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

NCT06300151 | Recruiting DMC

• 1 other identifier: Ultrasound Real-time Guidance
• Study Type: interventional
• Target: 80
• 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 (17)

• Analgesic effect（onset time）

  Analgesic effect of pregnant women（onset time）

  7 weeks

• 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

• Analgesic effect（block effect）

  block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）

  7 weeks

• 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

• Analgesic effect（number of Patient controlled analgesia）

  number of Patient controlled analgesia（Press the PCA button when the patient feels pain）

  7 weeks

• Analgesic effect（time of Patient controlled analgesia）

  time of Patient controlled analgesia（Press the PCA button when the patient feels pain）

  7 weeks

• Uterine contraction indicators（Frequency）

  Assess uterine contractions（Frequency）

  7 weeks

• Uterine contraction indicators（duration）

  Assess uterine contractions（duration）

  7 weeks

• Uterine contraction indicators（Number of pregnant women with Tachysystole）

  Tachysystole=More than 5 Uterine contraction in 10 minutes

  7 weeks

• Uterine contraction indicators（Number of pregnant women with hypertonus）

  hypertonus=Each Uterine contraction lasts for more than 2 minutes

  7 weeks

• Fetal heart indicators（Fetal heart rate）

  Assess fetal heart（Fetal heart rate）

  7 weeks

• Fetal heart indicators（NICHD classification）

  Assess fetal heart（NICHD classification）

  7 weeks

• Fetal heart indicators（Fetal Heart Rate decelerations）

  Assess fetal heart（Fetal Heart Rate decelerations）

  7 weeks

• Fetal heart indicators（Fetal Heart Rate Variability）

  Assess fetal heart（Fetal Heart Rate Variability）

  7 weeks

• 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

• Sacral sensory block of pregnant women

  Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）

  7 weeks

• 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 Outcomes (20)

• Operation evaluation（Time）

  7 weeks

• Operation evaluation（number of times）

  7 weeks

• Operation evaluation（side effects and Complications）

  7 weeks

• Delivery mode

  7 weeks

• Concentration of Interleukin 6

  7 weeks

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

RECRUITING

Study Officials

• Zongxun Lin, Master

  Fujian Provincial Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zongxun Lin, Master

CONTACT

+8613763820916; 13763820916@189.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, 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 1, 2025
• Study Completion: December 31, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)