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.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
80
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 will be administered intravenously as placebo in an equal volume and according to the same timing and infusion protocol as the lidocaine intervention.
University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital
Istanbul, Istanbul, Turkey (Türkiye)
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
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
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
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
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
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