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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
December 18, 2006
December 19, 2006
June 26, 2015
September 2007
March 2014   (Final data collection date for primary outcome measure)
length of postoperative hospital stay [ Time Frame: end of hospital stay ]
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 ]
  • 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 ]
  • 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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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.
 
Terminated
78
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
Sexes Eligible for Study: All
18 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
 
NCT00413127
06-AnIt-06
No
Not Provided
Not Provided
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
June 2015

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