- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04728048
Dural Puncture Epidural VS Standard Epidural on Physician Top-ups During Labour Analgesia (DPE)
A Randomized Clinical Study to Compare the Number of Physician Top-up Interventions During the First Stage of Labour Between Two Different Neuraxial Analgesia Techniques: the Dural Puncture Epidural and the Standard Epidural
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Providing adequate labour analgesia has always been an important issue in obstetrical anesthesia. Different types of neuraxial techniques include standard epidural analgesia (EPL), combined spinal epidural analgesia (CSE) and dural puncture epidural analgesia (DPE). DPE, which has gained in popularity in recent years, is similar to CSE in which the dura mater is punctured, however without injection of medication in the cerebrospinal fluid (CSF). Recent studies have found benefits of the DPE technique, such as less fetal bradycardia than CSE, better bilateral sacral analgesia than EPL and faster onset than EPL. No study has yet compared DPE to EPL when an ultra-low concentration of local anesthetic protocol is used for maintenance of analgesia. We hypothesize that in term primiparous and multiparous parturients, a dural puncture epidural technique will improve labour analgesia quality during the first stage of labour (based on physician top-up interventions) compared with a standard epidural technique when a patient-controlled epidural analgesia (PCEA) with ultra-low concentration epidural mixture classically used in our institution based on our hospital orders and national guidelines.
The main hypothesis for this study is to show that there will be 50% reduction in the incidence of parturients in need of at least one physician top-up intervention during the first stage of labour in the DPE group compared to the EPL group.
The patients will be approached by the anesthesia research team upon arrival at the birth unit. The randomization will be done at the time the parturient requests an epidural. Randomization will be done in a 1:1 ratio until we reach 65 subjects in each group.
Before neuraxial catheter placement, a 20G or 18G intravenous (IV) catheter is inserted and standard monitoring is applied.
The attending or resident in anesthesiology will place the neuraxial catheter following the next steps :
- Epidural space is identified in seated position (L2-L3 or L3-L4) using an epidural needle 17G 10 cm Tuohy.
- Loss of resistance to saline technique.
- In both groups, a needle-through-needle technique is performed using a 25G 5-inch Whitacre spinal needle.
- In group DPE, a single dural puncture with confirmation of free-flow CSF is performed and in group EPL no dural puncture is performed.
- Catheter is placed 4-5 cm in the epidural space: 19G multi-orifice Perifix FX catheter.
Initiation of analgesia in both groups will be as followed :
- Test dose of 3mL bupivacaine 0,25%.
- Initial bolus (10mL Bupivacaine 0,125% plus fentanyl 50mcg) fractioned in two doses.
- PCEA is then initiated with a basal infusion of 6mL/h (solution of bupivacaine 0,0625% + fentanyl 2mcg/mL) and 8 mL boluses are permitted every 20 minutes.
If analgesia is inadequate, defined as NPRS ≥ 4, within the first 30 minutes of epidural initiation OR more than 30 minutes after catheter placement and after 2 PCEA boluses in less than 1 hour, the initial step will be to administered a nurse top-up intervention: 10 mL bolus of the epidural infusion (bupivacaine 0,0625% + fentanyl 2mcg/mL) via the infusion pump. If analgesia is still inadequate 30 minutes after initial nurse top-up intervention, the anesthesiologist is called, the catheter is pulled back 1cm and a physician manual top-up 10mL bolus of bupivacaine 0,125% is administered. If 30 minutes after the physician manual top-up bolus analgesia is still inadequate, analgesia management is transferred to the attending anesthesiologist.
Standard nurse care during and after catheter placement will be applied following an already established protocol at our center.
Analgesia will be evaluated using the verbal NPRS from Gélinas C. (2007) that allows parturients to rate their pain on a scale from 0 to 10. Sensory blockade will be evaluated using ice. The evaluation will start at the S2 dermatome, where S2 is assessed at the midpoint of the popliteal fossa, and will be moving in a caudad to cephalad direction. The evaluator will assess asymmetrical blockade, which is defined as a difference in sensory blockade to cold sensation greater than 2 dermatomal levels between the left and right side of the patient. Motor blockade will be evaluated using the Bromage score (1978).
Ambulation criteria will be evaluated at certain times following initial physician bolus. The criteria already established in our center are listed below:
- No obstetrical contraindications.
- Sensory blockade ≤ T4.
- Absence of motor blockade according to Bromage score (score = 4).
- Systolic blood pressure ≥ 90 mmHg AND/OR a fall of less than 20 mmHg compared to the patient's initial systolic blood pressure.
- Negative postural hypotension test.
- Successful squat test.
Parturients overall satisfaction with neuraxial analgesia will be evaluated the day following delivery. Presence or absence of post dural puncture headache symptoms will be noted at 24h post partum.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Christian Loubert
- Phone Number: 5145677340
- Email: christian.loubert@umontreal.ca
Study Contact Backup
- Name: Nadia Godin
- Phone Number: 3193 514-252-3400
- Email: ngodin.hmr@ssss.gouv.qc.ca
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H1T2M4
- Recruiting
- CIUSSS de l'Est de l'Ile de Montréal
-
Contact:
- Christian Loubert
- Phone Number: 1-514-567-7340
- Email: loubertch@yahoo.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy pregnant women (ASA 1 and 2) requesting epidural analgesia during labour.
- Primiparous and multiparous parturients at term gestation (37 to 42 weeks).
- Women 18 years old and older.
- Administration of epidural analgesia between 7am and 4pm on weekdays.
- Singleton and vertex presentation foetus.
- Cervical dilatation ≤ 5 cm.
- BMI ≤ 40.
- French speaking
Exclusion Criteria:
- Pregnancy diseases such as gestational hypertension, preeclampsia and gestational diabetes.
- Contraindications to neuraxial analgesia: thrombocytopenia < 70 x 109/L, spinal cord anomalies, anticoagulation therapy, etc.
- Known important fetal anomalies.
- Allergy to any of the medications used in the study.
- Suspected chorioamnionitis with spontaneous premature rupture of membranes (PROM).
- Difficulty understanding and speaking French.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Dural puncture epidural (group DPE)
The epidural space will be identified in the seated position between the L2 and L5 interspaces with a 17G-10 cm Tuohy epidural needle (CHS ®, Oakville, ON, Canada) using a loss of resistance to saline technique.
In both groups, a needle-through-needle technique will be performed using a 25G 5-inch Whitacre spinal needle (BD®, Franklin Lakes, NJ, USA).
In group DPE, a single dural puncture with confirmation of free-flow CSF will be performed.
If there is no free-flow CSF return through the spinal needle, the epidural catheter will be threaded 4-5cm in the epidural space and the patient will still be assigned to the DPE group, as per "intent-to-treat" protocol.
|
already described
|
Active Comparator: Standard epidural (group EPL)
The epidural space will be identified in the seated position between the L2 and L5 interspaces with a 17G-10 cm Tuohy epidural needle (CHS ®, Oakville, ON, Canada) using a loss of resistance to saline technique.
In both groups, a needle-through-needle technique will be performed using a 25G 5-inch Whitacre spinal needle (BD®, Franklin Lakes, NJ, USA).In Group EPL, no dural puncture will be performed and the catheter will be threaded 4-5cm in the epidural space.
|
already described
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Need for 1 physician epidural top-up
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
The number of parturients who need at least one physician top-up intervention during the first stage of labour.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of physician epidural top-ups
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To compare the number of physician top-up interventions necessary in the first stage of labour between both groups.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Timing of physician top-ups
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To measure the timing of request for physician top-up interventions and timing of actual physician top-up interventions.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Analgesia scores
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To evaluate the analgesia, using the verbal numeric pain rating scale (NPRS) from 0 to 10, every 5 minutes after catheter placement until NPRS ≤ 3, and then every hour.
Each time, the parturient will evaluate her maximal pain during the last contraction.
If the parturient is sleeping and does not wake up in the 30 minutes following the planned analgesia evaluation, we will respect sleep and consider that the analgesia is adequate at that time and will be scored at 0 on the NPRS.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Sacral block
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To assess the incidence of S2 bilateral blockade every hour, where S2 is assessed at the midpoint of the popliteal fossa.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Asymetrical block
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To assess the incidence of asymmetrical blockade every hour, which is defined as a difference in sensory blockade to cold sensation greater than 2 dermatomal levels between the left and right sides of the patient.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Motor block
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To assess the presence of motor blockade every hour, using the Bromage score (1 to 4).
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Ambulation criteria
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To determine the number of parturients that fulfill ambulation criteria at 30 min, 1 hour and 2 hours after catheter placement.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Ambulation
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To determine the number of parturients that ambulate at any moment during the first stage of labour.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Urinary catheterisation
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To determine the number of parturients who need urinary catheterisation for any indication.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Local anesthetic and fentanyl doses
Time Frame: Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
To determine the total quantity of local anesthetic (mg) and fentanyl (mcg) that are received during the first stage labour in both groups, including the top-up boluses.
|
Up to 24 hours after inclusion. From installation of epidural analgesia until the end of first stage of labour defined as full cervix dilation or decision by the attending obstetrician to proceed to a cesarean delivery.
|
Patient satisfaction
Time Frame: Up to 48 hours after inclusion.
|
To evaluate the parturients overall satisfaction with neuraxial analgesia 24 hours postpartum, using a 0 to 100 scale.
A cutoff of ≤ 60 will be taken as poor satisfaction.
|
Up to 48 hours after inclusion.
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-2334
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Labor Pain
-
Cukurova UniversityRecruitingLabor Pain, Labor Perception, Hormone Levels and Childbirth ComfortTurkey
-
Soovu Labs Inc.Virginia Mason Hospital/Medical CenterNot yet recruiting
-
Bogomolets National Medical UniversityCompleted
-
Martin-Luther-Universität Halle-WittenbergRecruiting
-
Maimonides Medical CenterTerminated
-
Aretaieio HospitalRecruitingLabor Pain | Pain, Labor | EpiduralGreece
-
Mashhad University of Medical SciencesTerminatedDecrease Labor Pain
-
Amasya UniversityAtaturk UniversityNot yet recruitingSatisfaction, Patient | Pain, Labor
-
University Medical Centre LjubljanaCompletedLabor Pain | Labor; Prolonged, First Stage | Labor; Prolonged, Second StageSlovenia
Clinical Trials on Dural puncture epidural
-
Medical University of South CarolinaCompletedLabor Pain | Labor AnalgesiaUnited States
-
National Research Centre, EgyptCairo UniversityWithdrawnDural Puncture Epidural Technique
-
Cairo UniversityActive, not recruitingDural Puncture Epidural TechniqueEgypt
-
Mayo ClinicUniversity of British ColumbiaEnrolling by invitationAnalgesia | AnesthesiaUnited States, Canada
-
Cairo UniversityCompletedGynecologic Disease Requiring Vaginal Operation Under Neuraxial AnesthesiaEgypt
-
Zongxun LinRecruiting
-
Ataturk UniversityNot yet recruiting
-
University of ChileCompletedEpidural Analgesia | Labor PainChile
-
Ain Shams UniversityCompleted
-
Reham Ali Abdelhaleem AbdelrahmanCompleted