Comparing Effectiveness of CSE Versus DPE for Labor Analgesia

Sponsor

Duke University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05068661

Collaborator

(none)

100

Enrollment

Location

Arms

20.3

Anticipated Duration (Months)

4.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Pain	Drug: Ropivacaine 0.1% Injectable Solution Drug: Bupivacaine 0.25% Injectable Solution	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Sequential Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 21, 2021

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Aug 1, 2023

Arms and Interventions

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: Ropivacaine 0.1% Injectable Solution Fentanyl
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

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:

Ropivacaine 0.1% Injectable Solution

Fentanyl

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

Outcome Measures

Primary Outcome Measures

Block quality as defined by a composite of five components [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.

Secondary Outcome Measures

Time to numeric pain rating scale ≤1 [From placement of epidural to 30 minutes later]
After placement and dosing of CSE or DPE, pain scores will be evaluated every 3 minutes for 30 minutes.
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
Incidence of motor block [From placement of epidural to delivery, up to 32 hours]
Motor block assessed by the modified Bromage score will be completed every 2 hours
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 and concentration of local anesthetic will be recorded
PCEA use [From placement of epidural to delivery, up to 32 hours]
The number of demand doses and received doses will be recorded
Mode of delivery [Through completion of the study, up to 32 hours from epidural placement]
Spontaneous and assisted deliveries will be recorded
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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