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

Labor Analgesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300151
• Other study ID #: Ultrasound Real-time Guidance
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2024
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2024
• Source: Fujian Provincial Hospital
• Contact: Zongxun Lin, Master
• Phone: +8613763820916
• Email: 13763820916[@]189.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 1, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Labor Analgesia

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	Fujian Provincial Hospital	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
Zongxun Lin

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Analgesic effect(onset time)	Analgesic effect of pregnant women(onset time)	7 weeks
Primary	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
Primary	Analgesic effect(block effect)	block effect of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block)	7 weeks
Primary	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
Primary	Analgesic effect(number of Patient controlled analgesia)	number of Patient controlled analgesia(Press the PCA button when the patient feels pain)	7 weeks
Primary	Analgesic effect(time of Patient controlled analgesia)	time of Patient controlled analgesia(Press the PCA button when the patient feels pain)	7 weeks
Primary	Uterine contraction indicators(Frequency)	Assess uterine contractions(Frequency)	7 weeks
Primary	Uterine contraction indicators(duration)	Assess uterine contractions(duration)	7 weeks
Primary	Uterine contraction indicators(Number of pregnant women with Tachysystole)	Tachysystole=More than 5 Uterine contraction in 10 minutes	7 weeks
Primary	Uterine contraction indicators(Number of pregnant women with hypertonus)	hypertonus=Each Uterine contraction lasts for more than 2 minutes	7 weeks
Primary	Fetal heart indicators(Fetal heart rate)	Assess fetal heart(Fetal heart rate)	7 weeks
Primary	Fetal heart indicators(NICHD classification)	Assess fetal heart(NICHD classification)	7 weeks
Primary	Fetal heart indicators(Fetal Heart Rate decelerations)	Assess fetal heart(Fetal Heart Rate decelerations)	7 weeks
Primary	Fetal heart indicators(Fetal Heart Rate Variability)	Assess fetal heart(Fetal Heart Rate Variability)	7 weeks
Primary	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
Primary	Sacral sensory block of pregnant women	Sacral sensory block of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block)	7 weeks
Primary	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	Operation evaluation(Time)	Assessment of puncture condition(Time)	7 weeks
Secondary	Operation evaluation(number of times)	Assessment of puncture condition(number of times)	7 weeks
Secondary	Operation evaluation(side effects and Complications)	Assessment of puncture condition(side effects and Complications)	7 weeks
Secondary	Delivery mode	natural labor/cesarean section/instrument	7 weeks
Secondary	Concentration of Interleukin 6	Pregnant women's venous blood Interleukin 6	7 weeks
Secondary	Concentration of hypersensitive C-reactive protein	Pregnant women's venous blood hypersensitive C-reactive protein	7 weeks
Secondary	Concentration of cortisol	Pregnant women's venous blood cortisol	7 weeks
Secondary	Maternal rehabilitation indicators(Postpartum hospital stay)	Postpartum hospitalization days	7 weeks
Secondary	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
Secondary	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
Secondary	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
Secondary	Drug consumption	Drug consumption	7 weeks
Secondary	Effect of stages of labor(time)	Effect of stages of labor(time)	7 weeks
Secondary	body temperature changes	body temperature changes	7 weeks
Secondary	Number of pregnant women with Infection during labor	whether Infection during labor of pregnant women	7 weeks
Secondary	Side effects and complications of labor analgesia	Side effects and complications of labor analgesia	7 weeks
Secondary	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
Secondary	Self-Rating Anxiety Scale	Self-Rating Anxiety Scale(scale title=Self-Rating Anxiety Scale,Total score=0-80,=50=Anxiety)	7 weeks
Secondary	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
Secondary	Delivery satisfaction survey	Delivery satisfaction survey(0=very satisfied, 1=satisfied, 2=common, 3=dissatisfied)	7 weeks