- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT02875015
Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement
5. juni 2018 opdateret af: charbel salamon, Atlantic Health System
Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement: a Randomized Control Trial
Postoperative pain, the quality of their recovery and the opioid consumption following a midurethral sling placement are being compared between 2 groups.
One group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution.
The other group will have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
This is a prospective, comparative, randomized study.
Women with pure stress urinary incontinence or mixed urinary incontinence with a predominant stress component who had chosen to proceed with a midurethral sling will be randomized to two groups.
The study group will have the hydro-dissection performed with a diluted liposomal bupivacaine solution.
The comparison group would have the hydro-dissection performed with a diluted bupivacaine HCL and Lidocaine solution.
The postoperative pain will be compared between groups using a visual analog scale.
The quality of recovery will be compared between the groups using the quality of recovery short form.
Postoperative opioid consumption will be compared between the two groups.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
57
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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New Jersey
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Morristown, New Jersey, Forenede Stater, 07960
- Morrristown Medical Center
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Summit, New Jersey, Forenede Stater, 07901
- Overlool Medical 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
19 år og ældre (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
Inclusion Criteria:
- ASA physical status I-III
- Age >18 years
- Not Pregnant
- Able to give informed consent
- Electively chose surgical management of SUI with a suburethral sling
Exclusion Criteria:
- Pregnant or nursing
- Allergy to amide anesthetics
- History of drug or alcohol abuse
- Severe cardiovascular, hepatic, renal disease or neurological impairment,
- Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
- Patients taking monoamineoxidase inhibitors (MAOI) or antidepressants of the triptyline or imipramine types
- Contraindication to: Acetaminophen, Non-steroidal anti-inflammatory drugs (NSAID), Hydrocodone, Oxycodone, Hydromorphone AND Morphine,
- Administration of an investigational drug within 30 days before this study
- Chronic pain syndromes
- Daily NSAID or opioid use
- Patients undergoing concomitant procedures
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Forebyggelse
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: Liposomal Bupivacaine
20mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
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20 mL of Liposomal Bupivacaine (EXPAREL) will be diluted in 80 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars
Andre navne:
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Andre navne:
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Aktiv komparator: Bupivacaine Hydrochloride and Lidocaine
Bupivacaine Hydrochloride (HCL) and Lidocaine.
Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
|
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Andre navne:
Bupivacaine Hydrochloride (HCL) and Lidocaine.
Fifty mL of 0.05% Marcaine and 30 mL of Lidocaine will be diluted in 100 mL of injectable saline used for hydro-dissection of the vesicovaginal space and along the track of the sling trocars during the placement of a suburethral sling.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Postoperative Day 1 Pain
Tidsramme: Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Average pain rating experienced on postoperative day one using the visual analog scale (VAS) on scale of 0 to 10 cm.
This will be recorded by the patient prior to going to bed.
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Patient will record her average pain on postop day 1. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Second Stage PACU Postoperative Pain
Tidsramme: The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon admission to second stage PACU.
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The PACU nurse will record the patient's pain level upon admission to second stage PACU. These results will be examined and compared at the completion of the study.
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Postoperative Pain Upon Discharge
Tidsramme: The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced upon discharge from the hospital.
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The PACU nurse will record the patient's pain level upon discharge to home. These results will be examined and compared at the completion of the study.
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Postoperative Pain Four Hours After Discharge
Tidsramme: Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced.
This will be recorded 4 hours after being discharged from the hospital.
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Record the average pain 4 hours after discharge to home. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Night of Surgery Postoperative Pain
Tidsramme: Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on the night of surgery.
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Pt will record her average pain on the night of surgery. She will return this result at her postop visit which is approximately 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Postoperative Days 2 through 7 Pain
Tidsramme: Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Visual analog scale (VAS) on scale of 0 to 10 cm will be used to evaluate the pain score experienced that day and recorded prior to going to bed on postop days 2-7.
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Pt will record her average pain from postop days 2-7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Preoperative Quality of Recovery
Tidsramme: The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.
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Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.
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The patient will complete the questionnaire prior to surgery. This will be collected prior to surgery. These results will be examined and compared at the completion of the study.
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Postoperative Days 1, 7 and 14 Quality of Recovery
Tidsramme: The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14.
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The patient will complete the questionnaire on postop days 1, 7 & 14. She will return these results at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Postoperative Narcotic Consumption
Tidsramme: The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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The total amount of narcotic taken the night of surgery and each day thereafter through postoperative day seven will be recorded each night prior to going to bed.
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The patient will record narcotic consumption each day from the day of surgery to postop day 7. She will return this result at her postop visit 4-6 weeks after her surgery. These results will be examined and compared at the completion of the study.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Charbel Salamon, MD, Atlantic Health System
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. april 2016
Primær færdiggørelse (Faktiske)
1. maj 2018
Studieafslutning (Faktiske)
1. maj 2018
Datoer for studieregistrering
Først indsendt
27. juni 2016
Først indsendt, der opfyldte QC-kriterier
17. august 2016
Først opslået (Skøn)
23. august 2016
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
6. juni 2018
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
5. juni 2018
Sidst verificeret
1. juni 2018
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Postoperative komplikationer
- Smerte
- Neurologiske manifestationer
- Smerter, postoperativ
- Lægemidlers fysiologiske virkninger
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Depressive midler til centralnervesystemet
- Agenter fra det perifere nervesystem
- Sensoriske systemagenter
- Bedøvelsesmidler
- Membrantransportmodulatorer
- Bedøvelsesmidler, lokale
- Spændingsstyret natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
- Bupivacain
Andre undersøgelses-id-numre
- 883788-1
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
INGEN
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