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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocaine Group | Experimental | 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. |
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| Control Group | No Intervention | Participants in this group will receive standard perioperative care without intravenous lidocaine infusion during elective laparoscopic TAPP inguinal hernia repair. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug | Perioperative intravenous lidocaine infusion will be administered according to the study protocol in patients undergoing elective laparoscopic TAPP inguinal hernia repair. |
| 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 |
| 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. |
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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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hakan Emirkadı, MD | Contact | +905322609367 | hemirkadi@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Health Sciences Sultan Abdulhamid Han Training and Research Hospital | Istanbul | Istanbul | 34668 | Turkey (Türkiye) |
No individual participant data will be shared because the study involves sensitive clinical data and no public data-sharing plan has been established.
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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Participants will be randomly assigned to either the intravenous lidocaine group or the control group in a parallel-group design.
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| Within postoperative 24 hours |
| Postoperative Nausea and Vomiting | Incidence of postoperative nausea and vomiting during the early postoperative period. | Within postoperative 24 hours |
| Aniline Compounds |
| D000588 | Amines |