Postoperative Fatigue Syndrome, Inguinal Hernia Unilateral
Conditions
Keywords
Intravenous Lidocaine, Postoperative Fatigue, Laparoscopic TAPP Repair, Postoperative Recovery
Brief summary
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.
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.
Interventions
DRUGLidocaine
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.
Sponsors
Hakan Emirkadı
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Masking description
Participants, anesthesia care providers, and postoperative outcome assessors will be blinded to treatment allocation. Study solutions will be prepared in identical volumes and appearance by an authorized individual not involved in postoperative outcome assessment or clinical care. Emergency unblinding will be permitted when required for participant safety.
Intervention model description
Participants will be randomly assigned to either the intravenous lidocaine group or the control group in a parallel-group design.
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MFI-20 Physical Fatigue Subscale Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity (11-point Numeric Rating Scale) | 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. |
| Postoperative Nausea and Vomiting Within 24 Hours | 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. |
| Cumulative Tramadol Consumption During the First 24 Postoperative Hours | 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. |
| Requirement for Additional Analgesia During the First 24 Postoperative Hours | 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. |
Countries
Turkey (Türkiye)
Contacts
CONTACTHakan Emirkadı, MD
Outcome results
None listed