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Liposomal Bupivacaine vs. Bupivacaine Hydrochloride and Lidocaine During Suburethral Sling Placement

5. Juni 2018 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

57

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Vereinigte Staaten
    • New Jersey
      • Morristown, New Jersey, Vereinigte Staaten, 07960
        • Morrristown Medical Center
      • Summit, New Jersey, Vereinigte Staaten, 07901
        • Overlool Medical Center

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

19 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Ja

Studienberechtigte Geschlechter

Weiblich

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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.
Arzneimittel: Liposomal Bupivacaine
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
Andere Namen:
  • EXPAREL
Verfahren: Suburethral Sling
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Andere Namen:
  • Midurethral Sling
Aktiver 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.
Verfahren: Suburethral Sling
A retropubic, transobturator or mini-sling will be placed in the usual fashion followed by diagnostic cystoscopy.
Andere Namen:
  • Midurethral Sling
Arzneimittel: 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.
Andere Namen:
  • Marcaine and Lidocaine

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Postoperative Day 1 Pain
Zeitfenster: 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.
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.
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.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Second Stage PACU Postoperative Pain
Zeitfenster: 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.
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.
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.
Postoperative Pain Upon Discharge
Zeitfenster: 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.
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.
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.
Postoperative Pain Four Hours After Discharge
Zeitfenster: 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.
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.
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.
Night of Surgery Postoperative Pain
Zeitfenster: 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.
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.
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.
Postoperative Days 2 through 7 Pain
Zeitfenster: 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.
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.
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.
Preoperative Quality of Recovery
Zeitfenster: 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.
Baseline Quality of Life and Recovery as measured by the ambulatory QoR15 preoperatively on the day of surgery.
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.
Postoperative Days 1, 7 and 14 Quality of Recovery
Zeitfenster: 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.
Quality of Life and Recovery as measured by the ambulatory QoR15 on postoperative days 1, 7 and 14.
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.
Postoperative Narcotic Consumption
Zeitfenster: 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.
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.
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.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Atlantic Health System

Ermittler

  • Hauptermittler: Charbel Salamon, MD, Atlantic Health System

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. April 2016

Primärer Abschluss (Tatsächlich)

1. Mai 2018

Studienabschluss (Tatsächlich)

1. Mai 2018

Studienanmeldedaten

Zuerst eingereicht

27. Juni 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

17. August 2016

Zuerst gepostet (Schätzen)

23. August 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. Juni 2018

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

5. Juni 2018

Zuletzt verifiziert

1. Juni 2018

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 883788-1

Plan für individuelle Teilnehmerdaten (IPD)

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NEIN

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