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Starting soon Not applicable

Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair

NCT07612839 · tracked via the Priya Life Science Turkey tracker
Sponsor
Hakan Emirkadı
Phase
Not applicable
Started
2026-09-02
Last updated
2026-09-04

Condition(s) studied

Postoperative Fatigue SyndromeInguinal Hernia Unilateral

Investigational drug(s) / intervention(s)

Lidocaine →0.9 % sodium chloride

Lidocaine: Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair.

0.9 % sodium chloride: 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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • MFI-20 Physical Fatigue Subscale Score — Preoperative baseline and postoperative days 1, 3, 5, and 7
    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.

Trial sites (1)

FacilityCityRegionStatus
University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital Istanbul Istanbul
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07612839 on ClinicalTrials.gov ↗ ← All trials in Turkey