Labor Analgesia
Conditions
Keywords
Ultrasound Real-time Guidance, labor analgesia, delivery woman, neonate, Effectiveness, Safety
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.
Interventions
DEVICEUltrasound Real-time Guidance combined with Dural Puncture Epidural Labor Analgesia
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.
DEVICEDural Puncture Epidural Labor Analgesia
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.
Sponsors
Zongxun Lin
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 45 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite endpoint of labor analgesia outcome | 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
| Measure | Time frame | Description |
|---|---|---|
| Time to analgesia onset | Within 30 minutes after initial drug administration. | 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. |
| Visual Analogue Scale (VAS) score | From initiation of labor analgesia to delivery (assessed up to 24 hours). | 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. |
| Number of patient-controlled analgesia (PCA) demands | From initiation of labor analgesia to delivery (assessed up to 24 hours). | Number of PCA bolus demands during labor analgesia. |
| Local anesthetic consumption | From initiation of labor analgesia to delivery (assessed up to 24 hours). | Per-minute local anesthetic consumption during labor analgesia. |
| Sensory blockade level | During the labor analgesia period (assessed up to 24 hours). | 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. |
| Incidence of asymmetric block | During the labor analgesia period (assessed up to 24 hours). | Defined as a ≥ 2-dermatome difference in sensory blockade level between the left and right sides. |
| Sensory blockade at the second sacral dermatome (S2) | During the labor analgesia period (assessed up to 24 hours). | S2 sensory blockade categorized as bilateral, unilateral, or none. |
| Number of Participants with Physician Interventions | From initiation of labor analgesia to delivery (assessed up to 24 hours). | Physician interventions including analgesic regimen adjustments, epidural catheter repositioning, and re-puncture. |
| Modified Bromage score | During the labor analgesia period (assessed up to 24 hours). | 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. |
| Side effects of labor analgesia | From analgesia initiation until delivery and postpartum (assessed up to 72 hours). | 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. |
| Cesarean delivery rate and indications | At delivery. | Rate of cesarean delivery and indications for cesarean delivery (non-reassuring fetal heart rate, arrest of descent, maternal indications, other). |
| Mean uterine contraction frequency | From initiation of labor analgesia to delivery (assessed up to 24 hours). | 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 |
| Mean single uterine contraction duration | From initiation of labor analgesia to delivery (assessed up to 24 hours). | Time-weighted mean single uterine contraction duration, derived from area under the curve (AUC) calculation from analgesia to delivery. Unit of measure: seconds. |
| Incidence of uterine hypertonia | From initiation of labor analgesia to delivery (assessed up to 24 hours). | Defined as a single contraction lasting \> 2 min. |
| Incidence of uterine tachysystole | From initiation of labor analgesia to delivery (assessed up to 24 hours). | Defined as \> 5 contractions per 10 min. |
| Duration of each stage of labor | From labor onset to delivery of the placenta (assessed up to 24 hours). | Duration of the first, second, third, and total stages of labor. |
| Maternal body temperature | Pre-analgesia and at delivery. | Maternal body temperature before analgesia and at delivery. |
| NICHD fetal heart rate tracing classification | From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours). | 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. |
| NICHD category progression rate | From baseline (pre-analgesia) through delivery (assessed up to 24 hours). | Proportion of parturients whose NICHD category worsened from baseline during labor analgesia. |
| Fetal heart rate | From initiation of labor analgesia to delivery (assessed up to 24 hours). | Time-weighted mean fetal heart rate from analgesia to delivery, derived from area under the curve (AUC) calculation. |
| Fetal heart rate decelerations | From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours). | Types of fetal heart rate decelerations (early, late, variable). |
| Fetal heart rate variability | From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours). | Fetal heart rate variability categorized as absent, minimal, moderate, or marked. |
| Neonatal Apgar scores | At 1, 5, and 10 minutes after birth. | 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. |
| Post-delivery hs-CRP level | Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery. | Post-delivery hs-CRP level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: mg/L. |
| Post-delivery IL-6 level | Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery. | Post-delivery IL-6 level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: pg/mL. |
| Post-delivery cortisol level | Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery. | Post-delivery cortisol level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA). Unit of measure: nmol/L. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORZongxun Lin, Master
Fujian Provincial Hospital
Outcome results
None listed