Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair (LIDO-TAPP)

September 1, 2026 updated by: 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey (Türkiye)
    • Istanbul
      • Istanbul, Istanbul, Turkey (Türkiye), 34668
        • University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Lidocaine
Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair.
Placebo Comparator: 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.
Drug: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Preoperative baseline and postoperative days 1, 3, 5, and 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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, 4, 6, 12, and 24 hours after surgery and postoperative days 3, 5, and 7
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.
First 24 hours after surgery
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.
First 24 hours after surgery
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.
First 24 hours after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hakan Emirkadı

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 2, 2026

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

January 31, 2027

Study Registration Dates

First Submitted

May 21, 2026

First Submitted That Met QC Criteria

May 21, 2026

First Posted (Actual)

May 29, 2026

Study Record Updates

Last Update Posted (Actual)

September 4, 2026

Last Update Submitted That Met QC Criteria

September 1, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-42

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No individual participant data will be shared because the study involves sensitive clinical data and no public data-sharing plan has been established.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe