  • Procedure: Dural Puncture Epidural (DPE) technique
  • Procedure: Combined Spinal-Epidural (CSE) technique

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

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

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

  6. Failed operative vaginal delivery

  7. Maternal comorbidity

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

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

Study Design

Study Type:
Observational
Anticipated Enrollment :
1500 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: Dural Puncture Epidural vs Combined Spinal Epidural vs Epidural
Actual Study Start Date :
Feb 1, 2017
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Dural puncture epidural (DPE)

Subjects that received neuraxial labor analgesia of dural puncture epidural for intrapartum cesarean delivery

Procedure: Dural Puncture Epidural (DPE) technique
Epidural catheters placed via DPE technique

Combined spinal epidural (CSE)

Subjects that received neuraxial labor analgesia of combined spinal epidural for intrapartum cesarean delivery

Procedure: Combined Spinal-Epidural (CSE) technique
Epidural catheters placed via CSE technique

Traditional Epidural

Subjects that received neuraxial labor analgesia of epidural for intrapartum cesarean delivery

Procedure: Epidural
Traditional epidural catheter placement

Outcome Measures

Primary Outcome Measures

  1. Conversion to surgical anesthesia [Baseline]

    Number of subject to have success of conversion to surgical anesthesia for intrapartum cesarean delivery

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  1. Women with neuraxial labor analgesia (CSE, DPE, or Epidural) who have an intrapartum cesarean delivery

  2. Singleton gestation

Exclusion Criteria:
  1. No local anesthetic given in epidural for cesarean delivery (in emergency situation)

  2. Inadvertent dural puncture

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic Rochester Minnesota United States 55902
2 BC Women's Hospital Vancouver British Columbia Canada

Sponsors and Collaborators

  • Mayo Clinic
  • University of British Columbia

Investigators

  • Principal Investigator: Emily Sharpe, MD, Mayo Clinic

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Emily E. Sharpe, M.D., Principal Investigator, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT05514431
Other Study ID Numbers:
  • 20-004677
First Posted:
Aug 24, 2022
Last Update Posted:
Aug 24, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Emily E. Sharpe, M.D., Principal Investigator, Mayo Clinic
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 24, 2022