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The Effect of the Transversus Abdominis Plane Block to Postoperative Analgesia for Cesarean Section (TAP)

14. august 2018 opdateret af: Gia Dinh People Hospital

The Transversus Abdominis Plane Block

The transversus abdominis plane block (TAP block) has effect to postoperative analgesia for cesarean section with spinal anesthesia but it was limited for cesarean section with general anesthesia. The hypothesis that this technique has effect to postoperative analgesia for cesarean section with general anesthesia and it could reduce 50% of total morphine consumption during 24 hours after surgery.

Studieoversigt

Status

Afsluttet

Betingelser

Detaljeret beskrivelse

This is a randomized, controlled, no-blind clinical trial. The investigators selected 60 cases, who were cesarean section under general anesthesia, age from18 years, and American Society Anesthesiologists (ASA) classification was from II-III. The cases of acute fetal impairment, local anesthesia contraindication, tolerance opioids, liver failure, renal failure, and spinal anesthesia failure were excluded. All cases were randomized assigned two groups: the TAP block group (T group) and controlled group (C group). Each group has 30 cases. The TAP block was performed under the ultrasound guidance with 0.25% of ropivacaine 20 ml each side. The both groups was treated postoperative analgesia with intravenous morphine to patients controlled analgesia (PCA). The primary outcome was total morphine consumption during 24 hours after surgery. The secondary outcomes were the time of required the first dose of morphine, pain score, the complications of TAP block, the side effects of morphine, and satisfaction score of participants. Data was described and analyzed with SPSS 25.0. The sample size was calculated with the hypothesis that TAP block could reduce 50% of dose morphine during 24 hours after surgery, 80% of power, 10% of loss, and 0.05 of alpha error.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

60

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

      • Ho Chi Minh, Vietnam, 700000
        • THANG Nguyen Trong

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

18 år til 50 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Kvinde

Beskrivelse

Inclusion Criteria:

  • Cesarean section with general anesthesia.
  • The ASA classification was from II to III

Exclusion Criteria:

  • The acute fetal impairment.
  • The severe live or renal failure.
  • Tolerance opioids

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: T group
The TAP block group was called T group. The participants were performed TAP block under guidance at the end of surgery.
TAP block was performed under guidance with 0.25% ropivacaine 20 ml each side.
Andre navne:
  • Transversus abdominis plan blok
Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
Andre navne:
  • Opioider
Ropivacaine 0.25% 20 ml each side
Andre navne:
  • Anaropin
Placebo komparator: C group
The controlled group was called C group. The participants has not TAP block and were treated postoperative analgesia with intravenous morphine to patients controlled analgesia
Single dose was 1 mg. The locked time was 6 minutes. The limited dose was 40 mg/ 4 giờ.
Andre navne:
  • Opioider
Ropivacaine 0.25% 20 ml each side
Andre navne:
  • Anaropin

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Total morphine consumption during 24 hours
Tidsramme: 24 hours
Morphine was intravenous perfusion to participants during 24 hours with patients controlled analgesia (PCA).
24 hours

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
The time required the first of dose of morphine (hours)
Tidsramme: 24 hours
The time was from the end of surgery to the participants required the first of dose of morphine with PCA.
24 hours
Pain score: VAS
Tidsramme: 24 hours
Pain score was measured with visual analogue scale (VAS). VAS is from 0 to 10. The zero is complete non-pain and the ten is severe pain
24 hours
The rate of complications of TAP block
Tidsramme: 24 hours
There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall
24 hours
The rate of side effect of morphine
Tidsramme: 24 hours
There were rate of sedation, respiratory failure, nause and vomiting, pruritus
24 hours
The satisfaction of participants: Likert
Tidsramme: 24 hours
It was evaluated with Linkert score. Likerk score is from 1 to 5: 1-strongly disagree, 2-disagree, 3-neither agree nor disagree, 4-agree, 5-strongly agree
24 hours

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: THANG T Nguyen, Mr, Gia Dinh People 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)

10. juli 2017

Primær færdiggørelse (Faktiske)

15. juli 2017

Studieafslutning (Faktiske)

31. marts 2018

Datoer for studieregistrering

Først indsendt

12. august 2018

Først indsendt, der opfyldte QC-kriterier

14. august 2018

Først opslået (Faktiske)

16. august 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. august 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. august 2018

Sidst verificeret

1. august 2018

Mere information

Begreber relateret til denne undersøgelse

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