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This study aims to evaluate the analgesic and anti-inflammatory effect of perioperative intravenous lidocaine infusion and in turn the return of gastric motility in patients undergoing elective laparoscopic cholecystectomy.
Laparoscopic cholecystectomy is considered a minimally invasive procedure; however, it still provokes a measurable systemic inflammatory response. This reaction is primarily driven by factors such as tissue manipulation, peritoneal insufflation, and surgical stress. C-reactive protein (CRP), a widely validated acute-phase reactant, serves as a reliable biomarker to monitor postoperative inflammation, typically peaking within 24 to 48 hours following surgery. Other inflammatory markers such as white blood cell (WBC) count, neutrophil-to-lymphocyte ratio (NLR), and interleukin-6 (IL-6) also exhibit perioperative changes, reflecting the underlying cytokine-mediated stress response. Monitoring these biomarkers provides insight into the extent of tissue injury and can help predict postoperative recovery or complications. Therefore, modulating the inflammatory response-such as through intravenous lidocaine infusion-may improve postoperative outcomes, including pain control, gastrointestinal recovery, and length of hospital stay.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group L | Active Comparator | IV Lidocaine infusion: |
|
| Group C | Placebo Comparator | IV normal saline |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IV Lidocaine infusion | Drug | 2 mg/kg/h (the total dose of lidocaine per hour will be calculated and add to normal saline 0.9% to total volume 50 ml and infused by a rate 50 ml/h till the end of the procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative CRP level | measurement of Postoperative CRP level | postoperative day 1 (24 hours postoperative) |
| Measure | Description | Time Frame |
|---|---|---|
| Pain scores (VNS) | verbal numerical scale from 0-10. (0 = no pain, 10 = worst imaginable pain The patient verbally reports the number that best reflects their pain intensity. | 2, 6, 12, 24 hours |
| GIT motility |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Noha Y Mohammed, MD | Contact | +201001890194 | noha.hagagy@gmail.com | |
| Afaf R Youssef, MBBCH | Contact | 01207787689 | +2 | aymansamaan214@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Noha Y Mohamed, MD | Lecturer in anesthesia and intensive care department, faculty of medicine, | Principal Investigator |
| Noha Y Mohammed, MD | Lecturer in anesthesia and intensive care department, faculty of medicine, |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Assiut university main hospital | Asyut | Assiut Governorate, Egypt, | 71515 | Egypt |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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group L: lidocaine IV infusion group C: normal saline 0.9% IV infusion
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double blinded
| IV normal saline | Drug | IV normal saline 0.9% , rate 50 ml/h |
|
Time to first pass of faeces or flatus/bowel movement
| within 24 hours |
| Postoperative complications | nausea, vomiting, ileus, infection | within 48 hours |
| Time to ambulation | time of patient discharge from the hospital | within 48 hours |