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

Labor Analgesia Clinical Trial

— DPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05990504
• Other study ID #: Dural Puncture Epidural
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: September 2023
• Source: Fujian Provincial Hospital
• Contact: Zongxun Lin, Master
• Phone: +8613763820916
• Email: 13763820916[@]189.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: September 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

Inclusion Criteria:

1. American Society of Anesthesiologists (ASA) Class I or II;

2. Single healthy pregnancy;

3. Head showing first;

4. 37 to 41 weeks;

5. The labor process is active, and the cervix dilates<5cm;

6. Require epidural labor analgesia;

7. Volunteer to participate in this study and sign an informed consent form.

Exclusion Criteria:

1. Presence of pregnancy diseases, such as pregnancy hypertension, pre eclampsia, pregnancy diabetes;

2. Contraindications to intraspinal analgesia: 1) Central nervous system diseases. 2) Infection or septicemia at the puncture site. 3) Coagulation dysfunction;

3. Known cases of fetal malformation or increased risk of cesarean section, such as a history of uterine rupture;

4. Persons with a history of mental illness, hysteria, epilepsy, etc. who cannot cooperate.

5. Patients with long-term use of opioids, steroids, and chronic pain.

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

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.
• ultrasound real-time guidance combined with Epidural Labor Anagesia
Epidural is a traditional labor analgesia technique.

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Zongxun Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic effect(onset time)	Analgesic effect of pregnant women(onset time)	7 weeks
Primary	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)	7 weeks
Primary	Analgesic effect(block effect)	block effect of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block)	7 weeks
Primary	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)	7 weeks
Primary	Analgesic effect(Patient controlled analgesia)	number and time of Patient controlled analgesia(Press the PCA button when the patient feels pain)	7 weeks
Primary	Uterine contraction indicators(Frequency)	Assess uterine contractions(Frequency)	7 weeks
Primary	Uterine contraction indicators(duration)	Assess uterine contractions(duration)	7 weeks
Primary	Uterine contraction indicators(Number of pregnant women with Tachysystole)	Tachysystole=More than 5 Uterine contraction in 10 minutes	7 weeks
Primary	Uterine contraction indicators(Number of pregnant women with hypertonus)	hypertonus=Each Uterine contraction lasts for more than 2 minutes	7 weeks
Primary	Fetal heart indicators(Fetal heart rate)	Assess fetal heart(Fetal heart rate)	7 weeks
Primary	Fetal heart indicators(NICHD classification)	Assess fetal heart(NICHD classification)	7 weeks
Primary	Fetal heart indicators(Fetal Heart Rate decelerations)	Assess fetal heart(Fetal Heart Rate decelerations)	7 weeks
Primary	Fetal heart indicators(Fetal Heart Rate Variability)	Assess fetal heart(Fetal Heart Rate Variability)	7 weeks
Primary	Apgar score	Apgar score(scale title=Apgar score,Total score=0-10,0-3=severe asphyxia,4-7=mild asphyxia,8-10=normal)	7 weeks
Primary	Sacral sensory block of pregnant women	Sacral sensory block of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block))	7 weeks
Primary	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))	7 weeks
Secondary	Operation evaluation(Time)	Assessment of puncture condition(Time)	7 weeks
Secondary	Operation evaluation(number of times)	Assessment of puncture condition(number of times)	7 weeks
Secondary	Operation evaluation(side effects and Complications)	Assessment of puncture condition(side effects and Complications)	7 weeks
Secondary	Delivery mode	natural labor/cesarean section/instrument	7 weeks
Secondary	Concentration of Interleukin 6	Pregnant women's venous blood Interleukin 6	7 weeks
Secondary	Concentration of hypersensitive C-reactive protein	Pregnant women's venous blood hypersensitive C-reactive protein	7 weeks
Secondary	Concentration of cortisol	Pregnant women's venous blood cortisol	7 weeks
Secondary	Maternal rehabilitation indicators(Postpartum hospital stay)	Postpartum hospitalization days	7 weeks
Secondary	Maternal rehabilitation indicators(Edinburgh Postnatal Depression Scale)	Edinburgh Postnatal Depression Scale(scale title=Edinburgh Postnatal Depression Scale,Total score=0-30,=13=Postpartum depression)	7 weeks
Secondary	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)	7 weeks
Secondary	Number of pregnant women with adjust the treatment plan and adjustment method	adjustment method include Adjust the Epidural catheter or Adjusting drug dosage	7 weeks
Secondary	Drug consumption	Drug consumption	7 weeks
Secondary	Effect of stages of labor(time)	Effect of stages of labor(time)	7 weeks
Secondary	body temperature changes	body temperature changes	7 weeks
Secondary	Number of pregnant women with Infection during labor	whether Infection during labor of pregnant women	7 weeks
Secondary	Side effects and complications of labor analgesia	Side effects and complications of labor analgesia	7 weeks
Secondary	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)	7 weeks
Secondary	Self-Rating Anxiety Scale	Self-Rating Anxiety Scale(scale title=Self-Rating Anxiety Scale,Total score=0-80,=50=Anxiety)	7 weeks
Secondary	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)	7 weeks
Secondary	Delivery satisfaction survey	Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)	7 weeks