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

Tracking Information

First Received Date ^ICMJE

December 18, 2006

Last Updated Date

January 16, 2012

Start Date ^ICMJE

September 2007

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Length of hospital stay

Change History

Complete list of historical versions of study NCT00413127 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Perioperative Protective Effects of Lidocaine

Official Title ^ICMJE

Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Condition ^ICMJE

Elective Surgical Procedure
Colorectal Surgery

Intervention ^ICMJE

Drug: lidocaine
administration of lidocaine intravenously or epidural or administration of placebo
Drug: NaCl 0,9%
Administration of placebo i.v.

Study Arm (s)

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%

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

150

Estimated Completion Date

March 2015

Estimated Primary Completion Date

March 2014 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

elective colorectal surgery

Exclusion Criteria:

ASA > 3
history of anti-inflammatory therapy
history of inflammatory bowl diseases
history of chronic pain treatment

Gender

Both

Ages

18 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: C Hoenemann, MD

+49-4441-99-0

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT00413127

Other Study ID Numbers ^ICMJE

06-AnIt-06

Has Data Monitoring Committee

Responsible Party

University Hospital Muenster

Study Sponsor ^ICMJE

University Hospital Muenster

Collaborators ^ICMJE

International Anesthesia Research Society (IARS)

Investigators ^ICMJE

Study Chair:

K Hahnenkamp, MD

Department of Anesthesiology and Intensive Care, University Hospital Muenster

Information Provided By

University Hospital Muenster

Verification Date

January 2012

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

To Top