Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

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

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.

Study Overview

• Status: Terminated
• Conditions: Pain; Nausea
• Intervention / Treatment: Other: placebo; Drug: ropivacaine; Drug: Lidocaine/Ketamine

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

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Mayfield Heights, Ohio, United States, 44124
      • Cleveland Clinic/Hillcrest Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: ropivacaine; 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
Active Comparator: 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.	Drug: Lidocaine/Ketamine; 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).
Placebo Comparator: Placebo; General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery	Other: placebo; placebo

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: The Cleveland Clinic
• Investigators: Principal Investigator: Kenneth Cummings, MD, The Cleveland Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2008
• Primary Completion (Actual): February 1, 2010
• Study Completion (Actual): February 1, 2010

Study Registration Dates

• First Submitted: July 21, 2008
• First Submitted That Met QC Criteria: July 21, 2008
• First Posted (Estimate): July 22, 2008

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Keywords: Outcomes; Pain assessment; Inguinal Herniorrhaphy
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Chronic Pain; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Ketamine; Lidocaine; Ropivacaine
• Other Study ID Numbers: 08-385