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IV Acetaminophen for Postoperative Pain Analgesia After Laparoscopic Hysterectomy

15 mei 2018 bijgewerkt door: Noah Rindos, University of Pittsburgh

Intravenous Acetaminophen Versus Saline in Postoperative Analgesia After Laparoscopic Hysterectomy: A Randomized, Double Blind, Placebo Controlled Trial

The objective of this study is to quantify the change in post-operative pain scores and narcotic requirements in women receiving pre and post-operative IV acetaminophen compared to placebo in women undergoing laparoscopic hysterectomy.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

Gynecologic surgery has been revolutionized by the incorporation of minimally invasive techniques. Procedures that once resulted in multiple day hospital admissions are now being performed in outpatient surgery centers. Common factors that contribute to delayed discharge are inadequate postoperative pain control and increased nausea and vomiting. A multi-modal pain management approach is considered optimal at controlling postsurgical pain, which includes combining different analgesics that act in varying mechanisms. By using medications that act synergistically, the overall analgesia requirement can oftentimes be decreased.

Opioids have been found to be highly effective in controlling postoperative pain; however, are associated with dose-dependent risks including nausea, vomiting, constipation, urinary retention, sedation, and respiratory depression. Subsequently, non-opioid options are frequently desired in an attempt to minimize narcotic intake. In the United States, intravenous acetaminophen was approved by the US Food and Drug Administration (FDA) in November 2010 for the management of mild to moderate pain and the reduction of fever. Since this time, multiple studies have analyzed the role of intravenous acetaminophen in both acute and postoperative pain; however, none have been specific to laparoscopic hysterectomy. The primary study published evaluating intravenous acetaminophen in laparoscopic hysterectomies also included multiple other laparoscopic procedures from a variety of specialties including general surgery, urology, and urogynecology. In addition, the intravenous acetaminophen was started on average 19 hours after the conclusion of the case once the patient controlled analgesic was discontinued.

Improved postsurgical pain control achieved with intravenous acetaminophen may potentially lead to same day discharge after major laparoscopic gynecologic procedures. Same day discharge after laparoscopic hysterectomy has been shown to be a safe option with proper patient counseling and multi-modal pain medications. In addition, same day discharge is also associated with decreased health care expenditures. With continued efforts to cut hospital costs, the pressure to discharge patients earlier continues to be high.

The investigators propose that intravenous acetaminophen will improve post-operative pain control and decrease narcotic requirements for patients undergoing laparoscopic hysterectomies. Furthermore, The investigators expect to find decreased postsurgical nausea and vomiting and potentially quicker discharge to home. This could have a large impact on the field of gynecologic surgery as major procedures that once required overnight admission may now succeed at same day discharge.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

183

Fase

  • Fase 4

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Verenigde Staten
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15213
        • Magee Womens Hospital

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 75 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

Inclusion Criteria:

  • Women aged 18-75
  • Ability to read and write in English (our post-operative pain log is only available in English)
  • Planning a laparoscopic hysterectomy (includes total laparoscopic hysterectomy, laparoscopic supracervical hysterectomy, laparoscopically assisted vaginal hysterectomy, with or without salpingooophorectomy)

Exclusion Criteria:

  • Answering yes to any of the following questions: "Do you have a history of liver disease, kidney disease, hepatitis C, history of liver failure, greater than 3 drinks per day or being have you ever been told by your doctor that they should not take acetaminophen"
  • History of cardiac arrhythmia
  • History of jaundice
  • Acute abdominal inflammatory or infectious process at time of surgery
  • Known malignancy at time of surgery
  • Known pregnancy at time of surgery
  • Plan to perform additional significant surgical procedure at the time of hysterectomy such as extensive excision of endometriosis on bowel or bladder or pelvic reconstructive procedure
  • >6cm abdominal incision in order to remove the uterus at time of study-related hysterectomy
  • Regular use of narcotic pain medication (defined as use on most days of the week at any point in the past 3 months)
  • Allergy to acetaminophen
  • Women who weigh less than 50 kilograms on the day of surgery.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Verdrievoudigen

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intravenous IV acetaminophen
The patients in the treatment arm will receive 1000mg of IV acetaminophen.
Geneesmiddel: IV acetaminophen
The patients in the treatment arm will receive 1000mg of IV acetaminophen.
Andere namen:
  • OFIRMEV
Placebo-vergelijker: Normal Saline
The patients in the placebo arm will receive normal saline.
Geneesmiddel: placebo
The patients in the placebo arm will receive normal saline.
Andere namen:
  • Normale zoutoplossing

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Postoperative Pain
Tijdsspanne: 24 hours
The primary aim of this study is to compare overall post-surgical pain after hysterectomy as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no pain at all and 10 is the worst pain that a person can imagine. Less pain is considered preferable to more pain. The theory is that patients who have intravenous acetaminophen will report less post-surgical pain.
24 hours

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Narcotic Medication Use
Tijdsspanne: 24 hours
The secondary outcome is comparison of narcotic pain medical requirements within the first 24 hours after surgery. The hypothesis is that the intravenous acetaminophen group will require less narcotic medications than the placebo group. Narcotic use in this study will be calculated by converting all narcotics (fentanyl, dilaudid etc) into standardized units of morphine using well validated conversion tables.
24 hours

Andere uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Having a Feeling of General Well-being at One Month
Tijdsspanne: 4 weeks
Quality of recovery will be evaluated through the use of the validated Quality of Recovery-40 questionnaire. The hypothesis is that the intravenous acetaminophen group will experience an increased quality of recovery as compared to the placebo group.
4 weeks
Number of Participants Who Vomited Within 24 Hours of Operation
Tijdsspanne: 24 hours
A secondary aim of this study is to compare post-operative vomiting scores on post-operative day zero and one. Vomiting is reported as either having vomited or not vomited. The hypothesis is that the intravenous acetaminophen group will experience decreased vomiting compared with the placebo group.
24 hours
Readiness for Discharge
Tijdsspanne: 24 hours
Patient perception of satisfaction at time of discharge on post-operative day zero will be evaluated. The hypothesis is that intravenous acetaminophen group will experience increased satisfaction for discharge than the placebo group.
24 hours
Nausea Before Surgery as Compared to After Surgery
Tijdsspanne: 24 hours
A secondary aim of this study is to compare post-operative nausea on post-operative day zero and one as reported by the patients on a visual analog scale with a range of 0 to 10 where 0 is no nausea at all and 10 is the worst nausea that a person can imagine. Less nausea is considered preferable to more nausea. The hypothesis is that the intravenous acetaminophen group will experience decreased nausea compared with the placebo group.
24 hours

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Pittsburgh

Onderzoekers

  • Hoofdonderzoeker: Noah Rindos, MD, Faculty

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 februari 2015

Primaire voltooiing (Werkelijk)

1 september 2016

Studie voltooiing (Werkelijk)

1 september 2016

Studieregistratiedata

Eerst ingediend

18 maart 2015

Eerst ingediend dat voldeed aan de QC-criteria

26 maart 2015

Eerst geplaatst (Schatting)

27 maart 2015

Updates van studierecords

Laatste update geplaatst (Werkelijk)

13 juni 2018

Laatste update ingediend die voldeed aan QC-criteria

15 mei 2018

Laatst geverifieerd

1 mei 2018

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • PRO13110403

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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