Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy (LAVA)
Long-acting Local Vaginal Cuff Anesthesia Following Hysterectomy: LAVA Trial
The purpose of this study is to compare recovery unit and post operation day (POD) 1 pain score in women following elective robotic assisted TLH (RA-TLH) for benign indication with and without local vaginal cuff injection of short acting bupivacaine and long acting Exparel, to evaluate postoperative pain management and control by assessing the amount and frequency of NSAIDS and opioids taken and to assess bleeding, vaginal discharge and or vaginal dehiscence at the postoperative follow up visit.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Studiekontakt
- Navn: Asha B Bhalwal, MD
- Telefonnummer: (713) 566-4605
- E-mail: Asha.B.Bhalwal@uth.tmc.edu
Undersøgelse Kontakt Backup
- Navn: Aya Sasson Mohr
- Telefonnummer: (713) 500-6412
- E-mail: Aya.MohrSasson@uth.tmc.edu
Studiesteder
-
-
Texas
-
Houston, Texas, Forenede Stater, 77030
- The University of Texas Health Science Center, Houston
-
Kontakt:
- Asha B Bhalwal, MD
- Telefonnummer: (713) 566-4605
- E-mail: Asha.B.Bhalwal@uth.tmc.edu
-
Kontakt:
- Aya Sasson Mohr
- Telefonnummer: (713) 500-6412
- E-mail: Aya.MohrSasson@uth.tmc.edu
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- at least 66.5kg weight
- elective Robotic assisted (RA) Total Laparoscopic Hysterectomy (TLH) for benign indications at Memorial Hermann Hospital Texas Medical Center, Memorial Hermann Hospital Cypress and Memorial Hermann Hospital Greater Heights.
Exclusion Criteria:
- Combined operation or alternative approach
- inpatient overnight admission
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Placebo komparator: Styring
|
In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will get will get vaginal cuff infiltration with 20 cc of injectable NS at the end of the procedure. |
|
Eksperimentel: Combined Bupivacaine and Exparel
|
In addition to the Laparoscopic Transversus Abdominis Plane (TAP) Block, participants will receive 20 cc of a mixture of 40 cc of short term 0.25% bupivacaine hydrochloride and long term 20 mL of Exparel® (266 mg/20 mL) mixed with 100cc of normal saline (total amount 160 cc) to the vaginal cuff using William's cystoscopy needle. The mixture will be infiltrated evenly at the uterosacral ligament with care (10 cc on each uterosacral ligament) taken to distribute the injection across the full length of the cuff at the end of the procedure. |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in pain as assessed by the visual analog scale (VAS)
Tidsramme: 4-6 hours post operation, postoperative day 1, postoperative day 3
|
Pain will be scored from 1-10 , higher number indicating more pain |
4-6 hours post operation, postoperative day 1, postoperative day 3
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in level of pain control achieved as assessed by the amount of nonsteroidal anti-inflammatory drugs (NSAIDs) needed
Tidsramme: 2-week and 6- week follow up
|
2-week and 6- week follow up
|
|
|
Change in level of pain control achieved as assessed by the frequency of NSAIDS needed
Tidsramme: 2-week and 6- week follow up
|
2-week and 6- week follow up
|
|
|
Change in level of pain control achieved as assessed by the amount of opioids needed
Tidsramme: 2-week and 6- week follow up
|
2-week and 6- week follow up
|
|
|
Change in level of pain control achieved as assessed by the frequency of opioids needed
Tidsramme: 2-week and 6- week follow up
|
2-week and 6- week follow up
|
|
|
Change in level of bleeding as assessed by the volume of blood loss reported by the surgeon
Tidsramme: 2-week and 6- week follow up
|
2-week and 6- week follow up
|
|
|
Change in presence of vaginal dehiscence
Tidsramme: 2-week and 6- week follow up
|
This will be categorically reported as a yes or no answer |
2-week and 6- week follow up
|
Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Asha B Bhalwal, MD, The University of Texas Health Science Center, Houston
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- HSC-MS-26-0008
Plan for individuelle deltagerdata (IPD)
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Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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