Effekten af ultralyd i realtid vejledningsteknik på effektiviteten og sikkerheden af arbejdsanalgesi
28. juli 2026 opdateret af: Zongxun Lin
Ultralyds-real-time vejledningsteknologi har store fordele i forhold til traditionel blind udforskningsteknologi med hensyn til nøjagtighed, succesrate og reduktion af punkteringsskader i intervertebralt rumpositionering gennem operationel visualisering, hvilket i høj grad forbedrer effektiviteten og sikkerheden af spinal blok.
På nuværende tidspunkt bruges Doppler-ultralyd sjældent til spinalblokade, især til ultralydsvejledningsteknologi i realtid, som ikke er blevet brugt bredt i klinisk praksis på grund af dets høje udstyrskrav, mangel på modne punkteringsplaner, komplekse operationer og høje indlæringskurve .
Hvis der kan udvikles en omfattende diagnose og behandlingsplan, vil det i høj grad forbedre fødeoplevelsen for mødre.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
Traditionel blind udforskning af rygmarvskanalpunktur har mange begrænsninger, hvilket ofte fremtvinger ændringer i anæstesimetoder på grund af flere punkteringsfejl.
Imidlertid kan anvendelsen af ultralydsvejledningsteknologi i realtid i rygmarvskanalpunktur fuldstændigt løse denne kliniske vanskelighed.
Den ultralyds-guidede real-time paramedian tilgang epiduralpunktur til arbejdsanalgesi er en ny type arbejdsanalgesiteknologi, og dens specifikke driftsstandarder og diagnostiske og behandlingsrutiner er endnu ikke etableret, herunder valg af punkturvej, punkturnålemodel, afstand mellem punkteringshul og epiduralt injektionspunkt, lægemiddeltype, dosering, opløselighed, volumen og andre parametre, som alle har stor forskningsplads.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
212
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
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Fujian
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Fuzhou, Fujian, Kina, 350001
- Fujian Provincial Hospital
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier:
- American Society of Anesthesiologists (ASA) Klasse I eller II;
- Enkelt sund graviditet;
- Hovedet vises først;
- 37 til 41 uger;
- Fødselsprocessen er aktiv, og livmoderhalsen udvider sig <5 cm;
- Kræv epidural arbejdsanalgesi;
- Meld dig frivilligt til at deltage i denne undersøgelse og underskriv en informeret samtykkeformular.
Ekskluderingskriterier:
- Tilstedeværelse af graviditetssygdomme, såsom graviditetshypertension, præeklampsi, graviditetsdiabetes;
- Kontraindikationer til intraspinal analgesi: 1) Centralnervesystemets sygdomme. 2) Infektion eller septikæmi på stikstedet. 3) Koagulationsdysfunktion;
- Kendte tilfælde af føtal misdannelse eller øget risiko for kejsersnit, såsom en historie med livmoderruptur;
- Personer med en historie med psykisk sygdom, hysteri, epilepsi osv., som ikke kan samarbejde.
- Patienter med langvarig brug af opioider, steroider og kroniske smerter.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Ultralyd Real-time Guidance kombineret med Dural Puncture Epidural Group
Ultralyd vejledning i realtid kombineret med dural punktur epidural Kan forbedre den kliniske effekt af fødselsanalgesi.
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Ultralyds-real-time vejledningsteknologi har store fordele i forhold til traditionel blind udforskningsteknologi med hensyn til nøjagtighed, succesrate og reduktion af punkteringsskader i intervertebralt rumpositionering gennem operationel visualisering, hvilket i høj grad forbedrer effektiviteten og sikkerheden af spinal blok.
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Aktiv komparator: Dural punktering epidural gruppe
Dural punktur epidural er en klinisk forbedring af kombineret spinal-epidural og er meget udbredt til moder.
Implementeringstrinnet er at fuldføre epiduralpunkturen, midlertidigt ikke placere en sonde, punktere dura mater med en subarachnoid anæstesi-nål, men ikke direkte injicere lægemidler i det subarachnoidale rum, og derefter lade et epiduralkateter stå til administration i henhold til epiduralblokade .
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Dural punktur epidural er en klinisk forbedring af kombineret spinal-epidural og er meget udbredt til moder.
Implementeringstrinnet er at fuldføre epiduralpunkturen, midlertidigt ikke placere en sonde, punktere dura mater med en subarachnoid anæstesi-nål, men ikke direkte injicere lægemidler i det subarachnoidale rum, og derefter lade et epiduralkateter stå til administration i henhold til epiduralblokade .
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Composite endpoint of labor analgesia outcome
Tidsramme: 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). |
From initiation of labor analgesia to delivery (assessed up to 24 hours).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Time to analgesia onset
Tidsramme: 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.
|
Within 30 minutes after initial drug administration.
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Visual Analogue Scale (VAS) score
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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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.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Number of patient-controlled analgesia (PCA) demands
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Number of PCA bolus demands during labor analgesia.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Local anesthetic consumption
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
|
Per-minute local anesthetic consumption during labor analgesia.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Sensory blockade level
Tidsramme: During the labor analgesia period (assessed up to 24 hours).
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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.
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During the labor analgesia period (assessed up to 24 hours).
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Incidence of asymmetric block
Tidsramme: During the labor analgesia period (assessed up to 24 hours).
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Defined as a ≥ 2-dermatome difference in sensory blockade level between the left and right sides.
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During the labor analgesia period (assessed up to 24 hours).
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Sensory blockade at the second sacral dermatome (S2)
Tidsramme: During the labor analgesia period (assessed up to 24 hours).
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S2 sensory blockade categorized as bilateral, unilateral, or none.
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During the labor analgesia period (assessed up to 24 hours).
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Number of Participants with Physician Interventions
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Physician interventions including analgesic regimen adjustments, epidural catheter repositioning, and re-puncture.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Modified Bromage score
Tidsramme: During the labor analgesia period (assessed up to 24 hours).
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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.
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During the labor analgesia period (assessed up to 24 hours).
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Side effects of labor analgesia
Tidsramme: From analgesia initiation until delivery and postpartum (assessed up to 72 hours).
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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.
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From analgesia initiation until delivery and postpartum (assessed up to 72 hours).
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Cesarean delivery rate and indications
Tidsramme: At delivery.
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Rate of cesarean delivery and indications for cesarean delivery (non-reassuring fetal heart rate, arrest of descent, maternal indications, other).
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At delivery.
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Mean uterine contraction frequency
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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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
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Mean single uterine contraction duration
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Time-weighted mean single uterine contraction duration, derived from area under the curve (AUC) calculation from analgesia to delivery.
Unit of measure: seconds.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Incidence of uterine hypertonia
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Defined as a single contraction lasting > 2 min.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Incidence of uterine tachysystole
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Defined as > 5 contractions per 10 min.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
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Duration of each stage of labor
Tidsramme: From labor onset to delivery of the placenta (assessed up to 24 hours).
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Duration of the first, second, third, and total stages of labor.
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From labor onset to delivery of the placenta (assessed up to 24 hours).
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Maternal body temperature
Tidsramme: Pre-analgesia and at delivery.
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Maternal body temperature before analgesia and at delivery.
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Pre-analgesia and at delivery.
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NICHD fetal heart rate tracing classification
Tidsramme: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
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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.
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From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
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NICHD category progression rate
Tidsramme: From baseline (pre-analgesia) through delivery (assessed up to 24 hours).
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Proportion of parturients whose NICHD category worsened from baseline during labor analgesia.
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From baseline (pre-analgesia) through delivery (assessed up to 24 hours).
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Fetal heart rate
Tidsramme: 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.
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From initiation of labor analgesia to delivery (assessed up to 24 hours).
|
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Fetal heart rate decelerations
Tidsramme: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
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Types of fetal heart rate decelerations (early, late, variable).
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From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
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Fetal heart rate variability
Tidsramme: From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
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Fetal heart rate variability categorized as absent, minimal, moderate, or marked.
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From the baseline assessment (pre-analgesia) through delivery (assessed up to 24 hours).
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Neonatal Apgar scores
Tidsramme: At 1, 5, and 10 minutes after birth.
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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.
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At 1, 5, and 10 minutes after birth.
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Post-delivery hs-CRP level
Tidsramme: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
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Post-delivery hs-CRP level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA).
Unit of measure: mg/L.
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Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
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Post-delivery IL-6 level
Tidsramme: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
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Post-delivery IL-6 level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA).
Unit of measure: pg/mL.
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Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
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Post-delivery cortisol level
Tidsramme: Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
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Post-delivery cortisol level in venous blood, adjusted for pre-delivery baseline value using analysis of covariance (ANCOVA).
Unit of measure: nmol/L.
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Pre-delivery (baseline, within 1 week before delivery) and 30 minutes after delivery.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Zongxun Lin, Master, Fujian Provincial Hospital
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
1. april 2024
Primær færdiggørelse (Faktiske)
31. december 2025
Studieafslutning (Faktiske)
31. december 2025
Datoer for studieregistrering
Først indsendt
1. marts 2024
Først indsendt, der opfyldte QC-kriterier
7. marts 2024
Først opslået (Faktiske)
8. marts 2024
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
30. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
28. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Ultrasound Real-time Guidance
Plan for individuelle deltagerdata (IPD)
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