Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy

Study Overview
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Brief Summary
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Open nephrectomy is one of the most common surgical procedures in urologic practice. Pain after surgery remains a significant clinical problem as it impairs recovery adversely and may lead to the transition to chronic pain. The open approach represents a major physical trauma including postoperative pain and discomfort in the convalescence period. Adequate control of postoperative pain facilitates earlier mobilization and rehabilitation. Patient-controlled analgesia (PCA) is effective to treat pain at rest, but seems to be inadequate for dynamic analgesia and may also elicit side effects that may delay hospital discharge. Preventing early and late postsurgical pain is an important challenge for anesthesiologists and surgeons. Ketamine (N-Methyl-D-Aspartate receptor antagonist) and lidocaine (sodium channel blocker) are popular analgesic adjuvants for improving perioperative pain management. The investigators designed this double-blind, placebo controlled study to test and compare the preventive effects of perioperative intravenous ketamine and lidocaine on early and chronic pain after elective open nephrectomy. The investigators propose a double-blind placebo-controlled study of patients undergoing elective open nephrectomy. All patients will receive normal patient-controlled analgesia morphine in addition to study drugs or placebo. Research will be conducted at Charles Nicolle teaching hospital.

Detailed Description
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Participants will be randomized into one of three study groups: Group L: intravenous lidocaine: bolus of 1.5 mg/kg at induction of anesthesia followed by infusion of 1 mg/kg/h intraoperatively and for 24 h postoperatively. Group K: Ketamine: bolus of 0.15 mg/kg followed by infusion of 0.1 mg/kg/h intraoperatively and for 24 h postoperatively. Control Group C: an equal volume of saline. The anesthetic technique will be standardized, and the postoperative assessments included pain scores, opioid consumption, recovery of bowel function and 6-minute walk distance (6-MWD) on the fourth postoperative morning. At 3 months, patients will be questioned for chronic postoperative pain using the Neuropathic Pain 4 questionnaire.

Official Title
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A Comparison Between the Effects of Perioperative Intravenous Lidocaine and Ketamine on Acute and Chronic Pain After Open Nephrectomy: A Prospective, Double-blind, Randomized, Placebo Controlled Study

Conditions
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Postoperative Pain

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult (>/=18) male or female Undergoing elective open nephrectomy General anesthesia Subject is American Society of Anesthesiologists (ASA) physical status 1 or 2. Exclusion Criteria: Pregnancy and breastfeeding Cognitively impaired (by history) Subject with a history of psychosis Subject known to have significant hepatic disease History of previous cardiac arrhythmia Subject for whom opioids or ketamine are contraindicated

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketamine<br>Ketamine infused at 0.1 mg/kg/hour | Drug: Ketamine<br>* Ketamine infused at 0.1 mg/kg/hour<br>|
| Experimental: Lidocaine<br>Lidocaine infused at 1 mg/kg/hour | Drug: Lidocaine<br>* Lidocaine infused at 1 mg/kg/hour<br>|
| Placebo Comparator: Placebo<br>An equal volume of saline | Drug: Placebo<br>* An equal volume of saline<br>* Other names: Saline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total opioid consumption | the total amount of morphine consumed during follow up period | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative nausea and vomiting using a Verbal Rating Scale | Investigators will ask patients to grade the severity of their nausea and vomiting episodes using a verbal rating scale | 48 hours | 
| Functional recovery assessed by 6 minute walk test (6MWT) |  | the fourth postoperative morning | 
| chronic postoperative pain assessed by the Neuropathic Pain 4 questionnaire. (NP4) |  | At 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ketamine, Lidocaine, Nephrectomy, Chronic pain