Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement
5. juni 2018 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
57
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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New Jersey
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Morristown, New Jersey, Forente stater, 07960
- Morrristown Medical Center
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Summit, New Jersey, Forente stater, 07901
- Overlool Medical Center
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
19 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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 navn:
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Andre navn:
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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.
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A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Andre navn:
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 navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
Tidsramme |
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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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Charbel Salamon, MD, Atlantic Health System
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. april 2016
Primær fullføring (Faktiske)
1. mai 2018
Studiet fullført (Faktiske)
1. mai 2018
Datoer for studieregistrering
Først innsendt
27. juni 2016
Først innsendt som oppfylte QC-kriteriene
17. august 2016
Først lagt ut (Anslag)
23. august 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
6. juni 2018
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. juni 2018
Sist bekreftet
1. juni 2018
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Postoperative komplikasjoner
- Smerte
- Nevrologiske manifestasjoner
- Smerter, postoperativt
- Fysiologiske effekter av legemidler
- Molekylære mekanismer for farmakologisk virkning
- Anti-arytmimidler
- Sentralnervesystemdepressiva
- Agenter fra det perifere nervesystemet
- Sensoriske systemagenter
- Bedøvelsesmidler
- Membrantransportmodulatorer
- Anestesimidler, lokal
- Spenningskontrollerte natriumkanalblokkere
- Natriumkanalblokkere
- Lidokain
- Bupivakain
Andre studie-ID-numre
- 883788-1
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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