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

Study Overview

• Status: Recruiting
• Conditions: Labor Analgesia
• Intervention / Treatment: Device: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia; Device: Dural Puncture Epidural Labor Analgesia

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Zongxun Lin, Master; Phone Number: +8613763820916; Email: 13763820916@189.cn

Study Locations

• China
  • Fujian
    • Fuzhou, Fujian, China, 350001
      • Recruiting
      • Fujian Provincial Hospital
      • Contact: Zongxun Lin, Master; Phone Number: +8613763820916; Email: 13763820916@189.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: 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.
Active Comparator: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
Sacral sensory block of pregnant women	Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）	7 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Operation evaluation（Time）	Assessment of puncture condition（Time）	7 weeks
Operation evaluation（number of times）	Assessment of puncture condition（number of times）	7 weeks
Operation evaluation（side effects and Complications）	Assessment of puncture condition（side effects and Complications）	7 weeks
Delivery mode	natural labor/cesarean section/instrument	7 weeks
Concentration of Interleukin 6	Pregnant women's venous blood Interleukin 6	7 weeks
Concentration of hypersensitive C-reactive protein	Pregnant women's venous blood hypersensitive C-reactive protein	7 weeks
Concentration of cortisol	Pregnant women's venous blood cortisol	7 weeks
Maternal rehabilitation indicators（Postpartum hospital stay）	Postpartum hospitalization days	7 weeks
Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）	Edinburgh Postnatal Depression Scale（scale title=Edinburgh Postnatal Depression Scale，Total score=0-30，≥13=Postpartum depression）	7 weeks
Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））	Postoperative Recovery Quality Scale（QOR-40）（scale title=Postoperative Recovery Quality Scale（QOR-40），Total score=0-200，The higher the score the better the recovery）	7 weeks
Number of pregnant women with adjust the treatment plan and adjustment method	adjustment method include Adjust the Epidural catheter or Adjusting drug dosage	7 weeks
Drug consumption	Drug consumption	7 weeks
Effect of stages of labor（time）	Effect of stages of labor（time）	7 weeks
body temperature changes	body temperature changes	7 weeks
Number of pregnant women with Infection during labor	whether Infection during labor of pregnant women	7 weeks
Side effects and complications of labor analgesia	Side effects and complications of labor analgesia	7 weeks
Self-Rating Anxiety Scale	Self-Rating Anxiety Scale（scale title=Self-Rating Anxiety Scale，Total score=0-80，≥50=Anxiety）	7 weeks
Delivery fear score（numerical rating scale）	Delivery fear score by numerical rating scale（scale title=numerical rating scale，Total score=0-10，≥6=Delivery fear）	7 weeks
Delivery satisfaction survey	Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)	7 weeks
The reasons and number of pregnant women with conversion of natural labor to Caesarean section	Reasons and number for conversion of natural labor to Caesarean section (pregnant woman, fetus, anesthesia, others)	7 weeks

Collaborators and Investigators

• Sponsor: Zongxun Lin
• Investigators: Principal Investigator: Zongxun Lin, Master, Fujian Provincial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2024
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: March 1, 2024
• First Submitted That Met QC Criteria: March 7, 2024
• First Posted (Actual): March 8, 2024

Study Record Updates

• Last Update Posted (Actual): August 22, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: Safety; Effectiveness; neonate; labor analgesia; delivery woman; Ultrasound Real-time Guidance
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Neurobehavioral Manifestations; Perceptual Disorders; Agnosia
• Other Study ID Numbers: Ultrasound Real-time Guidance

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No