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Sponsors and Collaborators: |
University Hospital Muenster International Anesthesia Research Society (IARS) |
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Information provided by: | University Hospital Muenster |
ClinicalTrials.gov Identifier: | NCT00413127 |
The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery
Condition | Intervention | Phase |
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Elective Surgical Procedure Colorectal Surgery |
Drug: lidocaine Drug: NaCl 0,9% |
Phase II Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration |
Estimated Enrollment: | 150 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | March 2011 |
Estimated Primary Completion Date: | September 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Lidocaine i.v
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Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
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2: Active Comparator
intraoperatively lidocaine epidural postoperatively lidocaine i.v.
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Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
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3: Active Comparator
intraoperatively lidocaine i.v. postoperatively lidocaine epidural
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Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
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4: Active Comparator
lidocaine epidural
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Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
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5: Placebo Comparator
placebo i.v.
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Drug: NaCl 0,9%
Administration of placebo i.v.
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Ages Eligible for Study: | 18 Years to 75 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: C Hoenemann, MD | +49-4441-99-0 |
Germany | |
St. Marienhospital | Recruiting |
Vechta, Germany, D-49377 | |
Contact: C Hoenemann, MD +49-4441-99-0 | |
Principal Investigator: C Hoenemann, MD | |
University Hospital Muenster | Recruiting |
Muenster, Germany, D-48129 | |
Contact: K Hahnenkamp, MD +49-251-834-7255 | |
Principal Investigator: K Hahnenkamp, MD |
Study Chair: | K Hahnenkamp, MD | Department of Anesthesiology and Intensive Care, University Hospital Muenster |
Responsible Party: | Department of Anesthesiology and Intensive Care, University Hospital Muenster ( Hahnenkamp, MD / Principle investigator ) |
Study ID Numbers: | 06-AnIt-06 |
Study First Received: | December 18, 2006 |
Last Updated: | May 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00413127 History of Changes |
Health Authority: | Germany: Federal Institute for Drugs and Medical Devices |
Systemic lidocaine peridural lidocaine perioperative analgesia inflammation Anesthesia |
Lidocaine Central Nervous System Depressants Anesthetics Cardiovascular Agents |
Anti-Arrhythmia Agents Peripheral Nervous System Agents Anesthetics, Local Inflammation |
Sensory System Agents Therapeutic Uses Physiological Effects of Drugs Lidocaine Central Nervous System Depressants Anesthetics |
Cardiovascular Agents Anti-Arrhythmia Agents Peripheral Nervous System Agents Central Nervous System Agents Pharmacologic Actions Anesthetics, Local |