Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair (LIDO-TAPP)
The Effect of Intravenous Lidocaine on Postoperative Fatigue Syndrome in Patients Undergoing Elective Laparoscopic TAPP Inguinal Hernia Repair
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Postoperative fatigue syndrome is a common problem after surgery and may negatively affect recovery quality, mobilization, and patient satisfaction. Intravenous lidocaine has anti-inflammatory, antihyperalgesic, and opioid-sparing properties that may improve postoperative recovery outcomes.
This prospective randomized controlled trial will include adult patients undergoing elective laparoscopic transabdominal preperitoneal (TAPP) inguinal hernia repair under general anesthesia. Eligible participants will be randomly allocated into two groups. The lidocaine group will receive perioperative intravenous lidocaine infusion according to the study protocol, while the control group will receive standard perioperative care without lidocaine infusion.
The primary outcome of the study is postoperative fatigue syndrome. Secondary outcomes include postoperative pain scores, opioid consumption, postoperative nausea and vomiting, time to mobilization, and duration of hospital stay.
The study is designed as an investigator-initiated academic clinical trial conducted at a tertiary training and research hospital in Türkiye.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Hakan Emirkadı, MD
- Telefonnummer: +905322609367
- E-mail: hemirkadi@gmail.com
Studiesteder
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Istanbul
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Istanbul, Istanbul, Tyrkiet (Türkiye), 34668
- University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital
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Kontakt:
- Hakan Emirkadı, MD
- Telefonnummer: +905322609367
- E-mail: hemirkadi@gmail.com
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-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion Criteria:
Adult patients aged 18 years and older Patients scheduled for elective laparoscopic TAPP inguinal hernia repair under general anesthesia ASA physical status I-II Patients who provide written informed consent -
Exclusion Criteria:
Moderate to severe hepatic dysfunction Low cardiac output or severe heart failure Severe cardiac conduction abnormalities or clinically significant arrhythmias Planned concomitant use of high-dose local anesthetics, including infiltration or regional block Advanced age or frailty Pregnancy or breastfeeding Known allergy or contraindication to lidocaine Refusal to participate in the study
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Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: Lidocaine Group
Participants in this group will receive perioperative intravenous lidocaine infusion according to ideal body weight.
A loading dose of 1.5 mg/kg lidocaine diluted in 50 or 100 mL normal saline will be administered over 10 minutes before surgery, followed by an infusion of 1.5 mg/kg/hour during surgery.
If the operation exceeds 2 hours, the infusion will be discontinued.
The duration of surgery will be recorded.
Lidocaine infusion will be stopped immediately if signs suggestive of local anesthetic systemic toxicity or unexplained hemodynamic instability occur during surgery.
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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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Ingen indgriben: Control Group
Participants in this group will receive standard perioperative care without intravenous lidocaine infusion during elective laparoscopic TAPP inguinal hernia repair.
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Fatigue Syndrome Score
Tidsramme: Postoperative days 1, 3, 5
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Assessment of postoperative fatigue syndrome and recovery quality using postoperative follow-up evaluations conducted on postoperative days 1, 3 and 5 after elective laparoscopic TAPP inguinal hernia repair.
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Postoperative days 1, 3, 5
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Pain Score
Tidsramme: Postoperative days 1, 3, and 5
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Assessment of postoperative pain scores during postoperative follow-up.
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Postoperative days 1, 3, and 5
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Opioid Consumption
Tidsramme: Within postoperative 24 hours
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Total postoperative opioid consumption during the early postoperative period.
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Within postoperative 24 hours
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Postoperative Nausea and Vomiting
Tidsramme: Within postoperative 24 hours
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Incidence of postoperative nausea and vomiting during the early postoperative period.
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Within postoperative 24 hours
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
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
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 25-42
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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