Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

A Randomized Controlled Trial of Combined Spinal Epidural Versus Dural Puncture Epidural Techniques for Labor Analgesia

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.

Study Overview

• Status: Completed
• Conditions: Labor Pain
• Intervention / Treatment: Drug: Ropivacaine 0.1% Injectable Solution; Drug: Bupivacaine 0.25% Injectable Solution

Detailed Description

This will be a prospective, double-blinded, randomized trial.

Subject identification and recruitment:

Women admitted to the Duke Birthing Center for spontaneous or induced labor will be screened. After usual consultation with the anesthesia team is completed and consent for anesthesia services are obtained, eligible patients will be approached to by a member of the study team. As indicated below, we will plan to enroll up to 120 patients to have 100 patients with complete data (50 for the CSE group and 50 for the DPE group).

Assignment of Study Cohorts:

Study participants will be randomized by computer-generated sequence to CSE or DPE arms, stratified by parity (nulliparous versus multiparous). After the consented and enrolled participant requests labor epidural, a study member will give the anesthesia provider a sealed envelope with study assignment for either standard CSE or DPE technique.

Epidural technique:

Once the patient requests labor analgesia, the usual standard of care for epidural placement will be initiated. The patient will receive 500-1000 mL fluid preload. Vitals will be monitored by the labor nurse, including continuous pulse oximetry, non-invasive blood-pressure monitoring, and external tocodynamometry. Anesthesia time-out will be performed by the anesthesia provider with participation from the nurse and the patient.

All patients will receive a neuraxial technique in the sitting position at L3/4 or L4/5 using loss of resistance to saline. In both the CSE and DPE groups, a 25-G Whitacre needle will be used to puncture the dura. In the CSE group, 10 mcg of preservative-free fentanyl and 2 mg of preservative-free isobaric 0.25% bupivacaine will be administered into the intrathecal space. In both groups, the epidural catheter will be threaded 5 cm into the epidural space. In the DPE group, an initiation dose of 20 mL of ropivacaine 0.1% with fentanyl (2 mcg/mL) over 6 minutes. This would not be administered in the CSE group. Labor analgesia will be maintained by programmed intermittent bolus with 8 mL of the same solution every 45 minutes starting 30 minutes after the initial dose. Patients will have patient-controlled epidural analgesia (PCEA) available with an 10 mL dose per demand, every 10 minutes, for a maximum dose of 50 mL for every hour.

Data Collection:

After the block is placed, a blinded provider will enter the room to collect data. Data will be collected every 3 minutes for the first 30 minutes or until pain score is 1 or 0 with uterine contractions. Subsequent assessments will be every 2 hours until delivery.

Management of breakthrough pain will be standardized.

• Study Type: Interventional
• Enrollment (Actual): 101
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27701
      • Duke University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Combined Spinal Epidural; 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; DPE; Other Names: Fentanyl; Drug: Bupivacaine 0.25% Injectable Solution; CSE; Other Names: Fentanyl; Ropivacaine 0.1% Injectable Solution
Active Comparator: Dural Puncture Epidural; 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; DPE; Other Names: Fentanyl

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maternal Adverse Events	This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH	From placement of epidural to delivery, up to 32 hours
Number of Participants With Motor Block as Measured by the Modified Bromage Score	Motor block is defined as a Bromage score of 1 to 4 on a scale of 1 to 5. 1 = unable flex feet or knees, 2 = able to flex feet only, 3 = able to flex knees, 4 = detectable weakness in hip flexion, 5 = no weakness in hip flexion.	From placement of epidural to delivery, up to 32 hours
Duration of the Second Stage of Labor	Time from initiation of pushing to delivery of baby will be recorded	From start of second stage of labor to delivery, up to 6 hours
Total Labor Epidural Time	Time from placement of epidural to delivery will be recorded in anesthetic record	From placement of epidural to delivery, up to 32 hours
Total Anesthetic Dose Required	Total volume of local anesthetic will be recorded.	From placement of epidural to delivery, up to 32 hours
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses		From placement of epidural to delivery, up to 32 hours
Mode of Delivery	Spontaneous and assisted deliveries will be recorded	Through completion of the study, up to 32 hours from epidural placement
Postpartum: Satisfaction With Analgesia Overall	Patient satisfaction scores will be recorded from scale of 0 to 10, with 10 being the highest level of satisfaction	From placement of epidural to delivery, up to 32 hours

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Ashraf S Habib, MD, Duke University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2021
• Primary Completion (Actual): December 7, 2023
• Study Completion (Actual): December 7, 2023

Study Registration Dates

• First Submitted: September 13, 2021
• First Submitted That Met QC Criteria: September 24, 2021
• First Posted (Actual): October 6, 2021

Study Record Updates

• Last Update Posted (Actual): November 6, 2024
• Last Update Submitted That Met QC Criteria: October 16, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: labor analgesia; combined spinal epidural; neuraxial technique; dural puncture epidural
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Labor Pain; Physiological Effects of Drugs; Peripheral Nervous System Agents; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Sensory System Agents; Analgesics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Anesthetics, Intravenous; Anesthetics, General; Ropivacaine; Bupivacaine; Fentanyl; Pharmaceutical Solutions
• Other Study ID Numbers: Pro00108996

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No