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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age20-45
SponsorZongxun Lin

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

American Society of Anesthesiologists (ASA) Class I or II;

Single healthy pregnancy;

Head showing first;

37 to 41 weeks;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Ultrasound Real-time Guidance combined with Dural Puncture Epidural GroupExperimental treatment 1 intervention
Group B: Dural Puncture Epidural GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Analgesic effect(onset time)

Analgesic effect of pregnant women(onset time)

Time frame
7 weeks
2

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)

Time frame
7 weeks
3

Analgesic effect(block effect)

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

Time frame
7 weeks
4

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)

Time frame
7 weeks

Secondary outcomes

1

Operation evaluation(Time)

Assessment of puncture condition(Time)

Time frame
7 weeks
2

Operation evaluation(number of times)

Assessment of puncture condition(number of times)

Time frame
7 weeks
3

Operation evaluation(side effects and Complications)

Assessment of puncture condition(side effects and Complications)

Time frame
7 weeks
4

Delivery mode

natural labor/cesarean section/instrument

Time frame
7 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Zongxun Lin

Lead sponsor

Fujian Provincial Hospital

Sponsor institution