Enhanced Recovery After Anesthesia
Conditions
Brief summary
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.
Detailed description
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.
Interventions
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
DRUGIV normal saline
IV normal saline 0.9% , rate 50 ml/h
Sponsors
Assiut University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
double blinded
Intervention model description
group L: lidocaine IV infusion group C: normal saline 0.9% IV infusion
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Patients aged 18 - 60 years 2. Elective laparoscopic cholecystectomy for symptomatic cholelithiasis or chronic cholecystitis 3. ASA physical status I-II 4. BMI \< 35 kg/m2 5. Preoperative CRP \<20 mg/L 6. Informed consent provided
Exclusion criteria
1. Acute cholecystitis or biliary pancreatitis 2. Conversion to open surgery 3. Pre-op CRP \>20 mg/L 4. Allergy to lidocaine or local anesthetics 5. Known hepatic or renal dysfunction 6. Chronic inflammatory conditions 7. Current immunosuppressive therapy 8. Cardiac arrhythmias or heart block without pacemaker 9. ASA physical status III, IV or above 10. Pregnancy or breastfeeding 11. Psychiatric disorders
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative CRP level | postoperative day 1 (24 hours postoperative) | measurement of Postoperative CRP level |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain scores (VNS) | 2, 6, 12, 24 hours | 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. |
| GIT motility | within 24 hours | Time to first pass of faeces or flatus/bowel movement |
| Postoperative complications | within 48 hours | nausea, vomiting, ileus, infection |
| Time to ambulation | within 48 hours | time of patient discharge from the hospital |
Countries
Egypt
Contacts
Primary ContactNoha Y Mohammed, MD
Backup ContactAfaf R Youssef, MBBCH
Outcome results
None listed