- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
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Verona, Italien, 37134
- University of Verona Hospital Trust and Colorectal Cancer Center
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Daegu, Korea, Republiken av, 41404
- Kyungpook National University Chilgok Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Trippel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Wound infiltration plus TAP
Wound infiltration placed by surgeon + TAP-LAP placed laparoscopically guided by surgeon
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Andra namn:
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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.
Andra namn:
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Pain numerical rating scale (NRS)
Tidsram: within the first 6 hours after surgery
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within the first 6 hours after surgery
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Dags för första oralt vätskeintag
Tidsram: 8 veckor efter operationen
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Dags för första munvätskeintag efter operationen
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8 veckor efter operationen
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Dags för den första orala mjukdieten
Tidsram: 8 veckor efter operationen
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Dags för den första orala mjukdieten efter operationen
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8 veckor efter operationen
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Längden på sjukhusvistelsen
Tidsram: 8 veckor efter operationen
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Längd på sjukhusvistelse efter inläggning
|
8 veckor efter operationen
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Pain NRS
Tidsram: 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
Tidsram: postoperative day 0, 1, 2, 3
|
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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Utredare
- Huvudutredare: Soo Yeun Park, MD, Kyungpook National University Chilgok Hospital
- Huvudutredare: Corrado Pedrazzani, MD, University of Verona Hospital Trust and Colorectal Cancer Center
Publikationer och användbara länkar
Allmänna 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.
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- KNUHC01
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