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Mayfield Heights, Ohio 44124


Purpose:

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 summary:

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


Criteria:

Inclusion Criteria: - Age greater than 18 and less than 75 years - 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


NCT ID:

NCT00720330


Primary Contact:

Principal Investigator
Kenneth Cummings, MD
The Cleveland Clinic


Backup Contact:

N/A


Location Contact:

Mayfield Heights, Ohio 44124
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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