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Sponsored by: |
Outcomes Research Consortium |
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Information provided by: | Outcomes Research Consortium |
ClinicalTrials.gov Identifier: | NCT00720330 |
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 |
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Pain Nausea |
Drug: ropivacaine Drug: Lidocaine/Ketamine Other: placebo |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
Official Title: | The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy |
Estimated Enrollment: | 486 |
Study Start Date: | July 2008 |
Estimated Study Completion Date: | October 2009 |
Estimated Primary Completion Date: | July 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Group 1: Active Comparator
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
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Group 2: Active Comparator
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.
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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).
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Group 3: Placebo Comparator
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
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Other: placebo
placebo
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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
Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kenneth Cummings, MD | 440-312-5259 | cummink2@ccf.org |
Contact: Nancy Graham, BA.CCRP | 216-445-7530 | grahamn@ccf.org |
United States, Ohio | |
Cleveland Clinic/Hillcrest Hospital | Recruiting |
Mayfield Heights, Ohio, United States, 44124 | |
Contact: Kenneth Cummings, MD 440-312-5259 cummink2@ccf.org |
Principal Investigator: | Kenneth Cummings, MD | Cleveland Clinic |
Study Chair: | Daniel I Sessler, MD | Cleveland Clinic |
Responsible Party: | Cleveland Clinic ( Kenneth Cummings, MD ) |
Study ID Numbers: | 08-385 |
Study First Received: | July 21, 2008 |
Last Updated: | February 4, 2009 |
ClinicalTrials.gov Identifier: | NCT00720330 History of Changes |
Health Authority: | United States: Institutional Review Board |
Inguinal Herniorrhaphy Pain assessment Outcomes |
Anesthetics, Intravenous Excitatory Amino Acids Neurotransmitter Agents Fentanyl Ropivacaine Lidocaine Central Nervous System Depressants Anesthetics Pain Cardiovascular Agents Midazolam |
Anesthetics, Local Anesthetics, Dissociative Anesthetics, General Ketamine Nausea Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Propofol Epinephrine |
Anesthetics, Intravenous Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Ropivacaine Physiological Effects of Drugs Lidocaine Anesthetics Central Nervous System Depressants Excitatory Amino Acid Agents Cardiovascular Agents Anesthetics, Local |
Anesthetics, Dissociative Pharmacologic Actions Sensory System Agents Anesthetics, General Therapeutic Uses Ketamine Anti-Arrhythmia Agents Peripheral Nervous System Agents Analgesics Central Nervous System Agents Excitatory Amino Acid Antagonists |