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Perioperative Protective Effects of Lidocaine

This study has been terminated.
(Less patients than expected for inclusion, therefore patient recruitment is to low)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00413127
First Posted: December 19, 2006
Last Update Posted: June 26, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
International Anesthesia Research Society (IARS)
Information provided by (Responsible Party):
University Hospital Muenster
  Purpose
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
Elective Surgical Procedure Colorectal Surgery Drug: lidocaine Drug: NaCl 0,9% Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration

Resource links provided by NLM:


Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • length of postoperative hospital stay [ Time Frame: end of hospital stay ]

Secondary Outcome Measures:
  • Hyperalgesia perioperative [ Time Frame: postoperative day 2, 4, 8, end of hospital stay and follow-up ]
  • Cytokine levels perioperative [ Time Frame: before surgery and 4 hours, 2 and 4 days after surgery ]
  • Bowel motility perioperative [ Time Frame: days after surgery ]
  • Length of PACU stay [ Time Frame: end of PACU stay ]
  • Cognitive function perioperatively [ Time Frame: before surgery, one and four days after surgery, at end of hospital stay and follow-up ]
  • Incidence of wound healing disturbances [ Time Frame: within 4 weeks after surgery ]
  • Postoperative Analgesia [ Time Frame: until end of hospital stay ]

Enrollment: 78
Study Start Date: September 2007
Study Completion Date: March 2015
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Lidocaine i.v
Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
Active Comparator: 2
intraoperatively lidocaine epidural postoperatively lidocaine i.v.
Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
Active Comparator: 3
intraoperatively lidocaine i.v. postoperatively lidocaine epidural
Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
Active Comparator: 4
lidocaine epidural
Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
Placebo Comparator: 5
placebo i.v.
Drug: NaCl 0,9%
Administration of placebo i.v.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • elective colorectal surgery

Exclusion Criteria:

  • ASA > 3
  • history of anti-inflammatory therapy
  • history of inflammatory bowl diseases
  • history of chronic pain treatment
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00413127


Locations
Germany
University Hospital Muenster
Muenster, Germany, D-48129
St. Franziskushospital Muenster
Muenster, Germany, D-48145
St. Marienhospital
Vechta, Germany, D-49377
Sponsors and Collaborators
University Hospital Muenster
International Anesthesia Research Society (IARS)
Investigators
Study Chair: K Hahnenkamp, MD Department of Anesthesiology and Intensive Care, University Hospital Muenster
  More Information

Publications:
Responsible Party: University Hospital Muenster
ClinicalTrials.gov Identifier: NCT00413127     History of Changes
Other Study ID Numbers: 06-AnIt-06
First Submitted: December 18, 2006
First Posted: December 19, 2006
Last Update Posted: June 26, 2015
Last Verified: June 2015

Keywords provided by University Hospital Muenster:
Systemic lidocaine
peridural lidocaine
perioperative analgesia
inflammation
Anesthesia

Additional relevant MeSH terms:
Lidocaine
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