- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03808129
Erector Spinae Plane Block for Peroperative Analgesia and Intraabdominal Tissue Oxygenation (ESPB)
19. mars 2020 oppdatert av: Bezmialem Vakif University
The Evaluation of Ultrasonography-guided Erector Spinae Plane Block in Perioperative Analgesia and Intraabdominal Tissue Oxygenation in Pediatric Patients Undergoing Lower Abdominal Surgery
Brief summary: Regional anesthesia decreases the need for intravenous analgesia in the peri-operative period.
Erector spinae plane (ESP) is a regional anesthesia technique shown to be effective at the dorsal and ventral rami of the thoracic spinal nerve along with sympathetic nerve fibers.
The purpose is to demonstrate the contribution of ESP block to the postoperative analgesia by ultrasonography and to increase intraabdominal tissue oxygenation compared to the control group.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
50 patients with American Society of Anesthesiologists (ASA) physical score I-II were randomly divided into 25 patients in the ESP group and 25 patients in the control group.
Patients were premedicated with oral midazolam 0.5 mg kg-1, 30 minutes before surgery Anesthesia monitorization was made with electrocardiogram, non-invasive blood pressure, peripheral oxygen saturation (SpO2), end-tidal carbon dioxide, temperature, Bispectral index (BIS), and Regional tissue saturation (rSO2).
Anesthesia was induced with a face mask distributing 8% sevoflurane and 50% air in oxygen while the patients were breathing spontaneously.
After anesthesia induction, peripheral venous access was established and propofol 2 mg kg-1 and fentanyl citrate 1 μg kg-1 were administered.
Laryngeal mask airways were used to secure the upper airways.
Anesthesia was maintained with sevoflurane and 50% air in oxygen.
The concentration of sevoflurane was adjusted by targeting BIS scores at 50-60 in all groups.
During the operations, fentanyl was administered at a dose of 0.5 μg kg-1 if the blood pressure and heart rates were 20% higher than the baseline value.
In ESP blok groups, after general anesthesia induced, patients were placed in the lateral position and ESP block was performed under ultrasound guidance.
For ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine was administered.
In all groups, regional tissue saturation (RSO2) was evaluated Continuously with near infrared spectroscopy (NIRS) probe from anesthesia induction to the end of surgery.
Commercially available device (INVOS Cerebral Oximeter; somatics Corp, Troy, Mich) was used to monitor rSO2 values in the surgery side flank during surgical intervention.
Pain was evaluated and recorded using the FLACC (Face, Legs, Activity, Cry, Consolability) scale at the 1st, 2nd, 8th, 12th and 24th hours.
Total analgesic consumption was recorded during the operation and postoperative time to first analgesic drug and number of patients who required analgesic in the first 24 hours, parents satisfaction score, discharge time as well as adverse effects such as nausea and vomiting were recorded in the postoperative periods.
Studietype
Intervensjonell
Registrering (Faktiske)
49
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
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Istanbul, Tyrkia, 34093
- Parvin Pinar
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 måneder til 2 år (Barn)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- Children aged 6 months to 2 years
- According to American Anesthesia Society Anesthesia Risk Scale ASA I-II class patients
- Patients with lower abdominal surgery
Exclusion Criteria:
- Children under 6 months and older than 2 years
- According to American Anesthesia Society Anesthesia Risk Scale Patients with ASA III-IV class
- Patients with contraindication to regional anesthesia
- Patients with a history of local anesthetic allergy
- Patients with abnormal coagulation profile
- Patients with infection at the injection site
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Aktiv komparator: ESP Group: Bupivacaine and lidocaine
ESP Group: Bupivacaine and lidocaine: Erector Spinae Plane Block : (1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine) was administered.
|
ESP block was administered under general anesthesia before the surgery.
Patients with ESP block, 1: 1 ratio of 0.25% bupivacaine and 0.4 ml / kg of 1% lidocaine
Andre navn:
|
Ingen inngripen: control group
Control Group:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
FLACC scale
Tidsramme: From recovery of anesthesia to end of study ( postoperative 24 hours)
|
FLACC scale was used.
The Face, Legs, Activity, Cry, Consolability scale (FLACC) scale was a measurement used to assess pain for children between the ages of 6 months and 2 years or individuals that are unable to communicate their pain.
The scale is scored in a range of 0-10 with 0 representing no pain.
The scale has five criteria, which are each assigned a score of 0, 1 or 2.
|
From recovery of anesthesia to end of study ( postoperative 24 hours)
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NIRS
Tidsramme: Before anesthesia induction to end of operation ( intraoperative 2 hours )
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INVOS ;Somatic Corp, Troy, Mic sensors placed in surgical side of patients was used to detect peripheral perfusion and oxygen delivery (rSo2)
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Before anesthesia induction to end of operation ( intraoperative 2 hours )
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Time to first analgesic drug
Tidsramme: first 24 hour
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Time to first analgesic drug will be recorded
|
first 24 hour
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Need for analgesic
Tidsramme: first 24 hour
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Number of patients who required analgesic in the first 24 hour
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first 24 hour
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: PARVIN PINAR, Bezmialem Vakif University
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
18. januar 2019
Primær fullføring (Faktiske)
12. april 2019
Studiet fullført (Faktiske)
20. april 2019
Datoer for studieregistrering
Først innsendt
13. desember 2018
Først innsendt som oppfylte QC-kriteriene
15. januar 2019
Først lagt ut (Faktiske)
17. januar 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
20. mars 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. mars 2020
Sist bekreftet
1. mars 2020
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Sensoriske systemagenter
- Bedøvelsesmidler
- Membrantransportmodulatorer
- Anestesimidler, lokal
- Spenningskontrollerte natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
- Bupivakain
Andre studie-ID-numre
- P0001
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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