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

NCT06300151 | Completed DMC

• 1 other identifier: Ultrasound Real-time Guidance
• Study Type: interventional
• Target: 212
• Locations: 1 country
• Sites: 1

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.

Conditions

Labor Analgesia

Keywords

Ultrasound Real-time Guidance; labor analgesia; delivery woman; neonate; Effectiveness; Safety

Outcome Measures

Primary Outcomes (1)

• Composite endpoint of labor analgesia outcome

  The primary outcome is a binary composite endpoint: "satisfactory" (Grades I-II) versus "unsatisfactory" (Grades III-IV). Grading followed a hierarchical rule (IV \> III \> II \> I): if more than one grade applied, the highest (worst) was assigned. Grade I (best): vaginal delivery (spontaneous or instrumental) with analgesic onset ≤ 20 min, mean VAS ≤ 40 mm, no catheter or protocol adjustment, and modified Bromage score \< 2. Grade II (good): vaginal delivery not meeting Grade I criteria but with onset ≤ 30 min, mean VAS ≤ 60 mm, and no Grade IV-listed complications. Grade III (poor): cesarean delivery, or onset \> 30 min, or mean VAS \> 60 mm. Grade IV (worst): serious analgesia-related complications (unintended dural puncture with the epidural needle, Bromage score ≥ 2, persistent neurological injury, local anesthetic toxicity, or severe hypotension requiring intervention).

  From initiation of labor analgesia to delivery (assessed up to 24 hours).

Secondary Outcomes (26)

• Time to analgesia onset

  Within 30 minutes after initial drug administration.

• Visual Analogue Scale (VAS) score

  From initiation of labor analgesia to delivery (assessed up to 24 hours).

• Number of patient-controlled analgesia (PCA) demands

  From initiation of labor analgesia to delivery (assessed up to 24 hours).

• Local anesthetic consumption

  From initiation of labor analgesia to delivery (assessed up to 24 hours).

• Sensory blockade level

  During the labor analgesia period (assessed up to 24 hours).

Study Arms (2)

Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group

EXPERIMENTAL

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

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

Dural Puncture Epidural Group

ACTIVE COMPARATOR

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.

Device: Dural Puncture Epidural Labor Analgesia

Interventions

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

Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group

Dural Puncture Epidural Labor Analgesia 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.

Dural Puncture Epidural Group

Eligibility Criteria

• Age: 20 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• American Society of Anesthesiologists (ASA) Class I or II;
• Single healthy pregnancy;
• Head showing first;
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zongxun Lin: lead

Study Sites (1)

Fujian Provincial Hospital

Fuzhou, Fujian, 350001, China

Location

Study Officials

• Zongxun Lin, Master

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2024
• First Posted: March 8, 2024
• Study Start: April 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)