Clinical trial NCT05990504: The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
Official title: The Effect of Dural Puncture Epidural Block Technique on the Effectiveness and Safety of Labor Analgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Analgesia
Keywords: labor analgesia
delivery woman
neonate
Effectiveness
Safety
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2023-08-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analgesic effect（onset time）
timeFrame: 7 weeks
measure: Analgesic effect（block level）
timeFrame: 7 weeks
measure: Analgesic effect（block effect）
timeFrame: 7 weeks
measure: Analgesic effect（Visual Analogue Scale）
timeFrame: 7 weeks
measure: Analgesic effect（Patient controlled analgesia）
timeFrame: 7 weeks
measure: Uterine contraction indicators（Frequency）
timeFrame: 7 weeks
measure: Uterine contraction indicators（duration）
timeFrame: 7 weeks
measure: Uterine contraction indicators（Number of pregnant women with Tachysystole）
timeFrame: 7 weeks
measure: Uterine contraction indicators（Number of pregnant women with hypertonus）
timeFrame: 7 weeks
measure: Fetal heart indicators（Fetal heart rate）
timeFrame: 7 weeks
measure: Fetal heart indicators（NICHD classification）
timeFrame: 7 weeks
measure: Fetal heart indicators（Fetal Heart Rate decelerations）
timeFrame: 7 weeks
measure: Fetal heart indicators（Fetal Heart Rate Variability）
timeFrame: 7 weeks
measure: Apgar score
timeFrame: 7 weeks
measure: Sacral sensory block of pregnant women
timeFrame: 7 weeks
measure: modified bromage score
timeFrame: 7 weeks
Secondary outcomes:
measure: Operation evaluation（Time）
timeFrame: 7 weeks
measure: Operation evaluation（number of times）
timeFrame: 7 weeks
measure: Operation evaluation（side effects and Complications）
timeFrame: 7 weeks
measure: Delivery mode
timeFrame: 7 weeks
measure: Concentration of Interleukin 6
timeFrame: 7 weeks
measure: Concentration of hypersensitive C-reactive protein
timeFrame: 7 weeks
measure: Concentration of cortisol
timeFrame: 7 weeks
measure: Maternal rehabilitation indicators（Postpartum hospital stay）
timeFrame: 7 weeks
measure: Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）
timeFrame: 7 weeks
measure: Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））
timeFrame: 7 weeks
measure: Number of pregnant women with adjust the treatment plan and adjustment method
timeFrame: 7 weeks
measure: Drug consumption
timeFrame: 7 weeks
measure: Effect of stages of labor（time）
timeFrame: 7 weeks
measure: body temperature changes
timeFrame: 7 weeks
measure: Number of pregnant women with Infection during labor
timeFrame: 7 weeks
measure: Side effects and complications of labor analgesia
timeFrame: 7 weeks
measure: Number of pregnant women and reason with conversion of natural labor to Caesarean section
timeFrame: 7 weeks
measure: Self-Rating Anxiety Scale
timeFrame: 7 weeks
measure: Delivery fear score（numerical rating scale）
timeFrame: 7 weeks
measure: Delivery satisfaction survey
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Zongxun Lin, Master
role: PRINCIPAL_INVESTIGATOR
References: