Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

Ketamine

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.

Intervention / Treatment

  • Ropivacaine (DRUG)
    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
  • Lidocaine/Ketamine (DRUG)
    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 (OTHER)
    placebo

Condition or Disease

  • Pain
  • Nausea

Phase

  • Not Applicable

    • Study Design

    Study type: INTERVENTIONAL
    Status: Terminated
    Study results: No Results Available
    Age: 18 Years to 75 Years
    Enrollment: 12 (ACTUAL)
    Funded by: Other
    Allocation: Randomized
    Primary Purpose: Treatment

    Masking

    QUADRUPLE:
    • Participant
    • Care Provider
    • Investigator
    • Outcomes Assessor

    Clinical Trial Dates

    Start date: Jul 01, 2008
    Primary Completion: Feb 01, 2010 ACTUAL
    Completion Date: Feb 01, 2010 ACTUAL
    Study First Posted: Jul 22, 2008 ESTIMATED
    Results First Posted: May 19, 2017 ACTUAL
    Last Updated: Mar 08, 2019

    Sponsors / Collaborators

    Lead Sponsor: The Cleveland Clinic
    Responsible Party: N/A

    Location

    Mayfield Heights, Ohio, USA

    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

    Participant Groups

    • 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

    • 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.

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

    Eligibility Criteria

    Sex: Male
    Minimum Age: 18
    Maximum Age: 75
    Age Groups: Adult / Older Adult
    Healthy Volunteers: Yes

    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

    • The cumulative opioid consumption after surgery until the end of second postoperative day.

    Secondary Outcomes

    • The cumulative opioid consumption is calculated as fentanyl equivalent

    • Time From the End of Surgery to Readiness for Hospital Discharge. Until hospital discharge, assessed up to 6 months

    • 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.

    • Number of patients who had postoperative nausea or vomiting were recorded.

    More Details

    NCT Number: NCT00720330
    Other IDs: 08-385
    Study URL: https://clinicaltrials.gov/study/NCT00720330
    Last updated: Sep 29, 2023