Clinical trial NCT05514431: Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: DPE v CSE v Epidural
Official title: Conversion of Labor Analgesia for Intrapartum Cesarean Delivery: Dural Puncture Epidural vs Combined Spinal Epidural vs Epidural
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Anesthesia
Analgesia
Keywords: epidural
cesarean
parturient
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: University of British Columbia
First posted: 2022-08-24
Enrollment: 1500
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Parturients that undergo intrapartum cesarean delivery with an epidural already in situ.

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

Eligibility criteria: 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

Primary outcomes:
measure: Conversion to surgical anesthesia
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Vancouver
country: Canada
facility: BC Women's Hospital
state: British Columbia
Study officials:
affiliation: Mayo Clinic
name: Emily Sharpe, MD
role: PRINCIPAL_INVESTIGATOR
References: