Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

NeuroTherapia, Inc.

Status: Terminated

Conditions: Nausea; Pain

Treatments: Other: placebo; Drug: ropivacaine; Drug: Lidocaine/Ketamine

Study type: Interventional

Funder types: Other

Identifiers

NCT00720330

08-385

Details and patient eligibility

About

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.

Full 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

Enrollment: 12 patients

Sex: Male

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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12 participants in 3 patient groups, including a placebo group

Ropivacaine

Active Comparator group

Description:

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

Treatment:

Drug: ropivacaine

Lidocaine/ketamine

Active Comparator group

Description:

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.

Treatment:

Drug: Lidocaine/Ketamine

Placebo

Placebo Comparator group

Description:

General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery

Treatment:

Other: placebo