This site became the new ClinicalTrials.gov on June 19th. Learn more.
Show more
ClinicalTrials.gov Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more...
ClinicalTrials.gov Menu
Give us feedback

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
  Purpose
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.

Condition Intervention
Pain Nausea Drug: ropivacaine Drug: Lidocaine/Ketamine Other: placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Care Provider, Investigator, Outcomes Assessor
Primary Purpose: Treatment
Official Title: The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy

Resource links provided by NLM:


Further study details as provided by Kenneth Cummings III, MD, MS, The Cleveland Clinic:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Enrollment: 12
Study Start Date: July 2008
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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
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.
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).
Placebo Comparator: Placebo
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
Other: placebo
placebo

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

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00720330

Locations
United States, Ohio
Cleveland Clinic/Hillcrest Hospital
Mayfield Heights, Ohio, United States, 44124
Sponsors and Collaborators
The Cleveland Clinic
Investigators
Principal Investigator: Kenneth Cummings, MD The Cleveland Clinic
Study Chair: Daniel I Sessler, MD The Cleveland Clinic
  More Information

Responsible Party: Kenneth Cummings III, MD, MS, Principal Investigator, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00720330     History of Changes
Other Study ID Numbers: 08-385
Study First Received: July 21, 2008
Results First Received: April 14, 2017
Last Updated: April 14, 2017

Keywords provided by Kenneth Cummings III, MD, MS, The Cleveland Clinic:
Inguinal Herniorrhaphy
Pain assessment
Outcomes

Additional relevant MeSH terms:
Chronic Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Lidocaine
Ropivacaine
Ketamine
Fentanyl
Midazolam
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Analgesics
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Analgesics, Opioid
Narcotics

ClinicalTrials.gov processed this record on July 27, 2017