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NCT Number: NCT07612839

Intravenous Lidocaine for Postoperative Fatigue After 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.

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Key information

Conditions

Postoperative Fatigue Syndrome Inguinal Hernia Unilateral

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital

Istanbul, 34668, Turkey (Türkiye)

Location contact

Hakan Emirkadı, MD

CONTACT

[email protected]

+905322609367

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

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

Drug

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.

Primary outcomes

  1. MFI-20 Physical Fatigue Subscale Score

    Time frame: 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.

Secondary outcomes

  1. Postoperative Pain Intensity (11-point Numeric Rating Scale)

    Time frame: 2, 4, 6, 12, and 24 hours after surgery and postoperative days 3, 5, and 7

    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.

  2. Postoperative Nausea and Vomiting Within 24 Hours

    Time frame: First 24 hours after surgery

    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.

  3. Cumulative Tramadol Consumption During the First 24 Postoperative Hours

    Time frame: First 24 hours after surgery

    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.

  4. Requirement for Additional Analgesia During the First 24 Postoperative Hours

    Time frame: First 24 hours after surgery

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Hakan Emirkadı, MD

CONTACT

[email protected]

+905322609367

Sponsors and collaborators

Lead sponsor

Hakan Emirkadı

Other

Registry information

Official study title

The Effect of Intravenous Lidocaine on Postoperative Fatigue Syndrome in Patients Undergoing Elective Laparoscopic TAPP Inguinal Hernia Repair

Acronym: LIDO-TAPP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 29, 2026
Registry last updated
Sep 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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