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Perioperative Protective Effects of Lidocaine

This study is currently recruiting participants. (see Contacts and Locations)
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

December 18, 2006
January 16, 2012
September 2007
March 2014   (final data collection date for primary outcome measure)
length of postoperative hospital stay [ Time Frame: end of hospital stay ] [ Designated as safety issue: No ]
Length of hospital stay
Complete list of historical versions of study NCT00413127 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Hyperalgesia perioperative
  • Hyperalgesia at end of hospital stay
  • Hyperalgesia at 6 months postoperative
  • Cytokine levels perioperative
  • Cytokine levels at end of hospital stay
  • Bowel motily perioperative
  • Length of PACU stay
  • aldrete score
Not Provided
Not Provided
 
Perioperative Protective Effects of Lidocaine
Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration

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

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Elective Surgical Procedure
  • Colorectal Surgery
  • Drug: lidocaine
    administration of lidocaine intravenously or epidural or administration of placebo
  • Drug: NaCl 0,9%
    Administration of placebo i.v.
  • Experimental: 1
    Lidocaine i.v
    Intervention: Drug: lidocaine
  • Active Comparator: 2
    intraoperatively lidocaine epidural postoperatively lidocaine i.v.
    Intervention: Drug: lidocaine
  • Active Comparator: 3
    intraoperatively lidocaine i.v. postoperatively lidocaine epidural
    Intervention: Drug: lidocaine
  • Active Comparator: 4
    lidocaine epidural
    Intervention: Drug: lidocaine
  • Placebo Comparator: 5
    placebo i.v.
    Intervention: Drug: NaCl 0,9%

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
March 2015
March 2014   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • elective colorectal surgery

Exclusion Criteria:

  • ASA > 3
  • history of anti-inflammatory therapy
  • history of inflammatory bowl diseases
  • history of chronic pain treatment
Both
18 Years to 85 Years
No
Contact: C Hoenemann, MD +49-4441-99-0
Germany
 
NCT00413127
06-AnIt-06
No
University Hospital Muenster
University Hospital Muenster
International Anesthesia Research Society (IARS)
Study Chair: K Hahnenkamp, MD Department of Anesthesiology and Intensive Care, University Hospital Muenster
University Hospital Muenster
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP