Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia

Combined Implementation of Dural Puncture Epidural Technique and Programmed Intermittent Epidural Bolus for Labor Analgesia

This study intends to carry out a prospective, randomized double-blind study to evaluate the safety and efficacy of the combined implementation of Dural puncture epidural (DPE) technique and Programmed intermittent epidural bolus (PIEB) for labor analgesia.

Study Overview

Detailed Description

Epidural (EPL) technique is the standard technique for labor analgesia, but can be associated with slow onset and inadequate sacral spread, unilateral or patchy sensory blockade, motor impairment. The combined spinal epidural (CSE) technique can provide rapid onset of analgesia, but is associated with greater side effects, including pruritus, fetal bradycardia and delayed testing of epidural catheters. Dural puncture epidural (DPE) technique is a modification of CSE technique. A spinal needle is introduced through the epidural needle to create a single dural puncture , after intrathecal space was identified by the free flow of cerebrospinal fluid (CSF) , the needle was removed without direct medication administration into the subarachnoid space. Privous studies have demonstrated that the DPE technique can improve block quality over the EPL technique with fewer maternal and fetal side effects than the CSE technique for parturients requesting labor analgesia. Besides the neuraxial techniques, maintenance regimens is another factor that affect the analgesic effect. Programmed intermittent epidural bolus (PIEB) provides greater spread of local anesthetic solution within the epidural space and therefore superior quality of analgesia compared with continuous epidural infusion (CEI). We designed this prospective randomized, double-blind study to evaluate the safety and efficacy of the combined implementation of DPE technique and PIEB for labor analgesia.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Not Applicable

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

      • Shanghai, China
        • Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

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

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. women requeste labor analgesia
  2. ASA I or II
  3. at 37-42 weeks' gestation
  4. nulliparous
  5. singleton pregnancy, vertex presentation
  6. visual Numerical Rating Scale (VNRS) at requesting analgesia > 5 (NRPS 0-10)
  7. cervical dilatation < 5 cm

Exclusion Criteria:

  1. patient refusal to participate in the study
  2. age <20 years or >40 years
  3. body mass Index(BMI)>50 (Kg/m2)
  4. clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes)
  5. contraindications to neuraxial analgesia
  6. drug abuse
  7. conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies

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 Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EPL and CEI
Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)

Procedure: Standard epidural placement(EPL)

Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL

Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA).

Active Comparator: DPE and CEI
Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)

Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space.

Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL

Device: Infusion pump Infusion pump set to continuous epidural infusion(CEI) plus patient-controlled epidural analgesia (PCEA).

Active Comparator: DPE and PIEB
Those with receive a dural puncture labor epidural (DPE) and programmed intermittent epidural boluses(PIEB) + patient-controlled epidural analgesia (PCEA)

Procedure: Dural puncture epidural (DPE) Epidural with spinal needle placed to create a single dural puncture and confirm free flow of cerebral spinal fluid (CSF) , without direct medication administration into the subarachnoid space.

Drug: ropivacaine Drug: sufentani 0.1% ropivacaine + sufentanil 0.3μg/mL

Device: Infusion pump Infusion pump set to programmed intermittent epidural boluses (PIEB) plus patient-controlled epidural analgesia (PCEA).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare time of onset of labor analgesia among the study groups
Time Frame: From epidural infusion initiate to delivery
Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale
From epidural infusion initiate to delivery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of side effect
Time Frame: 24 hours post delivery
maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage
24 hours post delivery
Sensory block level
Time Frame: 24 hours post delivery
Sensory block will be assessed bilaterally
24 hours post delivery
Total anesthetic dose required
Time Frame: From epidural infusion initiate to 1h post delivery
Including physician interventions, programmed doses, and patient controlled doses
From epidural infusion initiate to 1h post delivery
Mode of delivery
Time Frame: From epidural infusion initiate to delivery
Spontaneous, Instrumental, or cesarean delivery
From epidural infusion initiate to delivery
Apgar scores
Time Frame: 30 mins post delivery
The Apgar scale is determined by evaluating the newborn baby on five simple criteria on a scale from zero to two, then summing up the five values thus obtained. The resulting Apgar score ranges from zero to 10. The five criteria are skin color, pulse rate, reflex irritability grimace, activity and respiratoty effort
30 mins post delivery

Collaborators and Investigators

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

Investigators

  • Study Chair: YuJie Song, MD, Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine

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 (Actual)

October 10, 2017

Primary Completion (Actual)

June 8, 2018

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

December 4, 2017

First Submitted That Met QC Criteria

December 4, 2017

First Posted (Actual)

December 8, 2017

Study Record Updates

Last Update Posted (Actual)

August 1, 2018

Last Update Submitted That Met QC Criteria

July 30, 2018

Last Verified

July 1, 2018

More Information

Terms related to this study

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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