Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion
22. april 2020 opdateret af: Texas Tech University Health Sciences Center
Postoperative Opioid Use and Pain Scores in Patients Undergoing Transforaminal Lumbar Interbody Fusion After Administration of Preoperative Followed by Scheduled Intravenous Acetaminophen:
The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
The purpose of this project is to study the effects of preoperative followed by scheduled intravenous acetaminophen on pain control for 24 hours postoperatively after minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. The advantages of intravenous acetaminophen are well known in the literature and its opioid-sparing effects have been documented in multiple surgical studies.
Multimodal regimens are now being advocated in the literature to decrease opioid use (8, 23). This is especially significant in spine surgery patients who often have chronic pain requiring long-term use of these habit-forming drugs as well as in patients who may not be able to tolerate opiods due to health status.
To our knowledge there are no studies done in the U.S. on the opioid sparing and pain reducing effects of intravenous acetaminophen on patients undergoing elective minimally invasive 1 or 2 level transforaminal lumbar interbody fusion. Investigating intravenous acetaminophen, particularly its pain reducing and opioid sparing effects, may give surgeons another medication for use in a multimodal approach to pain.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
21
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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Texas
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Lubbock, Texas, Forenede Stater, 79430
- Texas Tech University Health Science Center
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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 og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- Age > 18 years old
- Being scheduled to have elective primary minimally invasive 1 or 2 level transforaminal lumbar laminectomy interbody fusion
- ASA I, II, or III
- Informed consent form signed
Exclusion Criteria:
- Anyone weighing less than 50kg (as this would require a dosing change).
- Hypersensitivity or contraindication to intravenous acetaminophen or opioids
- Allergy to Methocarbamol; morphine sulfate, sevoflourane, or fentanyl
- Impairment of liver function-- defined as the inability to receive intravenous acetaminophen without dose adjustment as determined by the investigator; or history of chronic liver disease defined as history of hepatitis of any kind as recorded in the patient's chart
- Mental retardation recorded as a diagnosis in the patient's chart
- History of chronic pain (defined as currently receiving treatment from a specialist for pain)
- History of pain recalcitrant to intravenous morphine
- Impaired kidney function (defined as creatinine > 1.5)
- Anyone who is not a candidate for general anesthesia or any other portion of the investigator's standard of
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Aktiv komparator: acetaminophen
1g intravenous acetaminophen over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours; maximum dose of 4 grams in 24 hours
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1 gram of intravenous Acetaminophen
Andre navne:
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Placebo komparator: PlaceboComparator
Placebo Comparator 0.9% NaCl 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
|
placebo comparator .9%
NaCl (sodium chloride) 100 mL over will be administered intravenously over a period of 15 minutes, 15 minutes (+/- 10 minutes) prior to the anticipated time of incision and every 6 hours (+/- 30 minutes) after the initial dose for 24 hours
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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VAS
Tidsramme: Q4 x 24 hours averaged
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The Visual Analogue Scale (VAS) and Verbal Rating Scale (VRS) will be measured at 4 hour intervals for a 24-hr period - measures of pain intensity in clinical and research settings.
0-10 Numeric pain intensity scale.
0 is no pain, 5 is moderate pain, and 10 is worst possible pain
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Q4 x 24 hours averaged
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Level of 100% Sedation
Tidsramme: 4-hr intervals for a 24-hr period averaged
|
Sedation will be measured on a scale of 1 to 5 at 4-hour intervals as follows: 1-completely awake; 2-awake but drowsy; 3 asleep, but responds to verbal commands; 4-asleep but responds to tactile stimuli; and 5-asleep and not responding to any stimuli.
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4-hr intervals for a 24-hr period averaged
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Vital Signs
Tidsramme: 4-hour intervals (+/- 30 minutes) for 24-hrs averaged
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Routine postoperative vital signs will be collected at 4-hour intervals (+/- 30 minutes) postoperatively respiratory rate, oxygen saturation, mean arterial pressure, and heart rate.
Any reports of headache, dizziness, nausea, vomiting, pruritis, agitation, constipation, insomnia, bradycardia (Heart rate below 60 beats per minute), hypotension (MAP less than 30% of baseline), or urinary retention will be recorded throughout the study and will be treated appropriately as they occur, and the treatment medication will be stopped if determined to be a causative factor.
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4-hour intervals (+/- 30 minutes) for 24-hrs averaged
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Andre resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Total PCA Morphine
Tidsramme: Duration of operation
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Amount of morphine used during surgery
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Duration of operation
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Jason Felton, MD, TTUHSC department of Surgery
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. oktober 2013
Primær færdiggørelse (Faktiske)
11. januar 2018
Studieafslutning (Faktiske)
11. januar 2018
Datoer for studieregistrering
Først indsendt
11. februar 2014
Først indsendt, der opfyldte QC-kriterier
12. februar 2014
Først opslået (Skøn)
13. februar 2014
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. maj 2020
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
22. april 2020
Sidst verificeret
1. april 2020
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- L14-015
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
IPD-planbeskrivelse
No data will be shared
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