- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02043704
RCT (Randomized Controlled Trial) of IV Acetaminophen for Post Operative Vaginal Reconstruction Pain
19. juli 2018 opdateret af: TriHealth Inc.
The Effect of Intravenous Acetaminophen on Post-operative Pain and Narcotic Consumption in Vaginal Reconstructive Surgery Patients: A Randomized Controlled Trial
This randomized controlled trial will evaluate the effects of perioperative intravenous (IV) acetaminophen on postoperative narcotic consumption and pain scores in subjects undergoing vaginal reconstructive surgery.
One hundred subjects will be randomly assigned to receive either IV acetaminophen or IV placebo.
Those in the IV acetaminophen group will receive 1000mg IV every 6 hours for 24 hours beginning prior to anesthesia induction.
The control group will receive placebo saline infusions at the same time intervals.
All subjects will receive as needed (prn) IV narcotic for additional pain relief.
Visual analog scales (VAS) regarding pain will be evaluated at 18 and 24 hours postoperative and immediately prior to discharge.
We will also collect total IV narcotic consumption.
We hypothesize that subjects receiving IV acetaminophen will have lower VAS scores and decreased total narcotic consumption in comparison to the control group.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
see brief summary
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
100
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45220
- TriHealth - Good Samaritan and Bethesda North Hospitals
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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
18 år til 70 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- Women between the ages of 18 and 70 years
- Patients of the Division of Urogynecology at Good Samaritan and Bethesda North Hospitals in Cincinnati, Ohio
- Scheduled to undergo major vaginal reconstruction
- Must undergo total vaginal hysterectomy, anterior repair, posterior repair, enterocele repair, and intraperitoneal vault suspension. The addition of suburethral sling is not a cause for exclusion.
Exclusion Criteria:
- Allergy to acetaminophen
- Liver disease (chronic or active)
- Chronic alcohol use (>1 drink/day)
- Bleeding diathesis
- Renal disease
- Opiate dependent or daily use
- History of chronic pain
- Mental or cognitive disorder preventing patient to accurately verbalize pain levels
- Undergoing abdominal or laparoscopic procedures at the time of surgery
- Allergy to hydromorphone
- Surgery is not performed under general anesthesia
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: IV Acetaminophen
Subjects will receive a 1000mg dose of IV acetaminophen in 100mL solution every 6 hours for 24 hours.
The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision.
A total of 4 doses will be given.
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Details covered in arm description.
Andre navne:
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Placebo komparator: Saline
Subjects will receive a 100mL dose of IV saline every 6 hours for 24 hours.
The first dose will be administered prior to anesthesia induction, approximately 30 minutes before skin incision.
A total of 4 doses will be given.
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Details covered in arm description.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain While Active - 18 hr
Tidsramme: 18 hours
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Post operative pain will be assessed 18 hours after surgery.
Pain will be self reported by patients using a 0-100 mm visual analog scale (VAS) with 0 indicating no pain and 100 indicating the worst pain imaginable.
A pain score will be collected for pain while active.
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18 hours
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Total Amount of Narcotic Consumption in the First 24 Hours Post Surgery
Tidsramme: 24 hours
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Hydromorphone will be administered for breakthrough pain.
The total amount consumed in the first 24 hours post surgery will be recorded.
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24 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for nausea/vomiting.
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24 hours
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Time to First Rescue Narcotic
Tidsramme: 24 hours
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The time from the end of surgery to the time any IV narcotic is given.
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24 hours
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Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for itching.
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24 hours
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Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for headache.
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24 hours
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Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for insomnia.
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24 hours
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Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for rash/hives.
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24 hours
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Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for shortness of breath.
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24 hours
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Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for respiratory depression.
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24 hours
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Narcotic Associated Side Effects
Tidsramme: 24 hours
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The incidence of known narcotic associated side effects will be recorded for urinary retention.
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24 hours
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Time to Ambulation
Tidsramme: 1800 minutes
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Length of time from the end of surgery to the time of ambulation.
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1800 minutes
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Time to First Flatus/Bowel Movement
Tidsramme: 9000 minutes
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Length of time from the end of surgery to the time of first flatus or bowel movement.
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9000 minutes
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
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
1. januar 2014
Primær færdiggørelse (Faktiske)
1. august 2016
Studieafslutning (Faktiske)
1. august 2016
Datoer for studieregistrering
Først indsendt
21. januar 2014
Først indsendt, der opfyldte QC-kriterier
21. januar 2014
Først opslået (Skøn)
23. januar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
16. august 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
19. juli 2018
Sidst verificeret
1. februar 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 13072
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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