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.
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
212
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 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.
Fujian Provincial Hospital
Fuzhou, Fujian, China
Composite endpoint of labor analgesia outcome
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).
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Time to analgesia onset
Time from initial drug administration to the first documented Visual Analogue Scale (VAS) score ≤ 30 mm. VAS scale: 0 = no pain, 100 mm = worst possible pain.
Time frame: Within 30 minutes after initial drug administration.
Visual Analogue Scale (VAS) score
Time-weighted mean pain VAS score from analgesia start to delivery, derived from area under the curve (AUC) calculation. VAS scale: 0 = no pain, 100 mm = worst possible pain.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Number of patient-controlled analgesia (PCA) demands
Number of PCA bolus demands during labor analgesia.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Local anesthetic consumption
Per-minute local anesthetic consumption during labor analgesia.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Sensory blockade level
Sensory blockade level assessed by loss of cold sensation using an alcohol swab, recorded at 30 min after the loading dose and at the highest level.
Time frame: During the labor analgesia period (assessed up to 24 hours).
Incidence of asymmetric block
Defined as a ≥ 2-dermatome difference in sensory blockade level between the left and right sides.
Time frame: During the labor analgesia period (assessed up to 24 hours).
Sensory blockade at the second sacral dermatome (S2)
S2 sensory blockade categorized as bilateral, unilateral, or none.
Time frame: During the labor analgesia period (assessed up to 24 hours).
Number of Participants with Physician Interventions
Physician interventions including analgesic regimen adjustments, epidural catheter repositioning, and re-puncture.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Modified Bromage score
Motor blockade assessed by the modified Bromage score: 0 = full flexion of knees and ankles, 1 = partial flexion of knees with full flexion of ankles, 2 = inability to flex knees with partial flexion of ankles, 3 = inability to flex knees and ankles.
Time frame: During the labor analgesia period (assessed up to 24 hours).
Side effects of labor analgesia
Incidence of lower limb numbness (defined as loss of cold sensation by alcohol swab test), urinary retention (defined as inability to void spontaneously within 8 h postpartum requiring catheterization), nausea and vomiting, and postpartum headache.
Time frame: From analgesia initiation until delivery and postpartum (assessed up to 72 hours).
Cesarean delivery rate and indications
Rate of cesarean delivery and indications for cesarean delivery (non-reassuring fetal heart rate, arrest of descent, maternal indications, other).
Time frame: At delivery.
Mean uterine contraction frequency
Time-weighted mean uterine contraction frequency, derived from area under the curve (AUC) calculation from analgesia to delivery. Unit of measure: contractions per 10 minutes
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Mean single uterine contraction duration
Time-weighted mean single uterine contraction duration, derived from area under the curve (AUC) calculation from analgesia to delivery. Unit of measure: seconds.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Incidence of uterine hypertonia
Defined as a single contraction lasting \> 2 min.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Incidence of uterine tachysystole
Defined as \> 5 contractions per 10 min.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Duration of each stage of labor
Duration of the first, second, third, and total stages of labor.
Time frame: From labor onset to delivery of the placenta (assessed up to 24 hours).
Maternal body temperature
Maternal body temperature before analgesia and at delivery.
Time frame: Pre-analgesia and at delivery.
NICHD fetal heart rate tracing classification
NICHD (National Institute of Child Health and Human Development) Fetal Heart Tracing Classification: Category I (normal), Category II (indeterminate), Category III (abnormal). A higher category indicates a less reassuring fetal status.
Time frame: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
NICHD category progression rate
Proportion of parturients whose NICHD category worsened from baseline during labor analgesia.
Time frame: From baseline (pre-analgesia) through delivery (assessed up to 24 hours).
Fetal heart rate
Time-weighted mean fetal heart rate from analgesia to delivery, derived from area under the curve (AUC) calculation.
Time frame: From initiation of labor analgesia to delivery (assessed up to 24 hours).
Fetal heart rate decelerations
Types of fetal heart rate decelerations (early, late, variable).
Time frame: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
Fetal heart rate variability
Fetal heart rate variability categorized as absent, minimal, moderate, or marked.
Time frame: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
Neonatal Apgar scores
Apgar scores assessed at 1, 5, and 10 minutes after birth. The Apgar score ranges from 0 to 10, with higher scores indicating better condition. The proportion of neonates with Apgar \< 7 at 1 minute is also reported.
Time frame: At 1, 5, and 10 minutes after birth.
Post-delivery hs-CRP level
Post-delivery hs-CRP level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: mg/L.
Time frame: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
Post-delivery IL-6 level
Post-delivery IL-6 level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: pg/mL.
Time frame: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
Post-delivery cortisol level
Post-delivery cortisol level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: nmol/L.
Time frame: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
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