Morbid ObesityPhase 4NCT03074695
DPE Technique in Labor Epidural for Morbidly Obese Women
A Phase 4 study testing Dural puncture epidural (DPE) and Standard Epidural (EPL) in people with Morbid Obesity and Labor Pain, run by Duke University at 1 site in United States.
Trial summary
The primary purpose of this study is to determine differences in block quality between the "dural-puncture epidural" (DPE) and standard epidural (EPL) techniques for labor analgesia in the morbidly obese patient. Read more about this study
- Who is it for?
- Ages 18 to 42 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Morbid Obesity, Labor Pain
- What is being tested?
- Dural puncture epidural (DPE) and Standard Epidural (EPL)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2017to 6 Nov 2020
- 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 42 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Women admitted to the Duke Birthing Center for spontaneous or induced vaginal delivery 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.
- ages 18-45
- singleton
- vertex fetuses at 37-41 weeks' gestation
- nulliparous and multiparous women
- cervical dilation of 2-7cm
Show all 9Show fewer
- BMI ≥ 35 kg/m2,
- pain score > 4
- English-speaking ability.
Who cannot join
- chronic opioid use
- Major cardiac disease
- contraindications to regional anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27701
About this study
Official title: A Randomized Controlled Trial for Epidural Labor Analgesia: Comparison of Dural Puncture Epidural With Standard Labor Epidural Techniques
The primary purpose of this study is to determine differences in block quality between the "dural-puncture epidural" (DPE) and standard epidural (EPL) techniques for labor analgesia in the morbidly obese patient. The investigators hypothesize that when compared to the standard EPL, the DPE technique will improve block quality .
Study participants will be randomized by computer-generated sequence to EPL or DPE arms, stratified by class of obesity (BMI 35-39.9 kg/m2, 40< 50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous versus multiparous). All patients will receive a neuraxial technique in the sitting position at L3/4 or L4/5 using loss of resistance to saline. In the DPE group, a 25-g Whitacre needle will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5 cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl (2 mcg/ml) over 6 minutes as per standard practice. After the initial loading dose and epidural pump is started, the blinded investigator will enter the patient's room to start data collection (time 0). Data will be collected for the first 30 minutes of epidural placement at 3,6,9,12,15,18 21, and 30 minutes to detect the time to achieve target pain ≤ 1/10, then assessed at standardized times (ever 2 hour) until delivery. Breakthrough pain will be managed by a standardized protocol. Other data to be collected will include: catheter adjustments and replacements, physician top-ups, asymmetrical block, pain score, motor block, sensory level to ice, hypotension, total anesthetic dose required, and PCEA use.
Read more
The primary outcome of this study is block quality 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 emergency cesarean section. Secondary outcomes include time to numeric pain rating scale ≤1, maternal adverse events (hypotension, fetal bradycardia, PDPH), motor block, duration of second stage of labor, total labor epidural time, total anesthetic dose required, PCEA use, and mode of delivery.
There is no increased risk/safety issue with placing a dural puncture technique than with epidural for labor analgesia.
Read the detailed description
Purpose of the study:
The primary purpose of this study is to determine if there are differences in block quality between the DPE and standard EPL techniques for labor analgesia in the morbidly obese patient. Establishing superiority of a technique is multifaceted and complex; therefore, the design of the study will define a set of measureable outcomes to assess these properties, which will be addressed in the subsequent sections. The investigators hypothesize that when compared to the standard EPL, the DPE technique will significantly improve block quality in this population.
The secondary purpose of the study is to find an optimal maintenance regimen for epidural analgesia in the morbidly obese population. For the maintenance of epidural analgesia, it is common practice to use either continuous epidural infusion or a programmed intermittent bolus using a solution of ropivicaine 0.1% with fentanyl (2 mcg/mL). To date, there are no randomized prospective studies that investigate maintenance regimens in the morbidly obese parturient population. What has been shown is that super morbidly obese patients have increased intra-abdominal and intracranial pressure which increases pressure in the epidural space. Because of this elevated pressure, the epidural spread is increased, resulting in higher sensory blocks than necessary for adequate labor analgesia.15 An important consequence is that the morbidly obese parturient may experience additional undesirable side effects to a labor epidural: increased respiratory function, increased incidence of hypotension, and increased motor block.
