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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia
DeviceUltrasound 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
DeviceDural 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
Trial outcomes
Primary outcomes
Analgesic effect(onset time)
Analgesic effect of pregnant women(onset time)
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)
Analgesic effect(block effect)
block effect of pregnant women by Alcohol swab(temperature sensation:Unblocked, unilateral block, bilateral block)
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)
Secondary outcomes
Operation evaluation(Time)
Assessment of puncture condition(Time)
Operation evaluation(number of times)
Assessment of puncture condition(number of times)
Operation evaluation(side effects and Complications)
Assessment of puncture condition(side effects and Complications)
Delivery mode
natural labor/cesarean section/instrument
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Zongxun Lin
Lead sponsor
Fujian Provincial Hospital
Sponsor institution