The Effect of Ultrasound Real-time Guidance Technique on the Effectiveness and Safety of Labor Analgesia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 212
- Locations
- 1
- Primary Endpoint
- Analgesic effect（block level）
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 20 Years to 45 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Ultrasound Real-time Guidance combined with Dural Puncture Epidural Group
Ultrasound real-time guidance combined with dural puncture epidural Can improve the clinical effect of labor analgesia.
Intervention: Ultrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia (Device)
Dural Puncture Epidural Group
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.
Intervention: Dural Puncture Epidural Labor Analgesia (Device)
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)）
Composite endpoint of labor analgesia outcome
Time Frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
The primary outcome is a binary composite endpoint: "satisfactory" (Grades I-II) versus "unsatisfactory" (Grades III-IV). Grading followed a hierarchical rule (IV \> III \> II \> I): if more than one grade applied, the highest (worst) was assigned. Grade I (best): vaginal delivery (spontaneous or instrumental) with analgesic onset ≤ 20 min, mean VAS ≤ 40 mm, no catheter or protocol adjustment, and modified Bromage score \< 2. Grade II (good): vaginal delivery not meeting Grade I criteria but with onset ≤ 30 min, mean VAS ≤ 60 mm, and no Grade IV-listed complications. Grade III (poor): cesarean delivery, or onset \> 30 min, or mean VAS \> 60 mm. Grade IV (worst): serious analgesia-related complications (unintended dural puncture with the epidural needle, Bromage score ≥ 2, persistent neurological injury, local anesthetic toxicity, or severe hypotension requiring intervention).
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)
- Number of patient-controlled analgesia (PCA) demands(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Time to analgesia onset(Within 30 minutes after initial drug administration.)
- Visual Analogue Scale (VAS) score(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Local anesthetic consumption(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Sensory blockade level(During the labor analgesia period (assessed up to 24 hours).)
- Incidence of asymmetric block(During the labor analgesia period (assessed up to 24 hours).)
- Sensory blockade at the second sacral dermatome (S2)(During the labor analgesia period (assessed up to 24 hours).)
- Number of Participants with Physician Interventions(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Modified Bromage score(During the labor analgesia period (assessed up to 24 hours).)
- Side effects of labor analgesia(From analgesia initiation until delivery and postpartum (assessed up to 72 hours).)
- Cesarean delivery rate and indications(At delivery.)
- Mean uterine contraction frequency(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Mean single uterine contraction duration(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Incidence of uterine hypertonia(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Incidence of uterine tachysystole(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Duration of each stage of labor(From labor onset to delivery of the placenta (assessed up to 24 hours).)
- Maternal body temperature(Pre-analgesia and at delivery.)
- NICHD fetal heart rate tracing classification(From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).)
- NICHD category progression rate(From baseline (pre-analgesia) through delivery (assessed up to 24 hours).)
- Fetal heart rate(From initiation of labor analgesia to delivery (assessed up to 24 hours).)
- Fetal heart rate decelerations(From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).)
- Fetal heart rate variability(From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).)
- Neonatal Apgar scores(At 1, 5, and 10 minutes after birth.)
- Post-delivery hs-CRP level(Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.)
- Post-delivery IL-6 level(Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.)
- Post-delivery cortisol level(Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.)
Investigators
Zongxun Lin
Principal Investigator
Fujian Provincial Hospital