Design and procedures:
The investigators propose a prospective, double-blinded, randomized trial. According to our patient population and incidence of morbid obesity, enrollment would likely occur over a 2 to 3-year period. The investigators have a delivery rate of 3500 per year. Previous data from our institution show that at least 11% of our patients are morbidly obese. The investigators will therefore expect 800-900 morbidly obese women to deliver at our institution per year. The investigators anticipate to complete enrollment for the study in 1-2 years.
Epidural technique:
Once the patient requests a labor epidural, the usual standard of care for epidural placement will be initiated. The patient will have at least one 18g intravenous catheter and will receive 500-1000 milliliter (mL) fluid administration. 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 the DPE group, a 25-g Whitacre needle will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5 cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl (2 mcg/ml) over 6 minutes as per standard practice. Labor analgesia will be maintained by programmed intermittent bolus with 6 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 8 ml dose per demand, every 10 minutes, for a maximum dose of 45 ml for every hour.
Assignment of Study Cohorts:
Study participants will be randomized by computer-generated sequence to EPL or DPE arms, stratified by class of obesity (BMI ≥35<40 kg/m2, ≥40<50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous versus multiparous). Patients will be assigned to one of the four study arms by computer-generated, randomized sequence in order to balance baseline characteristics across the arms. This will be a double-blinded study. After the consented and enrolled participant requests labor epidural, a study member will give the anesthesia provider a sealed envelope with study assignment. The envelope will contain the instructions for placement of epidural with wither standard EPL or DPE technique and specified maintenance regimen of either Programmed Intermittent Epidural Bolus (PIEB) or Continuous Epidural Infusion (CEI).
Protocol for Breakthrough Pain
- If the patient has uneven or unilateral level, the provider will withdrawal catheter 1cm from skin and bolus 5ml of epidural mix. As fetal heart rate allows for maternal repositioning, the patient will lay lateral position with unblocked side in the dependent position. (up to 3 catheter adjustments)
- If the patient has bilateral levels at that below T10 to ice, the patient will be administered 5 ml off epidural pump, up to 3 times in 15 minutes.
- If the patient has pain despite T10 levels, the provider will administer Fentanyl 100 mcg via epidural.
- If analgesia continues despite these interventions up to 3 times within 30-60 minutes, the attending anesthesiologist will determine if epidural catheter needs replacement.
- Conditions
- Morbid Obesity, Labor Pain
- Being tested
- Dural puncture epidural (DPE), Standard Epidural (EPL)
- Medical subject headings
- Obesity, Morbid, Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dural puncture epidural (DPE)Procedure or surgery
Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing
Standard Epidural (EPL)Procedure or surgery
Standard epidural placement
Dural puncture epidural (DPE)Drug
Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
Standard Epidural (EPL)Drug
Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL.
| Study group | Role | What they receive |
|---|---|---|
| Dural Puncture Epidural (DPE) | Experimental | Women who have analgesia initiated with a DPE technique Receives: Procedure: Dural puncture epidural (DPE); Drug: Dural puncture epidural (DPE) |
| Standard Epidural (EPL) | Experimental | Women who have analgesia initiated with an epidural technique Receives: Procedure: Standard Epidural (EPL); Drug: Standard Epidural (EPL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Who Required Asymmetric Block, Top-up Interventions, Catheter Adjustments, Replacement of Epidural Catheter, or Failure of Block Requiring Emergency General Anesthesia or Rescue Neuraxial Prior to Cesarean Delivery
Composite outcome: asymmetric block, top-up interventions required, catheter adjustments, replacement of epidural catheter, or failure or block requiring emergency general anesthesia or rescue neuraxial prior to cesarean delivery
Values shared are indicative of the number of participants who have the one or more of the composite elements for the composite outcome.
Measured: From time of randomization to time of delivery, assessed at standardized times (ever 2 hour) until delivery (estimated 72 hours).
Secondary outcomes (8)
Time to Pain Relief
Time in minutes to numeric pain relief scale <= 1. Less time is better, as the pain relief scale is from 0 - 10, where 10 is the worst imaginable and 0 is no pain.
Measured: Data will be collected for the first 30 minutes of epidural placement to achieve target pain ≤ 1/10
Degree of Motor Block as Measured by the Lowest Bromage Score
The Bromage Score is used to measure degree of motor block, with a range of 1 to 5. A lower score indicates more motor block, so a higher value means a better outcome.
Measured: From time of randomization to time of baby delivery (estimated 72 hours)
Number of Participants With Maternal Adverse Events
Hypotension, fetal bradycardia, post-dural puncture headache
Measured: From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
Duration of Second Stage of Labor
The second stage of labor begins when the cervix is completely dilated and ends with the delivery of the baby.
Measured: From time of randomization to time of baby delivery (estimated 72 hours)
Total Labor Epidural Time
Total labor epidural time
Measured: Total anesthetic time from time of epidural placement until discontinuation (estimated 72 hours)
Total Anesthetic (Ropivacaine 0.1% + Fentanyl 2) Dose Required Per Hour
Consumption of epidural medications in ml including physician boluses, programmed boluses and patient controlled boluses.
Measured: From time of randomization to time of baby delivery (estimated 72 hours)
Mode of Delivery
Spontaneous, assisted, or cesarean delivery
Measured: From time of randomization to time of baby delivery (estimated 72 hours)
Highest Recorded Pain Rating
Numeric pain rating scale (0-10), where higher values indicate more pain or larger change.
Measured: From time of randomization, every 2 hours until time of delivery (estimated 72 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Apr 2017
- Primary completion6 Nov 2020
- Study completion6 Nov 2020
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.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Morbid ObesityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ashraf Habib, Principal investigator, Duke University Hospital Systems
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03074695
- Sponsor's protocol ID
- Pro00079368
- Status last verified
- May 2022
- First submitted
- 16 Feb 2017
- Last updated
- 1 Jun 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vricella LK, Louis JM, Mercer BM, Bolden N. Impact of morbid obesity on epidural anesthesia complications in labor. Am J Obstet Gynecol. 2011 Oct;205(4):370.e1-6. doi: 10.1016/j.ajog.2011.06.085. Epub 2011 Jun 29.
PubMed 21864821Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
PubMed 8267196Collis RE, Davies DW, Aveling W. Randomised comparison of combined spinal-epidural and standard epidural analgesia in labour. Lancet. 1995 Jun 3;345(8962):1413-6. doi: 10.1016/s0140-6736(95)92602-x.
PubMed 7760614Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.
PubMed 18931227Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028.
PubMed 8610864Hess PE, Pratt SD, Lucas TP, Miller CG, Corbett T, Oriol N, Sarna MC. Predictors of breakthrough pain during labor epidural analgesia. Anesth Analg. 2001 Aug;93(2):414-8, 4th contents page. doi: 10.1097/00000539-200108000-00036.
PubMed 11473872Eappen S, Blinn A, Segal S. Incidence of epidural catheter replacement in parturients: a retrospective chart review. Int J Obstet Anesth. 1998 Oct;7(4):220-5. doi: 10.1016/s0959-289x(98)80042-3.
PubMed 15321183Pan PH, Bogard TD, Owen MD. Incidence and characteristics of failures in obstetric neuraxial analgesia and anesthesia: a retrospective analysis of 19,259 deliveries. Int J Obstet Anesth. 2004 Oct;13(4):227-33. doi: 10.1016/j.ijoa.2004.04.008.
PubMed 15477051Roofthooft E. Anesthesia for the morbidly obese parturient. Curr Opin Anaesthesiol. 2009 Jun;22(3):341-6. doi: 10.1097/ACO.0b013e328329a5b8.
PubMed 19412095Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.
PubMed 27100210Gunatilake RP, Smrtka MP, Harris B, Kraus DM, Small MJ, Grotegut CA, Brown HL. Predictors of failed trial of labor among women with an extremely obese body mass index. Am J Obstet Gynecol. 2013 Dec;209(6):562.e1-5. doi: 10.1016/j.ajog.2013.07.023. Epub 2013 Jul 24.
PubMed 23891628
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial for Epidural Labor Analgesia: Comparison of Dural Puncture Epidural With Standard Labor Epidural Techniques
- ClinicalTrials.gov ID
- NCT03074695
- Acronym / sponsor ID
- Pro00079368
- Conditions
- Morbid Obesity, Labor Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 1 Apr 2017 (actual)
- Primary completion
- 6 Nov 2020 (actual)
- Study completion
- 6 Nov 2020 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Posted 1 Jun 2022
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 differences in block quality between the "dural-puncture epidural" (DPE) and standard epidural (EPL) techniques for labor analgesia in the morbidly obese patient. The investigators hypothesize that when compared to the standard EPL, the DPE technique will improve block quality .
Study participants will be randomized by computer-generated sequence to EPL or DPE arms, stratified by class of obesity (BMI 35-39.9 kg/m2, 40< 50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous versus multiparous). All patients will receive a neuraxial technique in the sitting position at L3/4 or L4/5 using loss of resistance to saline. In the DPE group, a 25-g Whitacre needle will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5 cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl (2 mcg/ml) over 6 minutes as per standard practice. After the initial loading dose and epidural pump is started, the blinded investigator will enter the patient's room to start data collection (time 0). Data will be collected for the first 30 minutes of epidural placement at 3,6,9,12,15,18 21, and 30 minutes to detect the time to achieve target pain ≤ 1/10, then assessed at standardized times (ever 2 hour) until delivery. Breakthrough pain will be managed by a standardized protocol. Other data to be collected will include: catheter adjustments and replacements, physician top-ups, asymmetrical block, pain score, motor block, sensory level to ice, hypotension, total anesthetic dose required, and PCEA use.
The primary outcome of this study is block quality 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 emergency cesarean section. Secondary outcomes include time to numeric pain rating scale ≤1, maternal adverse events (hypotension, fetal bradycardia, PDPH), motor block, duration of second stage of labor, total labor epidural time, total anesthetic dose required, PCEA use, and mode of delivery.
There is no increased risk/safety issue with placing a dural puncture technique than with epidural for labor analgesia.
Detailed description
Purpose of the study:
The primary purpose of this study is to determine if there are differences in block quality between the DPE and standard EPL techniques for labor analgesia in the morbidly obese patient. Establishing superiority of a technique is multifaceted and complex; therefore, the design of the study will define a set of measureable outcomes to assess these properties, which will be addressed in the subsequent sections. The investigators hypothesize that when compared to the standard EPL, the DPE technique will significantly improve block quality in this population.
The secondary purpose of the study is to find an optimal maintenance regimen for epidural analgesia in the morbidly obese population. For the maintenance of epidural analgesia, it is common practice to use either continuous epidural infusion or a programmed intermittent bolus using a solution of ropivicaine 0.1% with fentanyl (2 mcg/mL). To date, there are no randomized prospective studies that investigate maintenance regimens in the morbidly obese parturient population. What has been shown is that super morbidly obese patients have increased intra-abdominal and intracranial pressure which increases pressure in the epidural space. Because of this elevated pressure, the epidural spread is increased, resulting in higher sensory blocks than necessary for adequate labor analgesia.15 An important consequence is that the morbidly obese parturient may experience additional undesirable side effects to a labor epidural: increased respiratory function, increased incidence of hypotension, and increased motor block.
Design and procedures:
The investigators propose a prospective, double-blinded, randomized trial. According to our patient population and incidence of morbid obesity, enrollment would likely occur over a 2 to 3-year period. The investigators have a delivery rate of 3500 per year. Previous data from our institution show that at least 11% of our patients are morbidly obese. The investigators will therefore expect 800-900 morbidly obese women to deliver at our institution per year. The investigators anticipate to complete enrollment for the study in 1-2 years.
Epidural technique:
Once the patient requests a labor epidural, the usual standard of care for epidural placement will be initiated. The patient will have at least one 18g intravenous catheter and will receive 500-1000 milliliter (mL) fluid administration. 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 the DPE group, a 25-g Whitacre needle will be used to puncture the dura. In both groups, the epidural catheter will be threaded 5 cm in the epidural space with an initiation dose of 15 ml of ropivacaine 0.1% with fentanyl (2 mcg/ml) over 6 minutes as per standard practice. Labor analgesia will be maintained by programmed intermittent bolus with 6 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 8 ml dose per demand, every 10 minutes, for a maximum dose of 45 ml for every hour.
