- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT03376048
Local Wound Infiltration Plus TAP Block Versus Local Wound Infiltration Only
Comparison of Analgesic Efficacy of Local Wound Infiltration Plus Transversus Abdominis Plane Block and Local Wound Infiltration Only After Laparoscopic Colorectal Resection: a Randomized, Double-blind, Non-inferiority Trial
The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
In colorectal surgery, laparoscopy and enhanced recovery after surgery (ERAS) programs have significantly improved the short-term outcomes (1). Although the laparoscopic approach reduces pain and recovery time, post-operative pain, nausea and vomiting still represent an issue. In order to reduce opioid related side effects, such as postoperative nausea and vomiting (PONV), constipation and prolonged post-operative ileus, non-opioid based multimodal analgesia have been recently introduced. Although epidural analgesia has gained good success, it does not seem to offer any additional clinical benefits to patients undergoing laparoscopic colorectal surgery compared to alternative analgesic technique within an ERAS program. Both local wound infiltration (WI) and TAP block are common techniques in multimodal postoperative pain treatment, and their association allows to achieve pain control despite a reduced use of opioid analgesics. Furthermore, in a recent single-blind prospective study TAP block resulted superior to wound infiltration alone. The TAP block is typically performed either with ultrasound guidance (TAP-US) or laparoscopic visualization (TAP-LAP): comparison between these two technics showed no differences in pain control and use of opioid analgesics.
The aim of this study is to compare WI + TAP-LAP versus WI alone. The investigators hypothesize that WI is non-inferior to WI + TAP-block with respect to postoperative pain.
Undersøgelsestype
Tilmelding (Faktiske)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
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Verona, Italien, 37134
- University of Verona Hospital Trust and Colorectal Cancer Center
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Daegu, Korea, Republikken, 41404
- Kyungpook National University Chilgok Hospital
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Aged 18-80 years, either sex
- Patients scheduled to undergo elective laparoscopic colorectal surgery under general anesthesia
- Willingness and ability to sign an informed consent document
Exclusion Criteria:
- Allergies to anesthetic or analgesic medications
- Contraindication to the use of locoregional anesthesia
- Chronic opioid use
- Coagulopathy, Impaired kidney function, uncontrolled diabetes, psychiatric disorders, severe cardiovascular impairment or chronic obstructive lung disease
- Necessity of major resection other than colorectal, palliative surgery
- BMI above 35 kg/m2
- American Society of Anesthesiologists (ASA) physical status above 3
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Tredobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: Wound infiltration plus TAP
Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon
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Andre navne:
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Aktiv komparator: Wound infiltration
Wound infiltration placed by surgeon
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Wound infiltration of ropivacaine will be performed by the surgeon before skin incision.
Andre navne:
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Pain numerical rating scale (NRS)
Tidsramme: within the first 6 hours after surgery
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within the first 6 hours after surgery
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Tid til første orale væskeindtag
Tidsramme: 8 uger efter operationen
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Tid til første orale væskeindtag efter operationen
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8 uger efter operationen
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Tid til den første orale bløde diæt
Tidsramme: 8 uger efter operationen
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Tid til den første orale bløde diæt efter operationen
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8 uger efter operationen
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Længde af hospitalsophold
Tidsramme: 8 uger efter operationen
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Længde af hospitalsophold efter indlæggelse
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8 uger efter operationen
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Pain NRS
Tidsramme: 12, 24, 36, 48, 72 hour after surgery
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12, 24, 36, 48, 72 hour after surgery
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Rescue opioid analgesic requirement
Tidsramme: postoperative day 0, 1, 2, 3
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Overall postoperative rescue of opioid analgesic requirement described by using the Defined Daily Dose
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postoperative day 0, 1, 2, 3
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Postoperative nausea and vomiting scale
Tidsramme: 12, 24, 36, 48, 72 hour after surgery
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PONV scores (assessed using a 0 - 2 categorical scale; no nausea/ nausea/ vomiting)
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12, 24, 36, 48, 72 hour after surgery
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Occurrence of prolonged post-operative ileus
Tidsramme: 8 weeks after surgery
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Occurrence of prolonged post-operative ileus (assessed using a 0 - 1 categorical scale; no ileus/ileus)
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8 weeks after surgery
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Samarbejdspartnere og efterforskere
Efterforskere
- Ledende efterforsker: Soo Yeun Park, MD, Kyungpook National University Chilgok Hospital
- Ledende efterforsker: Corrado Pedrazzani, MD, University of Verona Hospital Trust and Colorectal Cancer Center
Publikationer og nyttige links
Generelle publikationer
- Pedrazzani C, Park SY, Conti C, Turri G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of pre-emptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: results from a randomized, multicenter, single-blind, non-inferiority trial. Surg Endosc. 2021 Jul;35(7):3329-3338. doi: 10.1007/s00464-020-07771-6. Epub 2020 Jul 6.
- Pedrazzani C, Park SY, Scotton G, Park JS, Kim HJ, Polati E, Guglielmi A, Choi GS. Analgesic efficacy of preemptive local wound infiltration plus laparoscopic-assisted transversus abdominis plane block versus wound infiltration in patients undergoing laparoscopic colorectal resection: study protocol for a randomized, multicenter, single-blind, noninferiority trial. Trials. 2019 Jul 2;20(1):391. doi: 10.1186/s13063-019-3509-y.
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
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
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- KNUHC01
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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