Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
| Status: | Terminated |
|---|---|
| Conditions: | Chronic Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 3/14/2019 |
| Start Date: | July 2008 |
| End Date: | February 2010 |
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.
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.
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
- 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
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
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