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Intravenous Lidocaine for Postoperative Fatigue After Laparoscopic TAPP Inguinal Hernia Repair

ConditionsPostoperative Fatigue SyndromeInguinal Hernia Unilateral
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorHakan Emirkadı

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

80 Participants
are divided into 2 treatment groups
Group A: Lidocaine GroupExperimental treatment 1 intervention
Group B: Control GroupPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

MFI-20 Physical Fatigue Subscale Score

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.

Time frame
Preoperative baseline and postoperative days 1, 3, 5, and 7

Secondary outcomes

1

Postoperative Pain Intensity (11-point Numeric Rating Scale)

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.

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

Postoperative Nausea and Vomiting Within 24 Hours

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.

Time frame
First 24 hours after surgery
3

Cumulative Tramadol Consumption During the First 24 Postoperative Hours

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.

Time frame
First 24 hours after surgery
4

Requirement for Additional Analgesia During the First 24 Postoperative Hours

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.

Time frame
First 24 hours after surgery

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hakan Emirkadı

Lead sponsor

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

Sponsor institution

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: