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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05068661
Enrollment
101
Registered
2021-10-06
Start date
2021-11-21
Completion date
2023-12-07
Last updated
2024-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labor Pain

Keywords

labor analgesia, neuraxial technique, combined spinal epidural, dural puncture epidural

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.

Interventions

Sponsors

Duke University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
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 hoursThe 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

MeasureTime frameDescription
Number of Participants With Motor Block as Measured by the Modified Bromage ScoreFrom placement of epidural to delivery, up to 32 hoursMotor 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 LaborFrom start of second stage of labor to delivery, up to 6 hoursTime from initiation of pushing to delivery of baby will be recorded
Total Labor Epidural TimeFrom placement of epidural to delivery, up to 32 hoursTime from placement of epidural to delivery will be recorded in anesthetic record
Maternal Adverse EventsFrom placement of epidural to delivery, up to 32 hoursThis will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) BolusesFrom placement of epidural to delivery, up to 32 hours
Mode of DeliveryThrough completion of the study, up to 32 hours from epidural placementSpontaneous and assisted deliveries will be recorded
Postpartum: Satisfaction With Analgesia OverallFrom placement of epidural to delivery, up to 32 hoursPatient satisfaction scores will be recorded from scale of 0 to 10, with 10 being the highest level of satisfaction
Total Anesthetic Dose RequiredFrom placement of epidural to delivery, up to 32 hoursTotal volume of local anesthetic will be recorded.

Countries

United States

Participant flow

Participants by arm

ArmCount
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. Ropivacaine 0.1% Injectable Solution: DPE Bupivacaine 0.25% Injectable Solution: CSE
48
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. Ropivacaine 0.1% Injectable Solution: DPE
52
Total100

Baseline characteristics

CharacteristicCombined Spinal EpiduralTotalDural Puncture Epidural
Age, Continuous31 years
STANDARD_DEVIATION 5
32 years
STANDARD_DEVIATION 4
32 years
STANDARD_DEVIATION 4
Ethnicity (NIH/OMB)
Hispanic or Latino
6 Participants10 Participants4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
41 Participants88 Participants47 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
1 Participants2 Participants1 Participants
Race (NIH/OMB)
American Indian or Alaska Native
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Asian
4 Participants9 Participants5 Participants
Race (NIH/OMB)
Black or African American
9 Participants21 Participants12 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
5 Participants10 Participants5 Participants
Race (NIH/OMB)
White
29 Participants59 Participants30 Participants
Region of Enrollment
United States
48 Participants100 Participants52 Participants
Sex: Female, Male
Female
48 Participants100 Participants52 Participants
Sex: Female, Male
Male
0 Participants0 Participants0 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 480 / 52
other
Total, other adverse events
40 / 4837 / 52
serious
Total, serious adverse events
0 / 480 / 52

Outcome results

Primary

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.

Time frame: From placement of epidural to delivery of baby, up to 32 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Combined Spinal EpiduralNumber of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)16 Participants
Dural Puncture EpiduralNumber of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)13 Participants
p-value: 0.48695% CI: [0.4, 1.39]Chi-squared
Secondary

Duration of the Second Stage of Labor

Time from initiation of pushing to delivery of baby will be recorded

Time frame: From start of second stage of labor to delivery, up to 6 hours

ArmMeasureValue (MEDIAN)
Combined Spinal EpiduralDuration of the Second Stage of Labor23 minutes
Dural Puncture EpiduralDuration of the Second Stage of Labor47 minutes
p-value: 0.12895% CI: [1.14, 3.18]Regression, Linear
Secondary

Maternal Adverse Events

This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH

Time frame: From placement of epidural to delivery, up to 32 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Combined Spinal EpiduralMaternal Adverse Events40 Participants
Dural Puncture EpiduralMaternal Adverse Events37 Participants
p-value: 0.14895% CI: [0.69, 1.06]Chi-squared
Secondary

Mode of Delivery

Spontaneous and assisted deliveries will be recorded

Time frame: Through completion of the study, up to 32 hours from epidural placement

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Combined Spinal EpiduralMode of DeliverySpontaneous Vaginal Delivery32 Participants
Combined Spinal EpiduralMode of DeliveryForceps Assisted Delivery2 Participants
Combined Spinal EpiduralMode of DeliveryVacuum Assisted Delivery1 Participants
Combined Spinal EpiduralMode of DeliveryCesarean Delivery13 Participants
Dural Puncture EpiduralMode of DeliveryCesarean Delivery18 Participants
Dural Puncture EpiduralMode of DeliverySpontaneous Vaginal Delivery33 Participants
Dural Puncture EpiduralMode of DeliveryVacuum Assisted Delivery0 Participants
Dural Puncture EpiduralMode of DeliveryForceps Assisted Delivery1 Participants
p-value: >0.99995% CI: [0.58, 1.24]Chi-squared
Secondary

Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses

Time frame: From placement of epidural to delivery, up to 32 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Combined Spinal EpiduralNumber of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses40 Participants
Dural Puncture EpiduralNumber of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses41 Participants
p-value: >0.99995% CI: [0.52, 1.25]Chi-squared
Secondary

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.

Time frame: From placement of epidural to delivery, up to 32 hours

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Combined Spinal EpiduralNumber of Participants With Motor Block as Measured by the Modified Bromage Score13 Participants
Dural Puncture EpiduralNumber of Participants With Motor Block as Measured by the Modified Bromage Score10 Participants
p-value: >0.99995% CI: [0.98, 1.1]Chi-squared
Secondary

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

Time frame: From placement of epidural to delivery, up to 32 hours

ArmMeasureValue (MEDIAN)
Combined Spinal EpiduralPostpartum: Satisfaction With Analgesia Overall10 score on a scale (0-10)
Dural Puncture EpiduralPostpartum: Satisfaction With Analgesia Overall10 score on a scale (0-10)
p-value: >0.99995% CI: [0.86, 1.22]Regression, Linear
Secondary

Total Anesthetic Dose Required

Total volume of local anesthetic will be recorded.

Time frame: From placement of epidural to delivery, up to 32 hours

ArmMeasureValue (MEDIAN)
Combined Spinal EpiduralTotal Anesthetic Dose Required108 mL
Dural Puncture EpiduralTotal Anesthetic Dose Required108 mL
p-value: >0.99995% CI: [0.93, 1.3]Regression, Linear
Secondary

Total Labor Epidural Time

Time from placement of epidural to delivery will be recorded in anesthetic record

Time frame: From placement of epidural to delivery, up to 32 hours

ArmMeasureValue (MEDIAN)
Combined Spinal EpiduralTotal Labor Epidural Time443 Minutes
Dural Puncture EpiduralTotal Labor Epidural Time534 Minutes
p-value: >0.99995% CI: [0.8, 1.35]Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026