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Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

This study has been terminated.
(Enrollment challenges prohibited study progression.)
Sponsor:
Information provided by (Responsible Party):
Kenneth Cummings III, MD, MS, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00720330
First received: July 21, 2008
Last updated: April 14, 2017
Last verified: April 2017
July 21, 2008
April 14, 2017
July 2008
February 2010   (Final data collection date for primary outcome measure)
Postoperative Opioid Consumption in Oral Oxycodone Equivalents [ Time Frame: 2 days after surgery ]
The cumulative opioid consumption after surgery until the end of second postoperative day.
Postoperative analgesic consumption in oral oxycodone equivalents [ Time Frame: 3 and 6 months post-operatively ]
Complete list of historical versions of study NCT00720330 on ClinicalTrials.gov Archive Site
  • Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents [ Time Frame: From admission to the end of surgery ]
    The cumulative opioid consumption is calculated as fentanyl equivalent
  • Time From the End of Surgery to Readiness for Hospital Discharge. [ Time Frame: Until hospital discharge, assessed up to 6 months ]
  • Pain Scores on Numerical Rating Scale [ Time Frame: After surgery until the second postoperative mornings. ]
    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.
  • Postoperative Nausea [ Time Frame: After surgery until the second postoperative day. ]
    Number of patients who had postoperative nausea or vomiting were recorded.
  • Pre and intraoperative analgesic consumption in fentanyl equivalents [ Time Frame: 3 and 6 months post-operatively ]
  • Time from end of surgery to readiness for hospital discharge. [ Time Frame: number of days to hospital discharge ]
  • Verbal response pain scores [ Time Frame: PACU admission and discharge,first and second postoperative mornings. ]
  • Incidence of postoperative nausea [ Time Frame: Day 1 and day 2 post-operatively ]
Not Provided
Not Provided
 
Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
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.
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
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
  • Pain
  • Nausea
  • Drug: ropivacaine
    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
  • Drug: Lidocaine/Ketamine
    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).
  • Other: placebo
    placebo
  • Active Comparator: Ropivacaine
    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
    Intervention: Drug: ropivacaine
  • Active Comparator: Lidocaine/ketamine
    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.
    Intervention: Drug: Lidocaine/Ketamine
  • Placebo Comparator: Placebo
    General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
    Intervention: Other: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
12
February 2010
February 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: Male
18 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00720330
08-385
No
Not Provided
Not Provided
Kenneth Cummings III, MD, MS, The Cleveland Clinic
The Cleveland Clinic
Not Provided
Principal Investigator: Kenneth Cummings, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
The Cleveland Clinic
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP