The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Labor Analgesia
- Sponsor
- Zongxun Lin
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Analgesic effect（block level）
- Status
- Recruiting
- Last Updated
- 8 months ago
Overview
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.
Investigators
Zongxun Lin
Principal Investigator
Fujian Provincial Hospital
Eligibility Criteria
Inclusion Criteria
- •American Society of Anesthesiologists (ASA) Class I or II;
- •Single healthy pregnancy;
- •Head showing first;
- •37 to 41 weeks;
- •The labor process is active, and the cervix dilates\<5cm;
- •Require epidural labor analgesia;
- •Volunteer to participate in this study and sign an informed consent form.
Exclusion Criteria
- •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.
- •Patients with long-term use of opioids, steroids, and chronic pain.
Outcomes
Primary Outcomes
Analgesic effect（block level）
Time Frame: 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）
Time Frame: 7 weeks
Assess uterine contractions（Frequency）
Uterine contraction indicators（duration）
Time Frame: 7 weeks
Assess uterine contractions（duration）
Analgesic effect（number of Patient controlled analgesia）
Time Frame: 7 weeks
number of Patient controlled analgesia（Press the PCA button when the patient feels pain）
Fetal heart indicators（Fetal Heart Rate Variability）
Time Frame: 7 weeks
Assess fetal heart（Fetal Heart Rate Variability）
Apgar score
Time Frame: 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）
Time Frame: 7 weeks
Assess fetal heart（NICHD classification）
Sacral sensory block of pregnant women
Time Frame: 7 weeks
Sacral sensory block of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
Analgesic effect（onset time）
Time Frame: 7 weeks
Analgesic effect of pregnant women（onset time）
Analgesic effect（block effect）
Time Frame: 7 weeks
block effect of pregnant women by Alcohol swab（temperature sensation：Unblocked, unilateral block, bilateral block）
Analgesic effect（Visual Analogue Scale）
Time Frame: 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）
Time Frame: 7 weeks
Tachysystole=More than 5 Uterine contraction in 10 minutes
Fetal heart indicators（Fetal Heart Rate decelerations）
Time Frame: 7 weeks
Assess fetal heart（Fetal Heart Rate decelerations）
Analgesic effect（time of Patient controlled analgesia）
Time Frame: 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）
Time Frame: 7 weeks
hypertonus=Each Uterine contraction lasts for more than 2 minutes
Fetal heart indicators（Fetal heart rate）
Time Frame: 7 weeks
Assess fetal heart（Fetal heart rate）
modified bromage score
Time Frame: 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 Outcomes
- Concentration of Interleukin 6(7 weeks)
- Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））(7 weeks)
- Number of pregnant women with adjust the treatment plan and adjustment method(7 weeks)
- body temperature changes(7 weeks)
- Operation evaluation（Time）(7 weeks)
- Delivery mode(7 weeks)
- Effect of stages of labor（time）(7 weeks)
- Maternal rehabilitation indicators（Postpartum hospital stay）(7 weeks)
- Side effects and complications of labor analgesia(7 weeks)
- Drug consumption(7 weeks)
- Operation evaluation（number of times）(7 weeks)
- Operation evaluation（side effects and Complications）(7 weeks)
- Concentration of hypersensitive C-reactive protein(7 weeks)
- Concentration of cortisol(7 weeks)
- Number of pregnant women with Infection during labor(7 weeks)
- Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）(7 weeks)
- Delivery fear score（numerical rating scale）(7 weeks)
- The reasons and number of pregnant women with conversion of natural labor to Caesarean section(7 weeks)
- Delivery satisfaction survey(7 weeks)
- Self-Rating Anxiety Scale(7 weeks)