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Perioperative Protective Effects of Lidocaine

This study is currently recruiting participants.
Verified January 2012 by University Hospital Muenster
Sponsor:
Collaborator:
International Anesthesia Research Society (IARS)
Information provided by (Responsible Party):
University Hospital Muenster
ClinicalTrials.gov Identifier:
NCT00413127
First received: December 18, 2006
Last updated: January 16, 2012
Last verified: January 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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:

U.S. FDA Resources

Further study details as provided by University Hospital Muenster:

Primary Outcome Measures:
  • length of postoperative hospital stay [ Time Frame: end of hospital stay ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Hyperalgesia perioperative [ Time Frame: postoperative day 2, 4, 8, end of hospital stay and follow-up ] [ Designated as safety issue: No ]
  • Cytokine levels perioperative [ Time Frame: before surgery and 4 hours, 2 and 4 days after surgery ] [ Designated as safety issue: No ]
  • Bowel motility perioperative [ Time Frame: days after surgery ] [ Designated as safety issue: No ]
  • Length of PACU stay [ Time Frame: end of PACU stay ] [ Designated as safety issue: No ]
  • Cognitive function perioperatively [ Time Frame: before surgery, one and four days after surgery, at end of hospital stay and follow-up ] [ Designated as safety issue: No ]
  • Incidence of wound healing disturbances [ Time Frame: within 4 weeks after surgery ] [ Designated as safety issue: No ]
  • Postoperative Analgesia [ Time Frame: until end of hospital stay ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: September 2007
Estimated Study Completion Date: March 2015
Estimated 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

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00413127

Contacts
Contact: C Hoenemann, MD +49-4441-99-0

Locations
Germany
University Hospital Muenster Recruiting
Muenster, Germany, D-48129
Contact: K Hahnenkamp, MD     +49-251-834-7255        
Principal Investigator: K Hahnenkamp, MD            
St. Franziskushospital Muenster Recruiting
Muenster, Germany, D-48145
Contact: Möllmann, Prof. Dr.            
St. Marienhospital Recruiting
Vechta, Germany, D-49377
Contact: C Hoenemann, MD     +49-4441-99-0        
Principal Investigator: C Hoenemann, MD            
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
Study First Received: December 18, 2006
Last Updated: January 16, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Pharmacologic Actions
 Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Arrhythmia Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on June 17, 2013