Labor PainPhase 4NCT05068661
Comparing Effectiveness of CSE Versus DPE for Labor Analgesia
A Phase 4 study testing Ropivacaine 0.1% Injectable Solution and Bupivacaine 0.25% Injectable Solution in people with Labor Pain, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Labor Pain
- What is being tested?
- Ropivacaine 0.1% Injectable Solution and Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 101 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Nov 2021to 7 Dec 2023
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Women with major cardiac disease, chronic pain, chronic opioid use
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27701
About this study
Official title: A Randomized Controlled Trial of Combined Spinal Epidural Versus Dural Puncture Epidural Techniques for Labor Analgesia
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.
Read the 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.
- Conditions
- Labor Pain
- Being tested
- Ropivacaine 0.1% Injectable Solution, Bupivacaine 0.25% Injectable Solution
- Keywords
- labor analgesia, neuraxial technique, combined spinal epidural, dural puncture epidural
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine 0.1% Injectable SolutionDrug
Also called Fentanyl
DPE
Bupivacaine 0.25% Injectable SolutionDrug
Also called Ropivacaine 0.1% Injectable Solution, Fentanyl
CSE
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Ropivacaine 0.1% Injectable Solution; Drug: Bupivacaine 0.25% Injectable Solution |
| 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. Receives: Drug: Ropivacaine 0.1% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From placement of epidural to delivery of baby, up to 32 hours
Secondary outcomes (8)
Maternal Adverse Events
This will include instances such as: hypotension defined as 20% drop in blood pressure from admission blood pressure, fetal bradycardia, PDPH
Measured: From placement of epidural to delivery, up to 32 hours
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.
Measured: 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
Measured: 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
Measured: From placement of epidural to delivery, up to 32 hours
Total Anesthetic Dose Required
Total volume of local anesthetic will be recorded.
Measured: From placement of epidural to delivery, up to 32 hours
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses
Measured: From placement of epidural to delivery, up to 32 hours
Mode of Delivery
Spontaneous and assisted deliveries will be recorded
Measured: 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
Measured: From placement of epidural to delivery, up to 32 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2021
- Study start21 Nov 2021
- Primary completion7 Dec 2023
- Study completion7 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Labor PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 101 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf S Habib, MD, Principal investigator, Duke University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05068661
- Sponsor's protocol ID
- Pro00108996
- Status last verified
- Oct 2024
- First submitted
- 13 Sep 2021
- Last updated
- 6 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Combined Spinal Epidural Versus Dural Puncture Epidural Techniques for Labor Analgesia
- ClinicalTrials.gov ID
- NCT05068661
- Acronym / sponsor ID
- Pro00108996
- Conditions
- Labor Pain
- Keywords
- labor analgesia, neuraxial technique, combined spinal epidural, dural puncture epidural
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 101 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 21 Nov 2021 (actual)
- Primary completion
- 7 Dec 2023 (actual)
- Study completion
- 7 Dec 2023 (actual)
- First posted
- 6 Oct 2021 (actual)
- Results
- Posted 6 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combined Spinal Epidural | Active comparator | Drug: Ropivacaine 0.1% Injectable Solution, Drug: Bupivacaine 0.25% Injectable Solution10 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 | Drug: Ropivacaine 0.1% Injectable SolutionA 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- Women with major cardiac disease, chronic pain, chronic opioid use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ropivacaine 0.1% Injectable SolutionAlso: FentanylDPE | Drug | Combined Spinal Epidural, Dural Puncture Epidural |
| Bupivacaine 0.25% Injectable SolutionAlso: Ropivacaine 0.1% Injectable Solution, FentanylCSE | Drug | Combined Spinal Epidural |
Primary outcome
Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One)
Time frame: 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.
8 secondary outcomes
Maternal Adverse Events
Time frame: From placement of epidural to delivery, up to 32 hours
Number of Participants With Motor Block as Measured by the Modified Bromage Score
Time frame: From placement of epidural to delivery, up to 32 hours
Duration of the Second Stage of Labor
Time frame: From start of second stage of labor to delivery, up to 6 hours
Total Labor Epidural Time
Time frame: From placement of epidural to delivery, up to 32 hours
Total Anesthetic Dose Required
Time frame: From placement of epidural to delivery, up to 32 hours
Number of Participants Who Self-administered PCEA (Patient-controlled Epidural Analgesia) Boluses
Time frame: From placement of epidural to delivery, up to 32 hours
Mode of Delivery
Time frame: Through completion of the study, up to 32 hours from epidural placement
Postpartum: Satisfaction With Analgesia Overall
Time frame: From placement of epidural to delivery, up to 32 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Labor Pain
Not yet recruiting
The 90% Effective Initial Volume for Labor Analgesia Under Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruiting
Initiation Ropivacaine Dose for Labor Analgesia Via Double Dural Puncture Epidural Technique
Labor Pain
Not yet recruitingObservational study
Effect of Dural Puncture Epidural Analgesia on Oxytocin in Early vs Late Labor
Labor Analgesia, Labor Pain
Not yet recruiting
Elevated Midline Positioning During Diaper Change in Preterm Infants
Infant, Premature, Diseases, Premature Birth of Newborn
Not yet recruiting
THE EFFECT OF LISTENING TO SURAH ABESE (VERSES 19-20) DURING CHILDBIRTH ON VAGINAL BIRTH SELF-EFFICACY, BIRTH BELIEFS, AND PAIN PERCEPTION
Labor Pain and to Reduce Pain, Birth Beliefs
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ashraf S Habib, MD principal investigator
Duke University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine 0.1% Injectable Solution and Bupivacaine 0.25% Injectable Solution in people with Labor Pain, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With the Presence of Any of the Five Block Quality Components (or More Than One) (time frame: From placement of epidural to delivery of baby, up to 32 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2024.