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Study Comparing Dural Puncture Epidural With Epidural and Combined Spinal Epidural Anesthesia for Obstetric Analgesia.

A Double-blind, Randomized, Controlled, Pilot Study Comparing Three Different Anesthesic Techniques for Pregnant Women in Labour: Dural Puncture Epidural, Epidural and Combined Spinal Epidural. Evaluation of the Pain Control and the Hypotension Incidence All Along the Labour and Delivery

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05196256
Enrollment
90
Registered
2022-01-19
Start date
2022-06-30
Completion date
2023-07-30
Last updated
2022-02-24

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

Conditions

Obstetric Pain, Analgesia

Brief summary

This will be a prospective, randomized, double blind, controlled clinical trial. Epidural analgesia (EP) is currently the method of choice to ensure the comfort of the parturient during childbirth. Technical and pharmacological advances in recent years have made it possible to provide patients with high quality analgesia with individualized control, associated with extremely limited motor block. However, sometimes this technique fails due to a prolonged delay in action, or insufficient sensory block. An alternative technique has become popular in recent years, the combined peri-spinal anesthesia also called sequential (CSE). It combines the administration of low doses of local anesthetics and/or intrathecal opiates before the placement of the catheter in the epidural space and the use of the catheter as in a classical technique. This technique would allow a more rapid onset of analgesia, a more complete relief of the patient, and a lower degree of failure. However, it could be accompanied by a greater risk of maternal hemodynamic instability, fetal bradycardia, and a longer expulsion period. In addition, the effectiveness of the catheter injection can only be assessed when the effects of the spinal injected drugs have worn off. In order to limit these undesirable effects, it has been proposed to perform a dural puncture as performed in the sequential technique but without intrathecal drug injection (DPE). In this way, a tunnel is created, allowing the diffusion of drugs from the epidural space to the subarachnoid space. Thus, the initiation of anesthesia would be faster with a lower risk of lateralization compared to the standard epidural, also allowing a decrease in the consumption of local anesthetics and without the undesirable effects of the sequential. Although this technique recently introduced in obstetrical analgesia appears promising, very few studies to date have evaluated its effectiveness and safety. The hypothesis of the study is that the Epidural with Dural puncture (DPE) provides a higher quality of analgesia than standard epidural while having fewer adverse effects than combined epidural, in particular a lower incidence of maternal hypotension. The primary objectives are: * testing the quality of analgesia with DPE compared to PE and CSE. This will be assessed by determining the area under the curve of Visual Analog Scale (VAS) measurements observed from the beginning of obstetric analgesia and throughout the delivery. * testing the rate of maternal hypotension with DPE compared with PE and CSE, with hypotension defined as a decrease in systolic blood pressure (SBP) greater than 15% from the SBP measured at the time of the parturient arrival in the labor room, a SBP \< 90 mmHg, or any decrease in pressure associated with disabling symptomatology (dizziness, yawning, nausea). For this purpose, the investigators will randomize a total of 90 patients, 30 in each of the groups. The patients will receive one of the three techniques, all of them will benefit from the administration of epidural analgesia with low concentration local anesthetics and opioids on a Intermittent bolus modus (PIB). Patients assigned to the combined spinal epidural modus will receive a injection of a small quantity of local anesthetics and opioids (Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg) in the intrathecal space. A non-blinded anesthesiologists will perform the anesthetics technique and leave the room immediately; a blinded anesthesiologists will do the data collection and act according to protocol if the patient in case of pain non controllable by the patient controlled anesthesia, in case of hypotension or any other possible complications. Data collection will take place before starting the locoregional anesthesia technique, at the moment when the anesthetists non blinded leaves the room, 10 minutes, 15 minutes, 30 minutes, 1 hour, 2 hours, 3 hours, 4 hours, 6 hours after the start of the analgesia and at the moment of the expulsion of the baby. Patients and care providers will be blinded to which technic is being given. Data will be statistically analyzed using area under the curve and two-dimension variance analysis.

Interventions

PROCEDUREDural puncture

Dural puncture with a 25 Gauge needle without injection of local anesthetics into the dural space

Standard epidural preceded by a dural puncture with a 25G sequential needle and intrathecal injection of 2.5 ug of Sufentanil and 2.5 mg of normobaric Levobupivacaine

PROCEDUREEpidural analgesia

Epidural analgesia

DRUGSufentanyl/Levobupivacaine

Epidural analgesia

Sponsors

Brugmann University Hospital
Lead SponsorOTHER

Study design

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

Masking description

Patients will be randomized by envelopes. A non-blinded anesthesiologists will perform the anesthetics technique and leave the room immediately; a blinded anesthesiologists will do the data collection and act according to protocol if the patient in case of pain non controllable by the patient controlled anesthesia, in case of hypotension or any other possible complications.

Eligibility

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

Inclusion criteria

* Pregnant women at term (37-42 weeks of amenorrhea) * American Society of Anesthesiologists (ASA) class 1 or 2 * no language barrier, i.e; speaking French, Dutch or English or accompanied by a reliable translator * single pregnancy * Parity 1 , 2 or 3 * cephalic fetal presentation * active labor with cervical dilatation less than 5 cm

Exclusion criteria

* Contraindications to neuraxial anesthesia * major pathologies of pregnancy (preeclampsia) * decompensated gestational diabetes * diabetes type 1 or 2 * known serious fetal pathology * maternal previous diseases increasing the risk of caesarean section (caesarean section, uterine malformation, scarred uterus, surgery of the uterine cervix) * fourth or more deliveries * extreme pre-pregnancy BMI (\< 18 or \> 40)

Design outcomes

Primary

MeasureTime frameDescription
Area under the curve of the pain visual analog scale (VAS)10 minutes after the start of the anesthesia techniqueEvaluation of the quality of analgesia, calculated from the area under the curve of the VAS. The measurements will be performed by a blind team member.
Incidence of maternal hypotension24 hoursTo test whether DPE is accompanied by a lower incidence of maternal hypotension than CSE. For the purposes of this study, hypotension is defined as a decrease of more than 15% in systolic blood pressure (SBP) from the first pressure taken when the patient was admitted to the labor room, SBP \< 90 mm Hg, or any decrease in SBP accompanied by symptomatology (malaise, nausea) requiring rescue treatment. Incidence will be measured as percentage of patients presenting a hypotension according to this definition.

Countries

Belgium

Contacts

Primary ContactDenis Schmartz, MD
denis.schmartz@chu-brugmann.be+3224773996

Outcome results

None listed

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