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

February 23, 2022 updated by: Denis SCHMARTZ, Brugmann University Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1020
        • CHU Brugmann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dural Puncture Epidural group (DPE)
Dural puncture with a 25 Gauge needle, then placement of the epidural catheter (Tuohy 18 Gauge). The medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL, both administered epidurally with a programmed intermittent bolus mode (PIB) and patient controlled epidural analgesia (PCEA). An initial fractionated bolus of 20 mL will be administered epidurally, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40min. PCEA pump will allow 10 mL every 20 min, all along the dilatation and expulsion period.
Procedure: Dural puncture
Dural puncture with a 25 Gauge needle without injection of local anesthetics into the dural space
Drug: Sufentanyl/Levobupivacaine
Epidural analgesia
ACTIVE_COMPARATOR: Epidural group (EP)
Placement of an epidural catheter through a 18 Gauge Tuohy needle. The medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL, both administered epidurally with a programmed intermittent boluses mode (PIB) and patient controlled epidural analgesia (PCEA); An initial fraction bolus of 20ml will be administered epidurally, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40 min. PCEA pump will allow 10 mL every 20 min, all along the dilatation and expulsion period.
Drug: Sufentanyl/Levobupivacaine
Epidural analgesia
Procedure: Epidural analgesia
Epidural analgesia
ACTIVE_COMPARATOR: Combined Spinal-Epidural group (CSE)
Spinal injection through a 25 Gauge needle of Levobupivacaine 2.5mg and Sufentanyl 2.5 mcg in a total volume of 2 mL, placing an epidural catheter through a Tuohy 18 Gauge needle. The epidural medication consists of Levobupivacaine 0.0625% and Sufentanyl 0.25 mcg/mL. The epidural medication is administered on a programmed intermittent bolus mode (PIB) and patient controlled epidural analgesia (PCEA). An initial fractioned bolus of 20 mL will be administered epidurally 30 min after the intrathecal injection, then automatic intermittent bolus of 10 mL will be administered, the first one after 30 min and then every 40 min. PCEA pump will allow 10 mL every 20min, all along the dilatation and expulsion period.
Drug: Sufentanyl/Levobupivacaine
Epidural analgesia
Procedure: Combined spinal epidural analgesia
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 10 minutes after the start of the anesthesia technique
Evaluation 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.
10 minutes after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 15 minutes after the start of the anesthesia technique
Evaluation 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.
15 minutes after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 30 minutes after the start of the anesthesia technique
Evaluation 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.
30 minutes after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 1 hour after the start of the anesthesia technique
Evaluation 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.
1 hour after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 2 hours after the start of the anesthesia technique
Evaluation 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.
2 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 3 hours after the start of the anesthesia technique
Evaluation 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.
3 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 4 hours after the start of the anesthesia technique
Evaluation 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.
4 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: 6 hours after the start of the anesthesia technique
Evaluation 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.
6 hours after the start of the anesthesia technique
Area under the curve of the pain visual analog scale (VAS)
Time Frame: From the start of the anesthesia technique until delivery of the baby (max up to 24 hours)
Evaluation 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.
From the start of the anesthesia technique until delivery of the baby (max up to 24 hours)
Incidence of maternal hypotension
Time Frame: 24 hours
To 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.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brugmann University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 30, 2022

Primary Completion (ANTICIPATED)

June 30, 2023

Study Completion (ANTICIPATED)

July 30, 2023

Study Registration Dates

First Submitted

December 30, 2021

First Submitted That Met QC Criteria

January 18, 2022

First Posted (ACTUAL)

January 19, 2022

Study Record Updates

Last Update Posted (ACTUAL)

February 24, 2022

Last Update Submitted That Met QC Criteria

February 23, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUB-MAT-DPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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