Clinical trial NCT06300151: The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Official title: The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Labor Analgesia
Keywords: Ultrasound Real-time Guidance
labor analgesia
delivery woman
neonate
Effectiveness
Safety
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2024-03-08
Enrollment: 80
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Analgesic effect（onset time）
timeFrame: 7 weeks
measure: Analgesic effect（block level）
timeFrame: 7 weeks
measure: Analgesic effect（block effect）
timeFrame: 7 weeks
measure: Analgesic effect（Visual Analogue Scale）
timeFrame: 7 weeks
measure: Analgesic effect（number of Patient controlled analgesia）
timeFrame: 7 weeks
measure: Analgesic effect（time of Patient controlled analgesia）
timeFrame: 7 weeks
measure: Uterine contraction indicators（Frequency）
timeFrame: 7 weeks
measure: Uterine contraction indicators（duration）
timeFrame: 7 weeks
measure: Uterine contraction indicators（Number of pregnant women with Tachysystole）
timeFrame: 7 weeks
measure: Uterine contraction indicators（Number of pregnant women with hypertonus）
timeFrame: 7 weeks
measure: Fetal heart indicators（Fetal heart rate）
timeFrame: 7 weeks
measure: Fetal heart indicators（NICHD classification）
timeFrame: 7 weeks
measure: Fetal heart indicators（Fetal Heart Rate decelerations）
timeFrame: 7 weeks
measure: Fetal heart indicators（Fetal Heart Rate Variability）
timeFrame: 7 weeks
measure: Apgar score
timeFrame: 7 weeks
measure: Sacral sensory block of pregnant women
timeFrame: 7 weeks
measure: modified bromage score
timeFrame: 7 weeks
Secondary outcomes:
measure: Operation evaluation（Time）
timeFrame: 7 weeks
measure: Operation evaluation（number of times）
timeFrame: 7 weeks
measure: Operation evaluation（side effects and Complications）
timeFrame: 7 weeks
measure: Delivery mode
timeFrame: 7 weeks
measure: Concentration of Interleukin 6
timeFrame: 7 weeks
measure: Concentration of hypersensitive C-reactive protein
timeFrame: 7 weeks
measure: Concentration of cortisol
timeFrame: 7 weeks
measure: Maternal rehabilitation indicators（Postpartum hospital stay）
timeFrame: 7 weeks
measure: Maternal rehabilitation indicators（Edinburgh Postnatal Depression Scale）
timeFrame: 7 weeks
measure: Maternal rehabilitation indicators（Postoperative Recovery Quality Scale（QOR-40））
timeFrame: 7 weeks
measure: Number of pregnant women with adjust the treatment plan and adjustment method
timeFrame: 7 weeks
measure: Drug consumption
timeFrame: 7 weeks
measure: Effect of stages of labor（time）
timeFrame: 7 weeks
measure: body temperature changes
timeFrame: 7 weeks
measure: Number of pregnant women with Infection during labor
timeFrame: 7 weeks
measure: Side effects and complications of labor analgesia
timeFrame: 7 weeks
measure: The reasons and number of pregnant women with conversion of natural labor to Caesarean section
timeFrame: 7 weeks
measure: Self-Rating Anxiety Scale
timeFrame: 7 weeks
measure: Delivery fear score（numerical rating scale）
timeFrame: 7 weeks
measure: Delivery satisfaction survey
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
affiliation: Fujian Provincial Hospital
name: Zongxun Lin, Master
role: PRINCIPAL_INVESTIGATOR
References: