A Phase 3 interventional study of Lidocaine Infusion and saline Infusion in Elective Major Abdominal Surgery, sponsored by Mansoura University. Completed at 1 site in Egypt. Open to participants aged 1 Year to 6 Years. Per ClinicalTrials.gov, last updated 2012-04-20.
Sponsored by Mansoura University · Phase 3, Interventional, and Prevention
In this study, the investigators hypothesized that perioperative i.v. infusion of lidocaine in major abdominal pediatric surgery, may have a beneficial effect on hemodynamic and hormonal responses. Also, it could decrease the hospital stay, opioid requirement and hasten return of bowel function.
The inflammatory response after major abdominal surgery is of great importance for patients, physicians and perioperative medicine1. Perioperative excessive stimulation of the inflammatory and hemostatic systems may result in development of postoperative ileus, ischemia-reperfusion syndromes, hypercoagulation syndromes (e.g. deep venous thrombosis) and pain excessive inflammatory response such as impaired gastrointestinal motility, so modulation of inflammatory responses may decrease severity of such complications 2,3.
Intravenous lidocaine, a local anesthetic, has been shown to improve postoperative analgesia, reduce postoperative opioid requirements, accelerate postoperative recovery of bowel function, attenuate postoperative fatigue, reduced the duration of hospitalization, and facilitate acute rehabilitation in patients undergoing laparoscopic abdominal surgery 4. Administration of local anesthetics to epidural space has analgesic effect, blunt stress response; provide rapid mobilization, early extubation with rapid recovery of bowel function 5. However, insertion of an epidural catheter carries risks especially in pediatric populations. So, systemic lidocaine may become another strategy for improving perioperative outcome which is safe and effective2.
Mansoura University is the lead sponsor of 1,077 studies on the registry; 183 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Lidocaine group
Drug: Lidocaine Infusion
Placebo group
Drug: saline Infusion
children in group L received i.v. lidocaine 1.5 mg/kg followed by infusion at 1.5 mg. kg-1.h-1. and were continued up to 6 hours postoperatively
children in group P received i.v. saline 0.9% 1 ml/kg followed by infusion at 0.1 ml. kg-1.h-1,and were continued up to 6 hours postoperatively
Blood pressure
Time frame: for 2hrs after infusion
Plasma Cortisol
Time frame: for 24 hrs after infusion
Serum lidocaine
The TDx/ TDx FLx (Abbot Diagnostic, USA) lidocaine assay was used for quantitative measurement of serum lidocaine
Time frame: 6 hrs after infusion
Heart rate (HR)
Time frame: for 6 hrs after infusion
Pain scales
In the postanaesthetic care unit (PACU), children were assessed for pain every 10 min by the trained nurse blinded to group assignment, using 1 of 2 pain scales according to child comprehension: a 0- to 10-point visual analog scale (VAS), or FLACC Scale (Face, Legs,Activity, Cry, Consolability). FLACC is an observer assessment based 5 items and each item is graded from 0 to 2
Time frame: 24 hrs postoperative
This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.
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Mansoura University