Intraoperative Intravenous Lidocaine for Pain After Laparoscopic Appendectomy (LIDO-APP)
28 juni 2026 uppdaterad av: Joseph Alejandro Veraza Almeida, Hospital Universitario de Caracas
Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial
This randomized, double-blind, placebo-controlled clinical trial evaluated whether intraoperative intravenous lidocaine infusion improves postoperative analgesia and recovery in patients undergoing laparoscopic appendectomy.
The primary objective was to assess postoperative pain intensity and opioid consumption.
Secondary outcomes included postoperative nausea and vomiting, time to bowel function recovery, length of hospital stay, plasma lidocaine concentrations, and adverse events.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Postoperative pain following laparoscopic appendectomy remains an important clinical concern despite advances in multimodal analgesia. Intravenous lidocaine has been proposed as an effective adjunct because of its analgesic, anti-inflammatory, and antihyperalgesic properties, but evidence in laparoscopic appendectomy remains limited.
This prospective, randomized, double-blind, placebo-controlled trial compared continuous intraoperative intravenous lidocaine infusion with placebo in patients undergoing laparoscopic appendectomy under standardized general anesthesia. Patients were randomly allocated to receive either lidocaine or placebo according to the study protocol.
The primary outcome was postoperative pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included opioid requirements, postoperative nausea and vomiting, return of bowel function, length of hospital stay, incidence of adverse events, and perioperative plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points.
The study aimed to determine the clinical efficacy and safety of intravenous lidocaine infusion as part of multimodal perioperative analgesia for laparoscopic appendectomy and to correlate analgesic effects with measured plasma lidocaine concentrations.
Studietyp
Interventionell
Inskrivning (Faktisk)
225
Fas
- Fas 4
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
Miranda
-
Caracas, Miranda, Venezuela, 1040
- Hospital Universitario de Caracas
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Ja
Beskrivning
Inclusion Criteria:
- Adults aged 18 to 45 years.
- ASA physical status I or II.
- Scheduled for laparoscopic appendectomy under general anesthesia.
- Able to provide written informed consent.
Exclusion Criteria:
- History of cardiac conduction disorders or documented arrhythmias.
- Hepatic insufficiency.
- Renal insufficiency.
- Chronic or long-term opioid therapy.
- Known or suspected hypersensitivity to amide-type local anesthetics.
- Hemodynamic instability at the time of admission to the operating room.
- Body mass index greater than 35 kg/m².
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Fyrdubbla
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Intravenous lidocaine group
Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol.
|
Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.
|
|
Placebo-jämförare: Placebo group
Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions.
|
Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Postoperative pain intensity
Tidsram: At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
|
Postoperative pain intensity assessed using the Visual Analogue Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain.
Lower scores indicate better analgesic efficacy.
|
At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Total opioid comsumption
Tidsram: From surgery completion through 24 hours after surgery.
|
Total postoperative opioid requirement during the first 24 hours after surgery.
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From surgery completion through 24 hours after surgery.
|
|
Post operative nausea and vomiting
Tidsram: From surgery completion through 24 hours after surgery.
|
Incidence of postoperative nausea and vomiting requiring treatment
|
From surgery completion through 24 hours after surgery.
|
|
Time to return of bowel function
Tidsram: From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
|
Time from surgery completion to first flatus or bowel movement.
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From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
|
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Lengh of hospital stay
Tidsram: From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
|
Time from surgery completion until hospital discharge.
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From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
|
|
Plasma lidocaine concentration
Tidsram: From baseline through 1 hour after admission to the post-anesthesia care unit (PACU), with plasma lidocaine concentrations assessed at baseline, 30 minutes after study drug infusion initiation, 90 minutes after study drug infusion initiation, and 1 hour
|
Plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points to evaluate systemic exposure and pharmacokinetic profile.
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From baseline through 1 hour after admission to the post-anesthesia care unit (PACU), with plasma lidocaine concentrations assessed at baseline, 30 minutes after study drug infusion initiation, 90 minutes after study drug infusion initiation, and 1 hour
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: JOSEPH A VERAZA, MD, sociedad medica joseph veraza
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
1 februari 2024
Primärt slutförande (Faktisk)
1 januari 2025
Avslutad studie (Faktisk)
1 januari 2025
Studieregistreringsdatum
Först inskickad
14 juni 2026
Först inskickad som uppfyllde QC-kriterierna
28 juni 2026
Första postat (Faktisk)
1 juli 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
1 juli 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
28 juni 2026
Senast verifierad
1 juni 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- HUC-LIDO-APP-2024-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
IPD-planbeskrivning
Individual participant data (IPD) will not be publicly shared.
De-identified data may be made available by the corresponding author upon reasonable request and subject to institutional and ethical approval.
Läkemedels- och apparatinformation, studiedokument
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Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
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