Intravenous Lidocaine and Postoperative Pain Management

Study Overview
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Brief Summary
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This study was to evaluate the effect of intraoperative intravenous lidocaine on postoperative pain management after laparoscopic cholecystectomy. Half of patients will receive intravenous lidocaine during procedure, the rest half of patients will receive regular anesthesia care and placebo treatment.

Detailed Description
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Postoperative pain and ileus are primary reasons for delayed patient recovery and longer hospital stays after abdominal surgery. Opioids have been widely used to treat pain in this patient population. However, opioid administration can exacerbate postoperative ileus and further delay patient recovery. Multimodal approaches and adjunctive therapies are therefore recommended for pain control after abdominal surgery to reduce opioid consumption and opioid-related adverse effects. Studies have reported that systemically administered lidocaine has analgesic, anti-inflammatory, and anti-hyperalgesic effects. Several clinical trials have been published that evaluated systemically administered lidocaine for postoperative pain management and recovery after surgery. However, the evidence for beneficial effects of systemic lidocaine for postoperative recovery remains controversial. Therefore, the investigators performed this study to evaluate the efficacy of systemic administration of lidocaine for postoperative analgesia and gastrointestinal recovery after laparoscopic cholecystectomy. The investigators primary hypothesis is that systemic lidocaine administration reduces pain intensity following surgery.

Official Title
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Effect of Intravenous Lidocaine on Postoperative Pain Management After Laparoscopy Cholecystectomy

Conditions
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Postoperative Pain Management

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Saline Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anesthesiologist (ASA) status I-II adult patients undergoing elective laparoscopic cholecystectomy. Exclusion Criteria: Open surgery; Patients allergic to lidocaine or other local anesthetics; Drug abuser.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intravenous lidocaine<br>intravenous lidocaine 1.5mg/kg during induction then infused at 2mg/kg/h until the end of procedure. | Drug: Lidocaine<br>* lidocaine infusion during surgery<br>|
| Placebo Comparator: saline placebo<br>same amount volume saline infusion | Drug: Saline Placebo<br>* saline infusion at same rate as intervention group during surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain score | visual analogue score (1-10) | 6 hours after surgery | 
| postoperative pain score | visual analogue score (1-10) | 24 hours after surgery | 
| postoperative pain score | visual analogue score (1-10) | 72 hours after surgery | 
| total postoperative opioid consumption | postoperative fentanyl consumption | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative complication | opioid-related side effects, such as nausea and vomiting, and the incidence of adverse effects associated with systemic administration of lidocaine. | 48 hours after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous lidocaine, postoperative pain management