Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

Not Applicable

Terminated

Brief Summary: 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: 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

Recruitment & Eligibility

Inclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
Lidocaine/ketamine	Lidocaine/Ketamine	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.
Placebo	placebo	General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
Ropivacaine	ropivacaine	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

Primary Outcome Measures

Name	Time	Method
Postoperative Opioid Consumption in Oral Oxycodone Equivalents	2 days after surgery	The cumulative opioid consumption after surgery until the end of second postoperative day.

Secondary Outcome Measures

Name	Time	Method
Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents	From admission to the end of surgery	The cumulative opioid consumption is calculated as fentanyl equivalent
Postoperative Nausea	After surgery until the second postoperative day.	Number of patients who had postoperative nausea or vomiting were recorded.
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	After surgery until the second postoperative mornings.	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.