Efficacy of IV Acetaminophen for Pain Management
2 stycznia 2019 zaktualizowane przez: Aultman Health Foundation
Efficacy of IV Acetaminophen for Pain Management Following Major Gynecologic Surgery: Effect on Opioid Rescue, Return of Bowel Function, Cost and Length of Hospital Stay.
The investigators' goal in this planned prospective, randomized, patient blinded study is to compare our standard of care as the control group to an experimental group in which patients receive preemptive IV acetaminophen dosing that is continued every 6 hours for a total of 8 doses in patients who have undergone major gynecologic surgery.
The outcomes analyzed will include amount of rescue opioids required, time to return of bowel function, length of hospital stay, and patient satisfaction.
The hypothesis is that the addition of IV acetaminophen will decrease the need for opioid rescue and thereby decrease the incidence of associated gastrointestinal side effects including nausea, vomiting, bloating, and constipation.
The hope is that it will affect the final outcome of quicker return of bowel function, increased patient satisfaction, shortened hospital stay and prove to be an overall more effective postoperative pain management approach.
Przegląd badań
Status
Zakończony
Warunki
Interwencja / Leczenie
Szczegółowy opis
This is a patient-blinded prospective study in which patients that undergo major gynecologic surgery via an open abdominal approach will be randomized into two arms:
- Control Group: Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn. Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay. Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
- Experimental Group: Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn. IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction. Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Outcomes that will be analyzed include the amount of opioids used; time to return of bowel function designated as passage of flatus; time to first bowel movement if it occurs while inpatient; duration of hospital stay; and patient symptoms and satisfaction at the 24 and 48 hour marks as well as at time of discharge.
Typ studiów
Interwencyjne
Zapisy (Rzeczywisty)
68
Faza
- Faza 4
Kontakty i lokalizacje
Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.
Lokalizacje studiów
-
-
Ohio
-
Canton, Ohio, Stany Zjednoczone, 44720
- Aultman Health Foundation
-
-
Kryteria uczestnictwa
Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.
Kryteria kwalifikacji
Wiek uprawniający do nauki
18 lat do 85 lat (Dorosły, Starszy dorosły)
Akceptuje zdrowych ochotników
Nie
Płeć kwalifikująca się do nauki
Kobieta
Opis
Inclusion Criteria:
-Female patients undergoing major gynecologic surgery via an open abdominal approach. The included surgeries would be exploratory laparotomy with or without removal of uterus, fallopian tubes, or ovaries.
Exclusion Criteria:
- Patients with baseline preoperative liver function enzymes (AST and ALT) that are greater than twice the upper limit of normal would be excluded.
- Patients with baseline CrCl <30.
- Patients that require intensive postoperative care and delayed extubation will typically require additional sedation which would impede adequate evaluation of the two study pain regimens as they are designed to be patient controlled.
- Patients with complications unrelated to the pain regimens that prolong their stay would be excluded from the evaluation of hospital stay and cost effectiveness analyses. Examples would include but are not limited to pre-renal azotemia and acute renal failure; pneumonia; venous thromboembolism; or need for re-exploration laparotomy.
- Allergy to acetaminophen would exclude those patients set to enter the experimental IV acetaminophen study arm. One exception would be if the allergy were trivial and related to route of administration such as mild nausea with oral acetaminophen.
- Patients that undergo a bowel resection during surgery as it may adversely effect return of bowel function
- Patients that have required regular opioid intake for the 7 days preceding surgery.
- NSAIDs within 8 hours of surgery.
- Chronic steroid use with the exception of low-dose inhaled steroid formulations.
- Chronic alcohol or drug abuse.
- Patients currently pregnant.
- Patients unable to provide informed consent.
- Age >85
- Any physical, medical, and mental condition that would make participation in the study inadvisable.
