- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT03001453
Intraoperative Liposomal Bupivacaine vs. Bupivacaine for Total Hip Replacement Pain Management
Post-surgical Pain Care Pathways During Enhanced Recovery Surgery Using Exparel (Bupivacaine Liposome Injectable Suspension) Plus Bupivacaine With Epinephrine Versus Bupivacaine.
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Yksityiskohtainen kuvaus
All surgeries were performed by the same orthopaedic surgeon. Two groups, one receiving Exparel® (bupivacaine liposome injectable suspension) plus bupivacaine with epinephrine (LB group) and the other receiving bupivacaine with epinephrine (Control group), will be compared using post-operative pain scores, hospital length of stay, time to ambulation, falls, narcotic use, and narcotic-related adverse effects. Aside from hospital length of stay, all outcomes were recorded for up to 72 hours following surgery. An a priori power analysis was performed to calculate the total number of patients that needed to be enrolled to achieve a minimum 90% power, with the threshold of statistical significance set to 0.05. Based on a previous study reporting a mean oral opioid consumption of 57.04mg ± 25.6 at 24 hours post THR, a mean difference of 17.14mg was considered to be clinically significant. Thus, at least 26 patients were necessary in each group for an adequately powered assessment. The diagnosis for osteoarthritis was determined by patient history, physical examination, and imaging findings. Each patient received a thorough explanation of the protocol, and willing patients signed an informed consent form. All patients underwent a personal preoperative education program regarding pre, intra-, and post-procedural information including physical therapy, expectations, discharge goals, home therapy, and pain management. After written consent was collected, the form was sent to the hospital pharmacy for randomization. Envelopes were randomized, sealed, numbered, and given to the pharmacy staff, ultimately dispensing the envelopes to the nurse in the operating room in numerical order. The pharmacy documented the required information, selected medication, and drug accountability forms according to the contents of the envelopes.
A nurse delivered study drugs to the operating room in a sealed, non-descriptive envelope. During the standard anterior approach procedure, an anesthesiologist administered fentanyl or hydromorphone as needed for analgesia. The local anesthetics were administered after reduction of the implants. Patients in the LB group received 20cc liposomal bupivacaine, 40cc 0.25% bupivacaine with epinephrine, and 20cc of normal saline. Each patient in the control group received 60cc of 0.25% bupivacaine with epinephrine. Using a 20-gauge spinal needle, the local anesthetics were injected using a deep tissue administration technique. Structures innervated by the femoral nerve, superior gluteal nerve, or lateral femoral cutaneous nerve were considered suitable for injection. Throughout administration, frequent aspirations were performed to check for blood and minimize the risk of intravascular injection. The patients, surgical team, and floor staff was blinded to the local anesthetic drugs given.
During hospitalization, patients were observed, evaluated and treated according to postoperative protocols. Patients received opioids for pain management as needed, which was routinely documented by hospital staff. Opioids included fentanyl, hydromorphone, oxycodone, codeine, tramadol, morphine, and hydrocodone. All opioid dosages were converted into morphine equivalent dosages for analysis. Each patient began physical therapy within the first 24 hours postoperatively. Patients were discharged when they were able to begin self-care, their pain was controlled utilizing an oral regimen, and they were able to tolerate oral medication intake.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Illinois
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Hinsdale, Illinois, Yhdysvallat, 60521
- Adventist Hinsdale Hospital
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Westmont, Illinois, Yhdysvallat, 60559
- American Hip Institute
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Patients scheduled to undergo primary unilateral total hip replacement
- Patients diagnosed with hip osteoarthritis
- Patients failed to improve with conservative measures
- Patients willing and able to sign informed consent
Exclusion Criteria:
- Revision total hip replacement
- Bilateral total hip replacement
- Birmingham hip resurfacing
- Patients with hepatic/kidney disease
- Patients with a known allergy to bupivacaine or other local anesthetics
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kolminkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: Liposomal bupivacaine
Periarticular infiltration cocktail of 20cc of liposomal bupivacaine with 20cc of normal saline and 40cc of 0.25% bupivacaine with epinephrine
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266mg liposomal bupivacaine
Muut nimet:
0.25% bupivacaine with epinephrine
Muut nimet:
Normaali suolaliuos
Muut nimet:
|
|
Active Comparator: Bupivacaine with epinephrine
Periarticular infiltration cocktail of 60cc of 0.25% bupivacaine with epinephrine
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0.25% bupivacaine with epinephrine
Muut nimet:
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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Patient Morphine Equivalent Consumption
Aikaikkuna: 72 hours postoperation, divided into six 12-hour periods
|
All opioid doses were administered to the patient at 12-hour intervals post-surgery.
Doses were recorded till either of the following criteria was met, the patient was discharged or the 72-hour post-surgery timeframe ended.
The doses were then collected and converted to OMEs, in milligrams.
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72 hours postoperation, divided into six 12-hour periods
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Change in Patient-reported Visual Analog Scale (VAS) Pain Intensity Score
Aikaikkuna: 72 hours post-operation, divided into six 12-hour periods
|
Patient-reported VAS pain intensity score (0 = no pain, 10 = worst pain possible) will be collected.
Mean VAS scores for the 72-hour period were calculated using the cohort's reported average pain scores at each 12-hour interval.
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72 hours post-operation, divided into six 12-hour periods
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Time to Ambulation More Than 20 Feet (in Hours)
Aikaikkuna: from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
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The length of time (in hours) until the patient first ambulates more than 20 feet from the time of surgery will be recorded.
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from time of surgery until patient first ambulates more than 20 feet or 72 hours post-surgery or patient discharge, whichever comes first
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Length of Stay (LOS, in Days)
Aikaikkuna: From time of surgery until patient is discharged, an average of 1.5 days.
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From time of surgery until patient is discharged, an average of 1.5 days.
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|
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Number of Patients That Experienced a Fall
Aikaikkuna: 72 hours postoperation
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72 hours postoperation
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Benjamin G Domb, MD, American Hip Institute
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Postoperatiiviset komplikaatiot
- Kipu
- Neurologiset ilmenemismuodot
- Kipu, Leikkauksen jälkeinen
- Huumeiden fysiologiset vaikutukset
- Adrenergiset aineet
- Neurotransmitterit
- Farmakologisen vaikutuksen molekyylimekanismit
- Keskushermostoa lamaavat aineet
- Autonomiset agentit
- Ääreishermoston aineet
- Aistijärjestelmän agentit
- Anestesia-aineet
- Adrenergiset alfa-agonistit
- Adrenergiset agonistit
- Anestesialääkkeet, paikalliset
- Keuhkoputkia laajentavat aineet
- Astmaattiset aineet
- Hengityselinten aineet
- Adrenergiset beeta-agonistit
- Sympatomimeetit
- Vasokonstriktoriaineet
- Mydriatics
- Bupivakaiini
- Epinefriini
Muut tutkimustunnusnumerot
- AHI-001
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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