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

This prospective randomized controlled study aims to evaluate the effect of perioperative intravenous lidocaine infusion on postoperative fatigue syndrome in patients undergoing elective laparoscopic TAPP inguinal hernia repair. Participants will be randomly assigned to receive either intravenous lidocaine infusion or standard perioperative management without lidocaine. The primary objective is to assess postoperative fatigue and recovery quality. Secondary outcomes include postoperative pain, analgesic consumption, nausea-vomiting, mobilization time, and length of hospital stay.

Study Overview

• Status: Not yet recruiting
• Conditions: Inguinal Hernia Unilateral; Postoperative Fatigue Syndrome
• Intervention / Treatment: Drug: Lidocaine

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hakan Emirkadı, MD; Phone Number: +905322609367; Email: hemirkadi@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul
    • Istanbul, Istanbul, Turkey (Türkiye), 34668
      • University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital
      • Contact: Hakan Emirkadı, MD; Phone Number: +905322609367; Email: hemirkadi@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Lidocaine; Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair.
No Intervention: Control Group; Participants in this group will receive standard perioperative care without intravenous lidocaine infusion during elective laparoscopic TAPP inguinal hernia repair.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Fatigue Syndrome Score	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.	Postoperative days 1, 3, 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative Pain Score	Assessment of postoperative pain scores during postoperative follow-up.	Postoperative days 1, 3, and 5
Opioid Consumption	Total postoperative opioid consumption during the early postoperative period.	Within postoperative 24 hours
Postoperative Nausea and Vomiting	Incidence of postoperative nausea and vomiting during the early postoperative period.	Within postoperative 24 hours

Collaborators and Investigators

• Sponsor: Hakan Emirkadı

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): September 10, 2026

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): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Postoperative Recovery; Intravenous Lidocaine; Postoperative Fatigue; Laparoscopic TAPP Repair
• Additional Relevant MeSH Terms: Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine
• 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