Plan studiów
Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Podwójnie
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Komparator placebo: Experimental (Normal Saline)
Morphine patient-controlled-anesthesia (PCA) for the initial 24 hours post-operation with a low-dose basal rate (0.5mg/hr) and patient administered boluses prn.
Oral oxycodone from 24-48 hours post-operation will be used prn for pain and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
Normal saline 100cc IV will be infused as placebo every 6 hours for a total of eight doses with the first dose being given at time of anesthesia induction.
|
Normal saline (100cc) will be given IV as the placebo medication every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Inne nazwy:
|
|
Aktywny komparator: Experimental (IV Acetaminophen)
Morphine PCA for the initial 24 hours post-operation with low-dose basal rate (0.5mg/hr) with patient administered boluses prn.
IV acetaminophen 1,000mg will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Oral oxycodone from 24-48 hours post-operation will be used prn and then patients will be transitioned to oral combined oxycodone/acetaminophen for the remainder of their hospital stay.
|
IV acetaminophen (1,000mg) will be given every six hours for a total of eight doses with the first dose being given at time of anesthesia induction.
Inne nazwy:
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Opioid Rescue - 48 Hours
Ramy czasowe: First 48 hours including pre-operative and intra-operative medications
|
Mean number opioid rescue in the first 48 hours calculated by converting all opiates to intravenous morphine
|
First 48 hours including pre-operative and intra-operative medications
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Return of Bowel Function
Ramy czasowe: Duration of hospital stay (up to 7 days).
|
Time to return of bowel function (passage of flatus) in hours
|
Duration of hospital stay (up to 7 days).
|
|
Patient Satisfaction - Pain Control at 24 Hours, 48 Hours, and Discharge
Ramy czasowe: At 24 hours 48 hours, and discharge (up to 7 days)
|
Subjects will rate their overall satisfaction with pain control on a 5-point Likert scale: 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
|
At 24 hours 48 hours, and discharge (up to 7 days)
|
|
Patient Satisfaction - Nausea Control at 24 Hours, 48 Hours, and Discharge
Ramy czasowe: At 24 hours, 48 Hours, and Discharge (up to 7 days)
|
Subjects will rate their overall satisfaction with nausea control on a 5-point Likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
|
At 24 hours, 48 Hours, and Discharge (up to 7 days)
|
|
Patient Satisfaction - Bloating at 24 Hours, 48 Hours, and Discharge
Ramy czasowe: At 24 hours, 48 Hours, and Discharge (up to 7 days)
|
Subjects will rate their overall satisfaction with bloating on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
|
At 24 hours, 48 Hours, and Discharge (up to 7 days)
|
|
Patient Satisfaction - Pruritis at 24 Hours, 48 Hours, and Discharge
Ramy czasowe: At 24 hours, 48 Hours, and Discharge (up to 7 days)
|
Subjects will rate their overall satisfaction with pruritis control on a 5-point likert scale 1=Strongly disagree; 2=Disagree; 3=Neutral; 4=Agree; 5=Strongly Agree
|
At 24 hours, 48 Hours, and Discharge (up to 7 days)
|
|
Length of Stay
Ramy czasowe: Surgery to discharge
|
Mean length of post-operative stay in days
|
Surgery to discharge
|
Współpracownicy i badacze
Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.
Sponsor
Śledczy
- Główny śledczy: Laura K Randolph, DO, MS, Aultman Health Foundation
Daty zapisu na studia
Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
24 grudnia 2013
Zakończenie podstawowe (Rzeczywisty)
4 czerwca 2014
Ukończenie studiów (Rzeczywisty)
4 czerwca 2014
Daty rejestracji na studia
Pierwszy przesłany
2 stycznia 2014
Pierwszy przesłany, który spełnia kryteria kontroli jakości
6 stycznia 2014
Pierwszy wysłany (Oszacować)
7 stycznia 2014
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
16 stycznia 2019
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
2 stycznia 2019
Ostatnia weryfikacja
1 stycznia 2019
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 2013.08.22.F2
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .