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

Primary Purpose

Labor Pain, Labor Analgesia

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
EPL and CEI
DPE and CEI
DPE and PIEB
Sponsored by
Shanghai First Maternity and Infant Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Pain focused on measuring labor analgesia, dural puncture epidural (DPE), standard Epidural (EPL), continuous epidural infusion (CEI), programmed intermittent epidural bolus (PIEB)

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Active Comparator

Arm Label

EPL and CEI

DPE and CEI

DPE and PIEB

Arm Description

Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)

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

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

Outcomes

Primary Outcome Measures

Compare time of onset of labor analgesia among the study groups
Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale

Secondary Outcome Measures

Incidence of side effect
maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage
Sensory block level
Sensory block will be assessed bilaterally
Total anesthetic dose required
Including physician interventions, programmed doses, and patient controlled doses
Mode of delivery
Spontaneous, Instrumental, or cesarean delivery
Apgar scores
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

Full Information

First Posted
December 4, 2017
Last Updated
July 30, 2018
Sponsor
Shanghai First Maternity and Infant Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03366935
Brief Title
Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia
Official Title
Combined Implementation of Dural Puncture Epidural Technique and Programmed Intermittent Epidural Bolus for Labor Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 10, 2017 (Actual)
Primary Completion Date
June 8, 2018 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai First Maternity and Infant Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Pain, Labor Analgesia
Keywords
labor analgesia, dural puncture epidural (DPE), standard Epidural (EPL), continuous epidural infusion (CEI), programmed intermittent epidural bolus (PIEB)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EPL and CEI
Arm Type
Experimental
Arm Description
Those with receive a standard epidural (EPL) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
Arm Title
DPE and CEI
Arm Type
Active Comparator
Arm Description
Those with receive a dural puncture labor epidural (DPE) and continuous epidural infusion(CEI) + patient-controlled epidural analgesia (PCEA)
Arm Title
DPE and PIEB
Arm Type
Active Comparator
Arm Description
Those with receive a dural puncture labor epidural (DPE) and programmed intermittent epidural boluses(PIEB) + patient-controlled epidural analgesia (PCEA)
Intervention Type
Other
Intervention Name(s)
EPL and CEI
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
DPE and CEI
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
DPE and PIEB
Intervention Description
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).
Primary Outcome Measure Information:
Title
Compare time of onset of labor analgesia among the study groups
Description
Visual Numerical Rating Scale (VNRS) ≤ 10 mm on a 100-mm scale
Time Frame
From epidural infusion initiate to delivery
Secondary Outcome Measure Information:
Title
Incidence of side effect
Description
maternal hypotension,fetal bradycardia, maternal motor block,post-dural puncture headache,nausea, vomiting,pruritus,nerve damage
Time Frame
24 hours post delivery
Title
Sensory block level
Description
Sensory block will be assessed bilaterally
Time Frame
24 hours post delivery
Title
Total anesthetic dose required
Description
Including physician interventions, programmed doses, and patient controlled doses
Time Frame
From epidural infusion initiate to 1h post delivery
Title
Mode of delivery
Description
Spontaneous, Instrumental, or cesarean delivery
Time Frame
From epidural infusion initiate to delivery
Title
Apgar scores
Description
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
Time Frame
30 mins post delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Pregnant patients
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: women requeste labor analgesia ASA I or II at 37-42 weeks' gestation nulliparous singleton pregnancy, vertex presentation visual Numerical Rating Scale (VNRS) at requesting analgesia > 5 (NRPS 0-10) cervical dilatation < 5 cm Exclusion Criteria: patient refusal to participate in the study age <20 years or >40 years body mass Index(BMI)>50 (Kg/m2) clinically significant diseases of pregnancy (i.e.,gestational hypertension, preeclampsia, gestational placenta previa, placental abruption diabetes) contraindications to neuraxial analgesia drug abuse conditions associated with an increased risk of a cesarean delivery (i.e., history of uterine anomaly or surgery, morbid obesity) and known anomalies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YuJie Song, MD
Organizational Affiliation
Department of Anesthesiaology, Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
Official's Role
Study Chair
Facility Information:
Facility Name
Shanghai First Maternity and Infant Hospital, Tongji University School of Medicine
City
Shanghai
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
11605932
Citation
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Groden J, Gonzalez-Fiol A, Aaronson J, Sachs A, Smiley R. Catheter failure rates and time course with epidural versus combined spinal-epidural analgesia in labor. Int J Obstet Anesth. 2016 May;26:4-7. doi: 10.1016/j.ijoa.2016.01.004. Epub 2016 Jan 14.
Results Reference
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Combined Implementation of Dural Puncture Epidural and Programmed Intermittent Epidural Bolus for Labor Analgesia

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