Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

Study Overview
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Brief Summary
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The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term.

Detailed Description
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Participants will be randomized into one of three study groups; Group 1 - Paravertebral Group - ropivacaine is injected near the spine before surgery. Midazolam and fentanyl are administered intravenously for sedation. Group 2 - Lidocaine/Ketamine - General anesthesia with lidocaine and ketamine administered intravenously throughout your surgery and for 60 minutes after surgery. Group 3 - General Anesthesia Alone. General anesthesia with placebo administered intravenously throughout surgery and for 60 minutes after surgery. All participants will rate their pain on a scale from 0 to 10 after surgery and on days 1 and 2 after surgery. Participants are called 3 and 6 months after surgery for pain and quality of life assessments

Official Title
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The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy

Conditions
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Pain, Nausea

Intervention / Treatment
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* Drug: ropivacaine
* Drug: Lidocaine/Ketamine
* Other: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age greater than 18 and less than 75 years Male Unilateral inguinal hernia scheduled for elective open repair Exclusion Criteria: Incarcerated hernia or urgent procedure Reoperation (recurrent hernia) Contraindication to regional anesthesia such as: Coagulopathy Infection at the site of needle insertion Pre-existing chronic pain (at any site) requiring treatment Contraindication to any study medication (local anesthetic or ketamine) 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

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

Sexes Eligible for Study
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Male

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 |
| --- | --- |
| Active Comparator: Ropivacaine<br>Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation | Drug: ropivacaine<br>* 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation<br>|
| Active Comparator: Lidocaine/ketamine<br>Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery. | Drug: Lidocaine/Ketamine<br>* Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).<br>|
| Placebo Comparator: Placebo<br>General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery | Other: placebo<br>* placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Opioid Consumption in Oral Oxycodone Equivalents | The cumulative opioid consumption after surgery until the end of second postoperative day. | 2 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents | The cumulative opioid consumption is calculated as fentanyl equivalent | From admission to the end of surgery | 
| Time From the End of Surgery to Readiness for Hospital Discharge. |  | Until hospital discharge, assessed up to 6 months | 
| Pain Scores on Numerical Rating Scale | Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings. | After surgery until the second postoperative mornings. | 
| Postoperative Nausea | Number of patients who had postoperative nausea or vomiting were recorded. | After surgery until the second postoperative day. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inguinal Herniorrhaphy, Pain assessment, Outcomes