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Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

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ClinicalTrials.gov Identifier: NCT00720330
Recruitment Status : Terminated (Enrollment challenges prohibited study progression.)
First Posted : July 22, 2008
Results First Posted : May 19, 2017
Last Update Posted : March 12, 2019
Sponsor:
Information provided by (Responsible Party):
Kenneth Cummings III, MD, MS, The Cleveland Clinic

Tracking Information
First Submitted Date  ICMJE July 21, 2008
First Posted Date  ICMJE July 22, 2008
Results First Submitted Date  ICMJE April 14, 2017
Results First Posted Date  ICMJE May 19, 2017
Last Update Posted Date March 12, 2019
Study Start Date  ICMJE July 2008
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: July 21, 2008)
Postoperative analgesic consumption in oral oxycodone equivalents [ Time Frame: 3 and 6 months post-operatively ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 21, 2008)
  • 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 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
Official Title  ICMJE The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Pain
  • Nausea
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: April 14, 2017)
12
Original Estimated Enrollment  ICMJE
 (submitted: July 21, 2008)
486
Actual Study Completion Date  ICMJE February 2010
Actual Primary Completion Date February 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00720330
Other Study ID Numbers  ICMJE 08-385
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kenneth Cummings III, MD, MS, The Cleveland Clinic
Study Sponsor  ICMJE The Cleveland Clinic
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Kenneth Cummings, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
PRS Account The Cleveland Clinic
Verification Date March 2019

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