Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair (LIDO-TAPP)
1 september 2026 bijgewerkt door: Hakan Emirkadı
The Effect of Intravenous Lidocaine on Postoperative Fatigue Syndrome in Patients Undergoing Elective Laparoscopic TAPP Inguinal Hernia Repair
This prospective randomized placebo-controlled trial aims to evaluate the effect of perioperative intravenous lidocaine on postoperative fatigue in patients undergoing elective laparoscopic TAPP inguinal hernia repair.
Participants will be randomly assigned to receive either intravenous lidocaine or an equal-volume 0.9% sodium chloride placebo.
The primary outcome is postoperative physical fatigue assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20).
Secondary outcomes include postoperative pain, cumulative tramadol consumption, postoperative nausea and vomiting, and the requirement for additional analgesia.
Studie Overzicht
Toestand
Nog niet aan het werven
Interventie / Behandeling
Gedetailleerde beschrijving
Postoperative fatigue may negatively affect recovery after surgery. Intravenous lidocaine has analgesic, anti-inflammatory, and opioid-sparing properties that may influence postoperative recovery.
This prospective randomized placebo-controlled trial will include adult patients undergoing elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair under general anesthesia. Eligible participants will be randomly allocated to receive either perioperative intravenous lidocaine or an equal-volume 0.9% sodium chloride placebo according to the same administration schedule. Participants, anesthesia care providers, and postoperative outcome assessors will be blinded to treatment allocation.
The primary outcome is postoperative physical fatigue assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20), with a preoperative baseline assessment and postoperative assessments on days 1, 3, 5, and 7. Secondary outcomes include postoperative pain intensity, cumulative tramadol consumption during the first 24 postoperative hours, postoperative nausea and vomiting, and the requirement for additional analgesia during the first 24 postoperative hours.
Studietype
Ingrijpend
Inschrijving (Geschat)
80
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studiecontact
- Naam: Hakan Emirkadı, MD
- Telefoonnummer: +905322609367
- E-mail: hemirkadi@gmail.com
Studie Locaties
-
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Istanbul
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Istanbul, Istanbul, Turkije (Türkiye), 34668
- University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital
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Contact:
- Hakan Emirkadı, MD
- Telefoonnummer: +905322609367
- E-mail: hemirkadi@gmail.com
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Nee
Beschrijving
Inclusion Criteria:
- Age 18 to 65 years
- Scheduled for elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair
- American Society of Anesthesiologists (ASA) physical status I or II
- Able to understand and complete the Multidimensional Fatigue Inventory-20 (MFI-20)
- Written informed consent provided
Exclusion Criteria:
- Known allergy or hypersensitivity to lidocaine or other amide-type local anesthetics
- Clinically significant hepatic or renal dysfunction
- Clinically significant cardiac rhythm or conduction disorder
- Chronic opioid use
- Regular use of antiarrhythmic medication
- Pregnancy or breastfeeding
- Planned use of an additional local anesthetic technique during the study intervention
- Inability to complete the study assessments
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ondersteunende zorg
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Verdrievoudigen
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Lidocaine Group
Participants in this group will receive intravenous lidocaine based on ideal body weight.
A loading dose of 1.5 mg/kg will be administered intravenously over 10 minutes before surgery, followed by a continuous infusion of 1.5 mg/kg/hour until the end of surgery.
The infusion will be discontinued if signs suggestive of local anesthetic systemic toxicity or clinically significant unexplained hemodynamic or cardiac conduction abnormalities occur.
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Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair.
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Placebo-vergelijker: Control Group
Participants in this group will receive an equal-volume 0.9% sodium chloride placebo administered according to the same timing and infusion protocol as the lidocaine group.
Standard perioperative care will otherwise be identical between groups.
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0.9% sodium chloride will be administered intravenously as placebo in an equal volume and according to the same timing and infusion protocol as the lidocaine intervention.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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MFI-20 Physical Fatigue Subscale Score
Tijdsspanne: Preoperative baseline and postoperative days 1, 3, 5, and 7
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Postoperative physical fatigue will be assessed using the Physical Fatigue subscale of the Multidimensional Fatigue Inventory-20 (MFI-20).
The Physical Fatigue subscale consists of four items and ranges from 4 to 20 points, with higher scores indicating greater physical fatigue.
A preoperative assessment will be obtained as the baseline value.
Postoperative assessments will be performed on postoperative days 1, 3, 5, and 7.
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Preoperative baseline and postoperative days 1, 3, 5, and 7
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Postoperative Pain Intensity (11-point Numeric Rating Scale)
Tijdsspanne: 2, 4, 6, 12, and 24 hours after surgery and postoperative days 3, 5, and 7
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Postoperative pain intensity will be assessed using an 11-point Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain), with higher scores indicating greater pain intensity.
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2, 4, 6, 12, and 24 hours after surgery and postoperative days 3, 5, and 7
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Postoperative Nausea and Vomiting Within 24 Hours
Tijdsspanne: First 24 hours after surgery
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Postoperative nausea and vomiting (PONV) will be assessed during the first 24 hours after surgery.
The occurrence of nausea and vomiting will be recorded separately, and the occurrence of either nausea or vomiting will be considered PONV.
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First 24 hours after surgery
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Cumulative Tramadol Consumption During the First 24 Postoperative Hours
Tijdsspanne: First 24 hours after surgery
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Total tramadol consumption delivered through patient-controlled analgesia (PCA) during the first 24 hours after surgery will be recorded in milligrams.
Higher values indicate greater postoperative opioid requirement.
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First 24 hours after surgery
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Requirement for Additional Analgesia During the First 24 Postoperative Hours
Tijdsspanne: First 24 hours after surgery
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The requirement for additional analgesia with intravenous paracetamol during the first 24 hours after surgery will be recorded.
The number and proportion of participants requiring at least one dose of additional analgesia will be compared between groups.
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First 24 hours after surgery
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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Geschat)
2 september 2026
Primaire voltooiing (Geschat)
31 december 2026
Studie voltooiing (Geschat)
31 januari 2027
Studieregistratiedata
Eerst ingediend
21 mei 2026
Eerst ingediend dat voldeed aan de QC-criteria
21 mei 2026
Eerst geplaatst (Werkelijk)
29 mei 2026
Updates van studierecords
Laatste update geplaatst (Werkelijk)
4 september 2026
Laatste update ingediend die voldeed aan QC-criteria
1 september 2026
Laatst geverifieerd
1 september 2026
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 25-42
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
NEE
Beschrijving IPD-plan
No individual participant data will be shared because the study involves sensitive clinical data and no public data-sharing plan has been established.
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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