Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Labor Pain

Intervention / Treatment
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* Drug: Ropivacaine 0.1% Injectable Solution
* Drug: Bupivacaine 0.25% Injectable Solution


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Combined Spinal Epidural<br>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<br>* DPE<br>* Other names: Fentanyl;Drug: Bupivacaine 0.25% Injectable Solution<br>* CSE<br>* Other names: Fentanyl;|
| Active Comparator: Dural Puncture Epidural<br>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<br>* DPE<br>* Other names: Fentanyl;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Block quality as defined by a composite of five components | 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. | From placement of epidural to delivery of baby, up to 32 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to numeric pain rating scale ≤1 | After placement and dosing of CSE or DPE, pain scores will be evaluated every 3 minutes for 30 minutes. | From placement of epidural to 30 minutes later | 
| 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 | 
| Incidence of motor block | Motor block assessed by the modified Bromage score will be completed every 2 hours | 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 and concentration of local anesthetic will be recorded | From placement of epidural to delivery, up to 32 hours | 
| PCEA use | The number of demand doses and received doses will be recorded | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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labor analgesia, neuraxial technique, combined spinal epidural, dural puncture epidural