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

Zongxun Lin

Status: Completed

Conditions: Labor Analgesia

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05990504

Dural Puncture Epidural

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

200 participants in 2 patient groups

Dural Puncture Epidural Group

Experimental group

Description:

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

Treatment:

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

Epidural Group

Active Comparator group

Description:

Epidural is a traditional labor analgesia technique.

Treatment:

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