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

Not Applicable

Recruiting

• Conditions: Labor Analgesia
• Interventions: Device: Dural Puncture Epidural Labor Analgesia; Device: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia

• Registration Number: NCT06300151
• Lead Sponsor: Zongxun Lin

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.

Study Timeline

• Study First Submitted: 2024-03-01
• Study First Submitted QC: 2024-03-07
• Study First Posted: 2024-03-08
• Study Start: 2024-04-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2025-12-01
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dural Puncture Epidural Group	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.
Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group	Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia	Ultrasound real-time guidance combined with dural puncture epidural Can improve the clinical effect of labor analgesia.

Primary Outcome Measures

Name	Time	Method
Analgesic effect（block level）	7 weeks	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）
Uterine contraction indicators（Frequency）	7 weeks	Assess uterine contractions（Frequency）
Uterine contraction indicators（duration）	7 weeks	Assess uterine contractions（duration）
Analgesic effect（number of Patient controlled analgesia）	7 weeks	number of Patient controlled analgesia（Press the PCA button when the patient feels pain）
Fetal heart indicators（Fetal Heart Rate Variability）	7 weeks	Assess fetal heart（Fetal Heart Rate Variability）
Apgar score	7 weeks	Apgar score（scale title=Apgar score，Total score=0-10，0-3=severe asphyxia，4-7=mild asphyxia，8-10=normal）
Fetal heart indicators（NICHD classification）	7 weeks	Assess fetal heart（NICHD classification）
Sacral sensory block of pregnant women	7 weeks	Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
Analgesic effect（onset time）	7 weeks	Analgesic effect of pregnant women（onset time）
Analgesic effect（block effect）	7 weeks	block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
Analgesic effect（Visual Analogue Scale）	7 weeks	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）
Uterine contraction indicators（Number of pregnant women with Tachysystole）	7 weeks	Tachysystole=More than 5 Uterine contraction in 10 minutes
Fetal heart indicators（Fetal Heart Rate decelerations）	7 weeks	Assess fetal heart（Fetal Heart Rate decelerations）
Analgesic effect（time of Patient controlled analgesia）	7 weeks	time of Patient controlled analgesia（Press the PCA button when the patient feels pain）
Uterine contraction indicators（Number of pregnant women with hypertonus）	7 weeks	hypertonus=Each Uterine contraction lasts for more than 2 minutes
Fetal heart indicators（Fetal heart rate）	7 weeks	Assess fetal heart（Fetal heart rate）
modified bromage score	7 weeks	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)）

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fujian Provincial Hospital; 🇨🇳 Fuzhou, Fujian, China