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The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia (DPE)

Primary Purpose

Labor Analgesia

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia
ultrasound real-time guidance combined with Epidural Labor Anagesia
Sponsored by
Zongxun Lin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Labor Analgesia focused on measuring labor analgesia, delivery woman, neonate, Effectiveness, Safety

Eligibility Criteria

20 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: American Society of Anesthesiologists (ASA) Class I or II; Single healthy pregnancy; Head showing first; 37 to 41 weeks; The labor process is active, and the cervix dilates<5cm; Require epidural labor analgesia; Volunteer to participate in this study and sign an informed consent form. Exclusion Criteria: Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes; Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction; Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture; Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate. Patients with long-term use of opioids, steroids, and chronic pain.

Sites / Locations

  • Fujian Provincial HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dural Puncture Epidural Group

Epidural Group

Arm Description

Dural Puncture Epidural is a new type of labor analgesia technology.

Epidural is a traditional labor analgesia technique.

Outcomes

Primary Outcome Measures

Analgesic effect(onset time)
Analgesic effect of pregnant women(onset time)
Analgesic effect(block level)
block level of pregnant women by Alcohol swab(temperature sensation:Pubic symphysis=T12,umbilical region=T10,hypochondrium=T8,xiphoid process=T6,Nipple connection=T4,subclavian=T2)
Analgesic effect(block effect)
block effect of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block)
Analgesic effect(Visual Analogue Scale)
Analgesic effect of pregnant women by Visual Analogue Scale(scale title=Visual Analogue Scale,Total score=0-10,0=no pain,10=worst possible pain)
Analgesic effect(Patient controlled analgesia)
number and time of Patient controlled analgesia(Press the PCA button when the patient feels pain)
Uterine contraction indicators(Frequency)
Assess uterine contractions(Frequency)
Uterine contraction indicators(duration)
Assess uterine contractions(duration)
Uterine contraction indicators(Number of pregnant women with Tachysystole)
Tachysystole=More than 5 Uterine contraction in 10 minutes
Uterine contraction indicators(Number of pregnant women with hypertonus)
hypertonus=Each Uterine contraction lasts for more than 2 minutes
Fetal heart indicators(Fetal heart rate)
Assess fetal heart(Fetal heart rate)
Fetal heart indicators(NICHD classification)
Assess fetal heart(NICHD classification)
Fetal heart indicators(Fetal Heart Rate decelerations)
Assess fetal heart(Fetal Heart Rate decelerations)
Fetal heart indicators(Fetal Heart Rate Variability)
Assess fetal heart(Fetal Heart Rate Variability)
Apgar score
Apgar score(scale title=Apgar score,Total score=0-10,0-3=severe asphyxia,4-7=mild asphyxia,8-10=normal)
Sacral sensory block of pregnant women
Sacral sensory block of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block))
modified bromage score
modified bromage score(scale title=modified bromage score,Total score=0-3,0=no Motor nerve block; 1=unable to lift straight legs, but able to bend knees and move feet; 2=unable to lift straight legs or bend knees, but able to move feet; 3=unable to bend ankles, feet, or knees (completely blocked))

Secondary Outcome Measures

Operation evaluation(Time)
Assessment of puncture condition(Time)
Operation evaluation(number of times)
Assessment of puncture condition(number of times)
Operation evaluation(side effects and Complications)
Assessment of puncture condition(side effects and Complications)
Delivery mode
natural labor/cesarean section/instrument
Concentration of Interleukin 6
Pregnant women's venous blood Interleukin 6
Concentration of hypersensitive C-reactive protein
Pregnant women's venous blood hypersensitive C-reactive protein
Concentration of cortisol
Pregnant women's venous blood cortisol
Maternal rehabilitation indicators(Postpartum hospital stay)
Postpartum hospitalization days
Maternal rehabilitation indicators(Edinburgh Postnatal Depression Scale)
Edinburgh Postnatal Depression Scale(scale title=Edinburgh Postnatal Depression Scale,Total score=0-30,≥13=Postpartum depression)
Maternal rehabilitation indicators(Postoperative Recovery Quality Scale(QOR-40))
Postoperative Recovery Quality Scale(QOR-40)(scale title=Postoperative Recovery Quality Scale(QOR-40),Total score=0-200,The higher the score the better the recovery)
Number of pregnant women with adjust the treatment plan and adjustment method
adjustment method include Adjust the Epidural catheter or Adjusting drug dosage
Drug consumption
Drug consumption
Effect of stages of labor(time)
Effect of stages of labor(time)
body temperature changes
body temperature changes
Number of pregnant women with Infection during labor
whether Infection during labor of pregnant women
Side effects and complications of labor analgesia
Side effects and complications of labor analgesia
Number of pregnant women and reason with conversion of natural labor to Caesarean section
Reasons for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)
Self-Rating Anxiety Scale
Self-Rating Anxiety Scale(scale title=Self-Rating Anxiety Scale,Total score=0-80,≥50=Anxiety)
Delivery fear score(numerical rating scale)
Delivery fear score by numerical rating scale(scale title=numerical rating scale,Total score=0-10,≥6=Delivery fear)
Delivery satisfaction survey
Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)

Full Information

First Posted
April 21, 2023
Last Updated
September 3, 2023
Sponsor
Zongxun Lin
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1. Study Identification

Unique Protocol Identification Number
NCT05990504
Brief Title
The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
Acronym
DPE
Official Title
The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 1, 2023 (Actual)
Primary Completion Date
September 1, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Zongxun Lin

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
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal.Dural Puncture Epidural Technique improves Labor Analgesia Quality And Safety By Increasing Drug Permeation.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.
Detailed Description
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block. The theoretical basis is that anesthetic drugs can originally penetrate into the subarachnoid space from the epidural space through a complete spinal dura, and the puncture hole formed by spinal dura puncture facilitates this process.After injecting high volume anesthetic drugs into the epidural space, the pressure increases, and the drug penetrates from the epidural space through the puncture hole along a pressure gradient to the subarachnoid space, thereby enhancing the effect of labor analgesia.Dural Puncture Epidural also has the advantage of verifying that the epidural needle is in the middle of the epidural space again, thereby reducing the incidence of epidural catheter insertion failure or deviation to one side.This study combines ultrasound real-time guidance technology. This technology ensures the accuracy of intervertebral space positioning and puncture success rate through operational visualization, and reduces the impact of operator proficiency on research results.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Labor Analgesia
Keywords
labor analgesia, delivery woman, neonate, Effectiveness, Safety

