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

Sponsor

Zongxun Lin (Other)

Overall Status

Recruiting

CT.gov ID

NCT05990504

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Labor Analgesia	Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia Device: ultrasound real-time guidance combined with Epidural Labor Anagesia	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Dural Puncture Epidural Group Dural Puncture Epidural is a new type of labor analgesia technology.	Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia 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.
Active Comparator: Epidural Group Epidural is a traditional labor analgesia technique.	Device: ultrasound real-time guidance combined with Epidural Labor Anagesia Epidural is a traditional labor analgesia technique.

Arm

Intervention/Treatment

Experimental: Dural Puncture Epidural Group

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

Device: ultrasound real-time guidance combined with Dural Puncture Epidural Labor Anagesia

Active Comparator: Epidural Group

Epidural is a traditional labor analgesia technique.

Device: ultrasound real-time guidance combined with Epidural Labor Anagesia

Epidural is a traditional labor analgesia technique.

Outcome Measures

Primary Outcome Measures

Analgesic effect（onset time） [7 weeks]
Analgesic effect of pregnant women（onset time）
Analgesic effect（block level） [7 weeks]
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） [7 weeks]
block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
Analgesic effect（Visual Analogue Scale） [7 weeks]
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） [7 weeks]
number and time of Patient controlled analgesia（Press the PCA button when the patient feels pain）
Uterine contraction indicators（Frequency） [7 weeks]
Assess uterine contractions（Frequency）
Uterine contraction indicators（duration） [7 weeks]
Assess uterine contractions（duration）
Uterine contraction indicators（Number of pregnant women with Tachysystole） [7 weeks]
Tachysystole=More than 5 Uterine contraction in 10 minutes
Uterine contraction indicators（Number of pregnant women with hypertonus） [7 weeks]
hypertonus=Each Uterine contraction lasts for more than 2 minutes
Fetal heart indicators（Fetal heart rate） [7 weeks]
Assess fetal heart（Fetal heart rate）
Fetal heart indicators（NICHD classification） [7 weeks]
Assess fetal heart（NICHD classification）
Fetal heart indicators（Fetal Heart Rate decelerations） [7 weeks]
Assess fetal heart（Fetal Heart Rate decelerations）
Fetal heart indicators（Fetal Heart Rate Variability） [7 weeks]
Assess fetal heart（Fetal Heart Rate Variability）
Apgar score [7 weeks]
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 [7 weeks]
Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block））
modified bromage score [7 weeks]
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） [7 weeks]
Assessment of puncture condition（Time）
Operation evaluation（number of times） [7 weeks]
Assessment of puncture condition（number of times）
Operation evaluation（side effects and Complications） [7 weeks]
Assessment of puncture condition（side effects and Complications）
Delivery mode [7 weeks]
natural labor/cesarean section/instrument
Concentration of Interleukin 6 [7 weeks]
Pregnant women's venous blood Interleukin 6
Concentration of hypersensitive C-reactive protein [7 weeks]
Pregnant women's venous blood hypersensitive C-reactive protein
Concentration of cortisol [7 weeks]
Pregnant women's venous blood cortisol
Maternal rehabilitation indicators（Postpartum hospital stay） [7 weeks]
Postpartum hospitalization days
Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale） [7 weeks]
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）） [7 weeks]
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 [7 weeks]
adjustment method include Adjust the Epidural catheter or Adjusting drug dosage
Drug consumption [7 weeks]
Drug consumption
Effect of stages of labor（time） [7 weeks]
Effect of stages of labor（time）
body temperature changes [7 weeks]
body temperature changes
Number of pregnant women with Infection during labor [7 weeks]
whether Infection during labor of pregnant women
Side effects and complications of labor analgesia [7 weeks]
Side effects and complications of labor analgesia
Number of pregnant women and reason with conversion of natural labor to Caesarean section [7 weeks]
Reasons for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)
Self-Rating Anxiety Scale [7 weeks]
Self-Rating Anxiety Scale（scale title=Self-Rating Anxiety Scale，Total score=0-80，≥50=Anxiety）
Delivery fear score（numerical rating scale） [7 weeks]
Delivery fear score by numerical rating scale（scale title=numerical rating scale，Total score=0-10，≥6=Delivery fear）
Delivery satisfaction survey [7 weeks]
Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts 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.