The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia

NCT ID: NCT06300151

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2025-12-31

Brief Summary

Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block. At present, Doppler ultrasound is rarely used for spinal block, especially for real-time ultrasound guidance technology, which has not been widely applied in clinical practice due to its high equipment requirements, lack of mature puncture plans, complex operation, and high learning curve. If a comprehensive diagnosis and treatment plan can be developed, it will greatly improve the delivery experience of mothers.

Detailed Description

Traditional blind exploration of spinal canal puncture has many limitations, often forcing changes in anesthesia methods due to multiple puncture failures. However, the application of real-time ultrasound guidance technology in spinal canal puncture can completely solve this clinical difficulty. The ultrasound-guided real-time paramedian approach epidural puncture for labor analgesia is a new type of labor analgesia technology, and its specific operating standards and diagnostic and treatment routines have not yet been established, including the selection of puncture path, puncture needle model, distance between puncture hole and epidural injection point, drug type, dosage, solubility, volume and other parameters, all of which have great research space.

Conditions

Labor Analgesia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group

Ultrasound real-time guidance combined with dural puncture epidural Can improve the clinical effect of labor analgesia.

Group Type: EXPERIMENTAL

Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia

Intervention Type: DEVICE

Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block.

Dural Puncture Epidural Group

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.

Group Type: ACTIVE_COMPARATOR

Dural Puncture Epidural Labor Analgesia

Intervention Type: DEVICE

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.

Interventions

Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia

Ultrasound real-time guidance technology has great advantages over traditional blind exploration technology in terms of accuracy, success rate, and reduction of puncture damage in intervertebral space positioning through operational visualization, greatly improving the effectiveness and safety of spinal block.

Intervention Type: DEVICE

Dural Puncture Epidural Labor Analgesia

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

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zongxun Lin

OTHER

Sponsor Role: lead

Responsible Party

Zongxun Lin

Principal Investigator

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Zongxun Lin, Master

Role: PRINCIPAL_INVESTIGATOR

Fujian Provincial Hospital

Locations

Fujian Provincial Hospital

Fuzhou, Fujian, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zongxun Lin, Master

Role: CONTACT

13763820916@189.cn

+8613763820916

Facility Contacts

Zongxun Lin, Master

Role: primary

13763820916@189.cn

+8613763820916

Other Identifiers

Ultrasound Real-time Guidance

Identifier Type: -

Identifier Source: org_study_id