Lidocaine and Ketamine in Abdominal Surgery

Study Overview
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Brief Summary
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This study is being done to determine if combined infusions of lidocaine and ketamine is better than a lidocaine or ketamine infusion alone, or to placebo in improving recovery after abdominal hysterectomy. Participants will be randomized into one of four groups. Evaluations will be done through walking tests, pain and fatigue questionnaires and blood tests.

Detailed Description
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Subjects undergoing abdominal hysterectomy surgery are randomized into one of four groups: Intravenous Lidocaine, Intravenous Ketamine, Intravenous Lidocaine and Ketamine or Placebo. Subjects will perform a six-minute walk test prior to surgery and on the second day postoperatively. After surgery and on days 1 and 2 after surgery, subjects will rate their pain. On day 1 postoperatively, subjects will rate their fatigue. On postoperative days 1 and 2 incisional pain will be analysed using von Frey filaments. Two hours after surgery, 10 ml of venous blood will be sampled for cytokine analysis. Telephone follow up will take place 6 and 12 months postoperatively to access pain and quality of life.

Official Title
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Effects of Perioperative Lidocaine and Ketamine Infusions on Acute Functional Recovery After Abdominal Hysterectomy

Conditions
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Abdominal Hysterectomy (& Wertheim)

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 years old and less than 75 years years old Horizontal abdominal incision Exclusion Criteria: Emergency or urgent procedure Preexisting chronic pain (at any site) requiring treatment Contraindication to any study medication (ketamine or lidocaine) History of significant Axis I psychiatric disease (major depressive disorder, bipolar disorder, schizophrenia, etc.) Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment Seizure disorder requiring medication within past 2 years Planned spinal or epidural anesthesia or analgesia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Lidocaine<br>Intravenous Lidocaine Group - Lidocaine is administered intravenously throughout surgery and during the 24 hours following surgery | Drug: Lidocaine<br>* Upon general anesthesia induction, lidocaine (1.5 mg/kg) will be given. Lidocaine infusion of 2 mg/kg/hour, to a maximum of 200 mg/hour during The lidocaine infusion will be reduced to 1.3 mg/kg/hour, to a maximum of 133 mg/hour, at skin closure and discontinued 24 hours postoperatively.<br>|
| Placebo Comparator: Placebo<br>A lidocaine placebo is administered intravenously throughout surgery and during the 24 hours after surgery. | Drug: Placebo<br>* Placebo boluses and infusions will be substituted<br>|
| Active Comparator: Ketamine<br>Intravenous Ketamine Group - Ketamine is administered intravenously throughout surgery and during the 24 hours following surgery | Drug: Ketamine<br>* Ketamine (0.25 mg/kg) will be given followed by an infusion of ketamine (0.25 mg/kg/hour) up to 25 mg/hour. The ketamine infusion will be reduced to 0.12 mg/kg/hour up to a maximum of 12 mg/hour at skin closure and discontinued 24 hours postoperatively.<br>|
| Active Comparator: ketamine + Lidocaine<br>both ketamine and Lidocaine are administered intravenously throughout surgery and during the 24 hours after surgery. | Drug: Ketamine + Lidocaine<br>* both Ketamine and Lidocaine will be given<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Effects of Lidocaine and Ketamine on Functional Recovery Assessed by 6 Minute Walk Test on Postoperative Day Two | The effects of lidocaine and ketamine on functional recovery assessed by 6 minute walk test on postoperative day two after hysterectomy. This outcome measures return to ambulation after surgery. | postoperative day 2 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Verbal Response Pain Scores (VRS) at PACU Admission and Discharge as Well as Mornings and Afternoons of Postoperative Days 1 and 2 | Verbal response pain scores (VRS) at PACU admission and discharge as well as mornings and afternoons of postoperative days 1 and 2. VRS scale ranges from 0 to 10, with 0 denoting no pain and 10 denoting worst possible pain. | PACU admission and discharge, postoperative mornings and afternoons on days 1 and 2 | 
| Total Opioid Consumption at PACU Admission and Discharge as Well as Mornings of Postoperative Days 1 and 2 |  | intraoperative through postoperative day 2 | 
| Presence of Nausea and Vomiting After Two Hours in the PACU and the First Postoperative Day |  | 2 hours after surgery, on postoperative day 1 | 
| Verbal Response Fatigue Score on Postoperative Day 1 | Verbal response fatigue score on postoperative day 1. Verbal response fatigue score measured on a scale ranging from 0 to 10, where 0 is no fatigue and 10 is the worst possible fatigue. | postoperative day 1 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain control, nausea, surgery recovery