Effekten av ultralyd sanntidsveiledningsteknikk på effektiviteten og sikkerheten til analgesi
Studieoversikt
Status
Status
Forhold
Forhold
Intervensjon / Behandling
Intervensjon / Behandling
Detaljert beskrivelse
Studietype
Studietype
Registrering (Faktiske)
Registrering
Fase
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
Studiekontakt
- Navn: Zongxun Lin, Master
- Telefonnummer: +8613763820916
- E-post: 13763820916@189.cn
Studiesteder
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Fujian
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Fuzhou, Fujian, Kina, 350001
- Fujian Provincial Hospital
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Deltakelseskriterier
Kvalifikasjonskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier:
- American Society of Anesthesiologists (ASA) Klasse I eller II;
- Enkelt sunt svangerskap;
- Hodet vises først;
- 37 til 41 uker;
- Arbeidsprosessen er aktiv, og livmorhalsen utvider seg <5 cm;
- Krev epidural arbeidsanalgesi;
- Meld deg frivillig til å delta i denne studien og signer et informert samtykkeskjema.
Ekskluderingskriterier:
- Tilstedeværelse av svangerskapssykdommer, slik som svangerskapshypertensjon, svangerskapsforgiftning, svangerskapsdiabetes;
- Kontraindikasjoner for intraspinal analgesi: 1) Sykdommer i sentralnervesystemet. 2) Infeksjon eller septikemi på stikkstedet. 3) Koagulasjonsdysfunksjon;
- Kjente tilfeller av fostermisdannelse eller økt risiko for keisersnitt, for eksempel en historie med livmorruptur;
- Personer med tidligere psykiske lidelser, hysteri, epilepsi osv. som ikke kan samarbeide.
- Pasienter med langvarig bruk av opioider, steroider og kroniske smerter.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Antall våpen
Våpen og intervensjoner
Deltakergruppe / ArmDeltakergruppe / Arm |
Intervensjon / BehandlingIntervensjon / Behandling |
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Eksperimentell: Ultralyd Sanntidsveiledning kombinert med Dural Puncture Epidural Group
Ultralyd sanntidsveiledning kombinert med dural punktering epidural Kan forbedre den kliniske effekten av arbeidsanalgesi.
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Ultralyd sanntidsveiledningsteknologi har store fordeler i forhold til tradisjonell blindutforskningsteknologi når det gjelder nøyaktighet, suksessrate og reduksjon av punkteringsskade i intervertebral plassposisjonering gjennom operasjonell visualisering, noe som i stor grad forbedrer effektiviteten og sikkerheten til spinalblokk.
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Aktiv komparator: Dural punktering epidural gruppe
Dural punktering epidural er en klinisk forbedring av kombinert spinal-epidural og er mye brukt hos mor.
Implementeringstrinnet er å fullføre epiduralpunkturen, midlertidig ikke plassere en sonde, punktere dura mater med en subaraknoidal anestesi-nål, men ikke injisere medikamenter direkte inn i subaraknoidalrommet, og deretter la et epiduralkateter for administrering i henhold til epiduralblokkering .
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Dural punktering epidural er en klinisk forbedring av kombinert spinal-epidural og er mye brukt hos mor.
Implementeringstrinnet er å fullføre epiduralpunkturen, midlertidig ikke plassere en sonde, punktere dura mater med en subaraknoidal anestesi-nål, men ikke injisere medikamenter direkte inn i subaraknoidalrommet, og deretter la et epiduralkateter for administrering i henhold til epiduralblokkering .
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Hva måler studien?
Primære resultatmål
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Composite endpoint of labor analgesia outcome
Tidsramme: From initiation of labor analgesia to delivery (assessed up to 24 hours).
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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).
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Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time to analgesia onset
Tidsramme: Within 30 minutes after initial drug administration.
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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.
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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).
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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).
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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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Samarbeidspartnere og etterforskere
Sponsor
Sponsor
Etterforskere
Etterforskere
- Hovedetterforsker: Zongxun Lin, Master, Fujian Provincial Hospital
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Studiestart
Primær fullføring (Faktiske)
Primær fullføring
Studiet fullført (Faktiske)
Studiet fullført
Datoer for studieregistrering
Først innsendt
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Først lagt ut
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Sist oppdatering lagt ut
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Sist bekreftet
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