Assignment of Study Cohorts:
Study participants will be randomized by computer-generated sequence to EPL or DPE arms, stratified by class of obesity (BMI ≥35<40 kg/m2, ≥40<50 kg/m2 and ≥ 50 kg/m2) and by parity (nulliparous versus multiparous). Patients will be assigned to one of the four study arms by computer-generated, randomized sequence in order to balance baseline characteristics across the arms. This will be a double-blinded study. After the consented and enrolled participant requests labor epidural, a study member will give the anesthesia provider a sealed envelope with study assignment. The envelope will contain the instructions for placement of epidural with wither standard EPL or DPE technique and specified maintenance regimen of either Programmed Intermittent Epidural Bolus (PIEB) or Continuous Epidural Infusion (CEI).
Protocol for Breakthrough Pain
- If the patient has uneven or unilateral level, the provider will withdrawal catheter 1cm from skin and bolus 5ml of epidural mix. As fetal heart rate allows for maternal repositioning, the patient will lay lateral position with unblocked side in the dependent position. (up to 3 catheter adjustments)
- If the patient has bilateral levels at that below T10 to ice, the patient will be administered 5 ml off epidural pump, up to 3 times in 15 minutes.
- If the patient has pain despite T10 levels, the provider will administer Fentanyl 100 mcg via epidural.
- If analgesia continues despite these interventions up to 3 times within 30-60 minutes, the attending anesthesiologist will determine if epidural catheter needs replacement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dural Puncture Epidural (DPE) | Experimental | Procedure: Dural puncture epidural (DPE), Drug: Dural puncture epidural (DPE)Women who have analgesia initiated with a DPE technique |
| Standard Epidural (EPL) | Experimental | Procedure: Standard Epidural (EPL), Drug: Standard Epidural (EPL)Women who have analgesia initiated with an epidural technique |
Who may qualify
- Ages
- 18 to 42 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Women admitted to the Duke Birthing Center for spontaneous or induced vaginal delivery 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.
- ages 18-45
- singleton
- vertex fetuses at 37-41 weeks' gestation
- nulliparous and multiparous women
Key exclusion criteria (3 listed)
- chronic opioid use
- Major cardiac disease
- contraindications to regional anesthesia
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 |
|---|---|---|
| Dural puncture epidural (DPE)Epidural with spinal needle placed to confirm cerebral spinal fluid (CSF) position. No intrathecal dosing | Procedure or surgery | Dural Puncture Epidural (DPE) |
| Standard Epidural (EPL)Standard epidural placement | Procedure or surgery | Standard Epidural (EPL) |
| Dural puncture epidural (DPE)Epidural with spinal needle placed to confirm CSF position. No intrathecal dosing. Ropivacaine 0.1% and Fentanyl 2mcg/mL. | Drug | Dural Puncture Epidural (DPE) |
| Standard Epidural (EPL)Standard epidural placement. Ropivacaine 0.1% and Fentanyl 2mcg/mL. | Drug | Standard Epidural (EPL) |
Primary outcome
Number of Participants Who Required Asymmetric Block, Top-up Interventions, Catheter Adjustments, Replacement of Epidural Catheter, or Failure of Block Requiring Emergency General Anesthesia or Rescue Neuraxial Prior to Cesarean Delivery
Time frame: From time of randomization to time of delivery, assessed at standardized times (ever 2 hour) until delivery (estimated 72 hours).
Composite outcome: asymmetric block, top-up interventions required, catheter adjustments, replacement of epidural catheter, or failure or block requiring emergency general anesthesia or rescue neuraxial prior to cesarean delivery Values shared are indicative of the number of participants who have the one or more of the composite elements for the composite outcome.
8 secondary outcomes
Time to Pain Relief
Time frame: Data will be collected for the first 30 minutes of epidural placement to achieve target pain ≤ 1/10
Degree of Motor Block as Measured by the Lowest Bromage Score
Time frame: From time of randomization to time of baby delivery (estimated 72 hours)
Number of Participants With Maternal Adverse Events
Time frame: From time of randomization to time of 24 hours after baby delivery (estimated 72 hours)
Duration of Second Stage of Labor
Time frame: From time of randomization to time of baby delivery (estimated 72 hours)
Total Labor Epidural Time
Time frame: Total anesthetic time from time of epidural placement until discontinuation (estimated 72 hours)
Total Anesthetic (Ropivacaine 0.1% + Fentanyl 2) Dose Required Per Hour
Time frame: From time of randomization to time of baby delivery (estimated 72 hours)
Mode of Delivery
Time frame: From time of randomization to time of baby delivery (estimated 72 hours)
Highest Recorded Pain Rating
Time frame: From time of randomization, every 2 hours until time of delivery (estimated 72 hours)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21864821Vricella LK, Louis JM, Mercer BM, Bolden N. Impact of morbid obesity on epidural anesthesia complications in labor. Am J Obstet Gynecol. 2011 Oct;205(4):370.e1-6. doi: 10.1016/j.ajog.2011.06.085. Epub 2011 Jun 29.
- Background: PubMed 8267196Hood DD, Dewan DM. Anesthetic and obstetric outcome in morbidly obese parturients. Anesthesiology. 1993 Dec;79(6):1210-8. doi: 10.1097/00000542-199312000-00011.
- Background: PubMed 7760614Collis RE, Davies DW, Aveling W. Randomised comparison of combined spinal-epidural and standard epidural analgesia in labour. Lancet. 1995 Jun 3;345(8962):1413-6. doi: 10.1016/s0140-6736(95)92602-x.
- Background: PubMed 18931227Cappiello E, O'Rourke N, Segal S, Tsen LC. A randomized trial of dural puncture epidural technique compared with the standard epidural technique for labor analgesia. Anesth Analg. 2008 Nov;107(5):1646-51. doi: 10.1213/ane.0b013e318184ec14.
- Background: PubMed 8610864Suzuki N, Koganemaru M, Onizuka S, Takasaki M. Dural puncture with a 26-gauge spinal needle affects spread of epidural anesthesia. Anesth Analg. 1996 May;82(5):1040-2. doi: 10.1097/00000539-199605000-00028.
- Background: PubMed 11473872Hess PE, Pratt SD, Lucas TP, Miller CG, Corbett T, Oriol N, Sarna MC. Predictors of breakthrough pain during labor epidural analgesia. Anesth Analg. 2001 Aug;93(2):414-8, 4th contents page. doi: 10.1097/00000539-200108000-00036.
- Background: PubMed 15321183Eappen S, Blinn A, Segal S. Incidence of epidural catheter replacement in parturients: a retrospective chart review. Int J Obstet Anesth. 1998 Oct;7(4):220-5. doi: 10.1016/s0959-289x(98)80042-3.
- Background: PubMed 15477051Pan PH, Bogard TD, Owen MD. Incidence and characteristics of failures in obstetric neuraxial analgesia and anesthesia: a retrospective analysis of 19,259 deliveries. Int J Obstet Anesth. 2004 Oct;13(4):227-33. doi: 10.1016/j.ijoa.2004.04.008.
- Background: PubMed 19412095Roofthooft E. Anesthesia for the morbidly obese parturient. Curr Opin Anaesthesiol. 2009 Jun;22(3):341-6. doi: 10.1097/ACO.0b013e328329a5b8.
- Background: PubMed 27100210Tien M, Allen TK, Mauritz A, Habib AS. A retrospective comparison of programmed intermittent epidural bolus with continuous epidural infusion for maintenance of labor analgesia. Curr Med Res Opin. 2016 Aug;32(8):1435-40. doi: 10.1080/03007995.2016.1181619. Epub 2016 May 20.
- Background: PubMed 23891628Gunatilake RP, Smrtka MP, Harris B, Kraus DM, Small MJ, Grotegut CA, Brown HL. Predictors of failed trial of labor among women with an extremely obese body mass index. Am J Obstet Gynecol. 2013 Dec;209(6):562.e1-5. doi: 10.1016/j.ajog.2013.07.023. Epub 2013 Jul 24.
- Individual participant dataSharing planned: No
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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 Habib principal investigator
Duke University Hospital Systems
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 Dural puncture epidural (DPE) and Standard Epidural (EPL) in people with Morbid Obesity and 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 9 inclusion and 3 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 1 Jun 2022. 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 1 Jun 2022). 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 Who Required Asymmetric Block, Top-up Interventions, Catheter Adjustments, Replacement of Epidural Catheter, or Failure of Block Requiring Emergency General Anesthesia or Rescue Neuraxial Prior to Cesarean Delivery (time frame: From time of randomization to time of delivery, assessed at standardized times (ever 2 hour) until delivery (estimated 72 hours).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03074695, which also lists 11 linked publications.
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 1 Jun 2022.