- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03634111
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
Intervention / Behandling
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:
Single dose was 1 mg.
The locked time was 6 minutes.
The limited dose was 40 mg/ 4 giờ.
Andre navne:
Ropivacaine 0.25% 20 ml each side
Andre navne:
|
|
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:
Ropivacaine 0.25% 20 ml each side
Andre navne:
|
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.
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24 hours
|
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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
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24 hours
|
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The rate of complications of TAP block
Tidsramme: 24 hours
|
There were rate of systemic toxicity, puncture peritonea, and hematomae in abdominal wall
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24 hours
|
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The rate of side effect of morphine
Tidsramme: 24 hours
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There were rate of sedation, respiratory failure, nause and vomiting, pruritus
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24 hours
|
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The satisfaction of participants: Likert
Tidsramme: 24 hours
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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
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24 hours
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 11-2017/CN-HĐĐĐ
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