Clinical trial NCT00720330: Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
Official title: The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Pain
Nausea
Keywords: Inguinal Herniorrhaphy
Pain assessment
Outcomes
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2008-07-22
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative Opioid Consumption in Oral Oxycodone Equivalents
timeFrame: 2 days after surgery
Secondary outcomes:
measure: Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
timeFrame: From admission to the end of surgery
measure: Time From the End of Surgery to Readiness for Hospital Discharge.
timeFrame: Until hospital discharge, assessed up to 6 months
measure: Pain Scores on Numerical Rating Scale
timeFrame: After surgery until the second postoperative mornings.
measure: Postoperative Nausea
timeFrame: After surgery until the second postoperative day.
Other outcomes:
Locations:
city: Mayfield Heights
country: United States
facility: Cleveland Clinic/Hillcrest Hospital
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kenneth Cummings, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: The Cleveland Clinic
name: Daniel I Sessler, MD
role: STUDY_CHAIR
References: