Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Phase 4

Completed

• Conditions: Labor Pain
• Interventions: Drug: Ropivacaine 0.1% Injectable Solution; Drug: Bupivacaine 0.25% Injectable Solution

• Registration Number: NCT05068661
• Lead Sponsor: Duke University

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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-09-13
• Study First Submitted QC: 2021-09-24
• Study First Posted: 2021-10-06
• Study Start: 2021-11-21
• Primary Completion: 2023-12-07
• Study Completion: 2023-12-07
• Status Verified: 2024-10
• Results First Submitted: 2024-10-16
• Results First Submitted QC: 2024-10-16
• Last Update Submitted: 2024-10-16
• Results First Posted: 2024-11-06
• Last Update Posted: 2024-11-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 101

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

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Combined Spinal Epidural	Ropivacaine 0.1% Injectable Solution	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.
Combined Spinal Epidural	Bupivacaine 0.25% Injectable Solution	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.
Dural Puncture Epidural	Ropivacaine 0.1% Injectable Solution	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)	From placement of epidural to delivery of baby, up to 32 hours	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.

Secondary Outcome Measures

Name	Time	Method
Maternal Adverse Events	From placement of epidural to delivery, up to 32 hours	This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH
Number of Participants With Motor Block as Measured by the Modified Bromage Score	From placement of epidural to delivery, up to 32 hours	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.
Duration of the Second Stage of Labor	From start of second stage of labor to delivery, up to 6 hours	Time from initiation of pushing to delivery of baby will be recorded
Total Labor Epidural Time	From placement of epidural to delivery, up to 32 hours	Time from placement of epidural to delivery will be recorded in anesthetic record
Total Anesthetic Dose Required	From placement of epidural to delivery, up to 32 hours	Total volume of local anesthetic will be recorded.
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses	From placement of epidural to delivery, up to 32 hours
Postpartum: Satisfaction With Analgesia Overall	From placement of epidural to delivery, up to 32 hours	Patient satisfaction scores will be recorded from scale of 0 to 10, with 10 being the highest level of satisfaction
Mode of Delivery	Through completion of the study, up to 32 hours from epidural placement	Spontaneous and assisted deliveries will be recorded

Trial Locations

Locations (1)

Duke University Hospital; 🇺🇸 Durham, North Carolina, United States