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dural Puncture Epidural Group
Arm Type
Experimental
Arm Description
Dural Puncture Epidural is a new type of labor analgesia technology.
Arm Title
Epidural Group
Arm Type
Active Comparator
Arm Description
Epidural is a traditional labor analgesia technique.
Intervention Type
Device
Intervention Name(s)
ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia
Intervention Description
Dural Puncture Epidural is a clinical improvement of Combined Spinal-Epidural and is widely used in Maternal. The implementation step is to complete the epidural puncture, temporarily do not place a tube, puncture the dura mater with a subarachnoid anesthesia needle, but do not directly inject drugs into the subarachnoid space, and then leave an epidural catheter for administration according to epidural block.
Intervention Type
Device
Intervention Name(s)
ultrasound real-time guidance combined with Epidural Labor Anagesia
Intervention Description
Epidural is a traditional labor analgesia technique.
Primary Outcome Measure Information:
Title
Analgesic effect(onset time)
Description
Analgesic effect of pregnant women(onset time)
Time Frame
7 weeks
Title
Analgesic effect(block level)
Description
block level of pregnant women by Alcohol swab(temperature sensation:Pubic symphysis=T12,umbilical region=T10,hypochondrium=T8,xiphoid process=T6,Nipple connection=T4,subclavian=T2)
Time Frame
7 weeks
Title
Analgesic effect(block effect)
Description
block effect of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block)
Time Frame
7 weeks
Title
Analgesic effect(Visual Analogue Scale)
Description
Analgesic effect of pregnant women by Visual Analogue Scale(scale title=Visual Analogue Scale,Total score=0-10,0=no pain,10=worst possible pain)
Time Frame
7 weeks
Title
Analgesic effect(Patient controlled analgesia)
Description
number and time of Patient controlled analgesia(Press the PCA button when the patient feels pain)
Time Frame
7 weeks
Title
Uterine contraction indicators(Frequency)
Description
Assess uterine contractions(Frequency)
Time Frame
7 weeks
Title
Uterine contraction indicators(duration)
Description
Assess uterine contractions(duration)
Time Frame
7 weeks
Title
Uterine contraction indicators(Number of pregnant women with Tachysystole)
Description
Tachysystole=More than 5 Uterine contraction in 10 minutes
Time Frame
7 weeks
Title
Uterine contraction indicators(Number of pregnant women with hypertonus)
Description
hypertonus=Each Uterine contraction lasts for more than 2 minutes
Time Frame
7 weeks
Title
Fetal heart indicators(Fetal heart rate)
Description
Assess fetal heart(Fetal heart rate)
Time Frame
7 weeks
Title
Fetal heart indicators(NICHD classification)
Description
Assess fetal heart(NICHD classification)
Time Frame
7 weeks
Title
Fetal heart indicators(Fetal Heart Rate decelerations)
Description
Assess fetal heart(Fetal Heart Rate decelerations)
Time Frame
7 weeks
Title
Fetal heart indicators(Fetal Heart Rate Variability)
Description
Assess fetal heart(Fetal Heart Rate Variability)
Time Frame
7 weeks
Title
Apgar score
Description
Apgar score(scale title=Apgar score,Total score=0-10,0-3=severe asphyxia,4-7=mild asphyxia,8-10=normal)
Time Frame
7 weeks
Title
Sacral sensory block of pregnant women
Description
Sacral sensory block of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block))
Time Frame
7 weeks
Title
modified bromage score
Description
modified bromage score(scale title=modified bromage score,Total score=0-3,0=no Motor nerve block; 1=unable to lift straight legs, but able to bend knees and move feet; 2=unable to lift straight legs or bend knees, but able to move feet; 3=unable to bend ankles, feet, or knees (completely blocked))
Time Frame
7 weeks
Secondary Outcome Measure Information:
Title
Operation evaluation(Time)
Description
Assessment of puncture condition(Time)
Time Frame
7 weeks
Title
Operation evaluation(number of times)
Description
Assessment of puncture condition(number of times)
Time Frame
7 weeks
Title
Operation evaluation(side effects and Complications)
Description
Assessment of puncture condition(side effects and Complications)
Time Frame
7 weeks
Title
Delivery mode
Description
natural labor/cesarean section/instrument
Time Frame
7 weeks
Title
Concentration of Interleukin 6
Description
Pregnant women's venous blood Interleukin 6
Time Frame
7 weeks
Title
Concentration of hypersensitive C-reactive protein
Description
Pregnant women's venous blood hypersensitive C-reactive protein
Time Frame
7 weeks
Title
Concentration of cortisol
Description
Pregnant women's venous blood cortisol
Time Frame
7 weeks
Title
Maternal rehabilitation indicators(Postpartum hospital stay)
Description
Postpartum hospitalization days
Time Frame
7 weeks
Title
Maternal rehabilitation indicators(Edinburgh Postnatal Depression Scale)
Description
Edinburgh Postnatal Depression Scale(scale title=Edinburgh Postnatal Depression Scale,Total score=0-30,≥13=Postpartum depression)
Time Frame
7 weeks
Title
Maternal rehabilitation indicators(Postoperative Recovery Quality Scale(QOR-40))
Description
Postoperative Recovery Quality Scale(QOR-40)(scale title=Postoperative Recovery Quality Scale(QOR-40),Total score=0-200,The higher the score the better the recovery)
Time Frame
7 weeks
Title
Number of pregnant women with adjust the treatment plan and adjustment method
Description
adjustment method include Adjust the Epidural catheter or Adjusting drug dosage
Time Frame
7 weeks
Title
Drug consumption
Description
Drug consumption
Time Frame
7 weeks
Title
Effect of stages of labor(time)
Description
Effect of stages of labor(time)
Time Frame
7 weeks
Title
body temperature changes
Description
body temperature changes
Time Frame
7 weeks
Title
Number of pregnant women with Infection during labor
Description
whether Infection during labor of pregnant women
Time Frame
7 weeks
Title
Side effects and complications of labor analgesia
Description
Side effects and complications of labor analgesia
Time Frame
7 weeks
Title
Number of pregnant women and reason with conversion of natural labor to Caesarean section
Description
Reasons for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)
Time Frame
7 weeks
Title
Self-Rating Anxiety Scale
Description
Self-Rating Anxiety Scale(scale title=Self-Rating Anxiety Scale,Total score=0-80,≥50=Anxiety)
Time Frame
7 weeks
Title
Delivery fear score(numerical rating scale)
Description
Delivery fear score by numerical rating scale(scale title=numerical rating scale,Total score=0-10,≥6=Delivery fear)
Time Frame
7 weeks
Title
Delivery satisfaction survey
Description
Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)
Time Frame
7 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists (ASA) Class I or II; Single healthy pregnancy; Head showing first; 37 to 41 weeks; The labor process is active, and the cervix dilates<5cm; Require epidural labor analgesia; Volunteer to participate in this study and sign an informed consent form. Exclusion Criteria: Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes; Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction; Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture; Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate. Patients with long-term use of opioids, steroids, and chronic pain.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zongxun Lin, Master
Phone
+8613763820916
Email
13763820916@189.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zongxun Lin, Master
Organizational Affiliation
Fujian Provincial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fujian Provincial Hospital
City
Fuzhou
State/Province
Fujian
ZIP/Postal Code
350001
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zongxun Lin, Master
Phone
+8613763820916
Email
13763820916@189.cn

12. IPD Sharing Statement

Plan to Share IPD
No

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The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia

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