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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Combined Spinal Epidural | Active Comparator | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine 0.1% Injectable Solution | Drug | DPE |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Women who have a singleton pregancy at 37-41 weeks' gestation
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| Name | Affiliation | Role |
|---|---|---|
| Ashraf S Habib, MD | Duke University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27701 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants who completed the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | From placement of epidural to delivery of baby, up to 32 hours |
|
72 hours
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypotension | Vascular disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ashraf Habib | Duke University School of Medicine | 9196682024 | habib001@mc.duke.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 22, 2024 | Oct 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D048949 | Labor Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D005283 | Fentanyl |
| D002045 | Bupivacaine |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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| Bupivacaine 0.25% Injectable Solution | Drug | CSE |
|
|
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 |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | 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 |
|
|
|
| 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 | Posted | Count of Participants | Participants | From placement of epidural to delivery, up to 32 hours |
|
|
|
|
| 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. | Posted | Count of Participants | Participants | From placement of epidural to delivery, up to 32 hours |
|
|
|
|
| Secondary | Duration of the Second Stage of Labor | Time from initiation of pushing to delivery of baby will be recorded | Posted | Median | Inter-Quartile Range | minutes | From start of second stage of labor to delivery, up to 6 hours |
|
|
|
|
| Secondary | Total Labor Epidural Time | Time from placement of epidural to delivery will be recorded in anesthetic record | Posted | Median | Inter-Quartile Range | Minutes | From placement of epidural to delivery, up to 32 hours |
|
|
|
|
| Secondary | Total Anesthetic Dose Required | Total volume of local anesthetic will be recorded. | Posted | Median | Inter-Quartile Range | mL | From placement of epidural to delivery, up to 32 hours |
|
|
|
|
| Secondary | Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses | Posted | Count of Participants | Participants | From placement of epidural to delivery, up to 32 hours |
|
|
|
|
| Secondary | Mode of Delivery | Spontaneous and assisted deliveries will be recorded | Posted | Count of Participants | Participants | Through completion of the study, up to 32 hours from epidural placement |
|
|
|
|
| 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 | Posted | Median | Inter-Quartile Range | score on a scale (0-10) | From placement of epidural to delivery, up to 32 hours |
|
|
|
|
| 0 |
| 48 |
| 0 |
| 48 |
| 40 |
| 48 |
| EG001 | 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 | 0 | 52 | 0 | 52 | 37 | 52 |
| Pruritus | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Postdural Puncture Headache | Nervous system disorders | Systematic Assessment |
|
| Fetal Heart Rate decelerations | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
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| D000588 |
| Amines |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| Vacuum Assisted Delivery |
|
| Cesarean Delivery |
|