- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03700970
Comparing Local Anesthetics for TAP Block During Abdominally-based Free Flap for Breast Reconstruction
24. december 2021 opdateret af: Galen Perdikis, Vanderbilt University Medical Center
Double-Blinded Randomized Control Trial Comparing Liposomal Bupivacaine and Bupivacaine Hydrochloride in Transversus Abdominis Plane Blocks Prior To DIEP Flap for Breast Reconstruction
This study will compare the efficiency of transversus abominus plane (TAP) block using liposomal bupivacaine versus plain bupivacaine that is administered in the operating room under ultrasound guidance prior to the in patients undergoing abdominally-based free flap breast reconstruction at Vanderbilt University Medical Center.
Studieoversigt
Status
Afsluttet
Intervention / Behandling
Detaljeret beskrivelse
Transversus Abdominis Plane (TAP) blocks are commonly used as part of Enhanced Recovery After Surgery (ERAS) pathway.
This prospective, double-blinded, randomized control trial compares post-operative pain and narcotic consumption after deep inferior epigastric artery perforator (DIEP) breast reconstruction with liposomal bupivacaine (LB) compared to bupivacaine hydrochloride (BHCl).
Subjects undergoing DIEP flaps were randomly assigned LB or BHCl, performed using ultrasound-guided TAP block technique pre-procedurally.
Primary outcomes were postoperative narcotic analgesia required in oral morphine equivalents (OME) from postoperative day (POD) 0 to 7. Secondary outcomes included POD 1-7 pain Numeric Rating Scale (NRS), non-narcotic pain medication consumption, time to first narcotic use, return of bowel function, and length of stay (LOS).
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Fase 4
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Tennessee
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Nashville, Tennessee, Forenede Stater, 37212
- Vanderbilt University 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
18 år til 85 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Beskrivelse
Inclusion Criteria:
- age between 18-85 years
- males or females
- plastic surgery for abdominally-based free flap breast reconstruction.
Exclusion Criteria:
- those not candidates for TAP blocks due to allergies to the medications (e.g., bupivacaine)
- those with anatomic contra-indications to performing a TAP block
- those unwilling to participate in follow-up assessments
- vulnerable populations
- chronic pain or associated diagnosis
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
---|---|
Eksperimentel: TAP block with liposomal bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia.
Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest.
The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane.
20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
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20mL of Exparel® 1.3% mixed with 20mL of 0.25% bupivacaine, for a total of 40mL of local anesthestic mixture, 20mL to be injected on each side.
Andre navne:
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Aktiv komparator: TAP block with regular bupivacaine
Local analgesia (TAP blocks) will be administered under ultrasound guidance in the operating room after the patient is intubated and under general anesthesia.
Under sterile conditions and ultrasound guidance, the fascial plane between the internal oblique and transversus abdominis muscles (muscles of the abdominal wall) will be identified at the anterior axillary line, midway between the costal margin and iliac crest.
The epidural needle will be inserted through the skin to the appropriate fascial plane, and the local anesthetic will be injected in that plane.
20mL of 0.25% bupivacaine injected on each side.
|
20mL of 0.25% bupivacaine injected on each side.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Amount of Supplemental Postoperative Narcotic Analgesia in Oral Morphine Equivalents (OME)
Tidsramme: Postoperative day (POD) 1 to 7
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Amount of supplemental postoperative narcotic analgesia (both intravenous and oral) required by study groups in oral morphine equivalents
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Postoperative day (POD) 1 to 7
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Pain Measure
Tidsramme: Post operative day (POD) 1 to 7
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Pain as measured by numeric rating scale ranging from 0 (no pain) to 10 (worst pain ever).
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Post operative day (POD) 1 to 7
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Time to First Opiate Use
Tidsramme: 0-29.8 hours post operation
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Time from end of surgery to time of first opioid intake measured in hours
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0-29.8 hours post operation
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Time to Return of Bowel Function
Tidsramme: 1 to 4 days post operation
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Mean time in days at which patients had a return of bowel movement post op
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1 to 4 days post operation
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Length of Stay
Tidsramme: 1 to 4 days
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Length of hospital stay post operatively
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1 to 4 days
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Ambulation
Tidsramme: 1 day post op
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Time to first ambulate post op (in days)
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1 day post op
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Non-narcotic Pain Medication Intake: Acetaminophen
Tidsramme: Post op day 1 to 7
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The total use of the non-narcotic pain medication Acetaminophen was recorded during hospitalization
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Post op day 1 to 7
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Non Narcotic Pain Medication Intake: Cyclobenzaprine
Tidsramme: Post op day 1 to 7
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The total use of the non-narcotic pain medication Cyclobenzaprine was recorded during hospitalization
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Post op day 1 to 7
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Non Narcotic Pain Medication Intake: Gabapentin
Tidsramme: Post op day 1 to 7
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The total use of the non-narcotic pain medication gabapentin was recorded during hospitalization
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Post op day 1 to 7
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Non Narcotic Pain Medication Intake: Celebrex
Tidsramme: post op day 1 to 7
|
The total use of the non-narcotic pain medication celebrex was recorded during hospitalization
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post op day 1 to 7
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Non Narcotic Pain Medication Intake: Ondansetron
Tidsramme: Post op day 1 to 7
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The total use of the non-narcotic pain medication ondansetron was recorded during hospitalization
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Post op day 1 to 7
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Ledende efterforsker: Galen Perdikis, MD, Vanderbilt University Medical Center
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 (Faktiske)
13. juni 2019
Primær færdiggørelse (Faktiske)
15. marts 2021
Studieafslutning (Faktiske)
30. marts 2021
Datoer for studieregistrering
Først indsendt
2. oktober 2018
Først indsendt, der opfyldte QC-kriterier
6. oktober 2018
Først opslået (Faktiske)
9. oktober 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
24. januar 2022
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
24. december 2021
Sidst verificeret
1. december 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 180421
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