Perioperative Protective Effects of Lidocaine - Full Text View

Sponsors and Collaborators:	University Hospital Muenster International Anesthesia Research Society (IARS)
Information provided by:	University Hospital Muenster
ClinicalTrials.gov Identifier:	NCT00413127

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 II Phase III

MedlinePlus related topics: Anesthesia

Drug Information available for: Lidocaine

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration

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 2011
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Lidocaine i.v	Drug: lidocaine administration of lidocaine intravenously or epidural or administration of placebo
2: Active Comparator intraoperatively lidocaine epidural postoperatively lidocaine i.v.	Drug: lidocaine administration of lidocaine intravenously or epidural or administration of placebo
3: Active Comparator intraoperatively lidocaine i.v. postoperatively lidocaine epidural	Drug: lidocaine administration of lidocaine intravenously or epidural or administration of placebo
4: Active Comparator lidocaine epidural	Drug: lidocaine administration of lidocaine intravenously or epidural or administration of placebo
5: Placebo Comparator placebo i.v.	Drug: NaCl 0,9% Administration of placebo i.v.

Eligibility

Ages Eligible for Study:	18 Years to 75 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
St. Marienhospital	Recruiting
Vechta, Germany, D-49377
Contact: C Hoenemann, MD +49-4441-99-0
Principal Investigator: C Hoenemann, MD
University Hospital Muenster	Recruiting
Muenster, Germany, D-48129
Contact: K Hahnenkamp, MD +49-251-834-7255
Principal Investigator: K Hahnenkamp, 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:

Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. Epub 2006 Sep 4.

Cooke ED, Bowcock SA, Lloyd MJ, Pilcher MF. Intravenous lignocaine in prevention of deep venous thrombosis after elective hip surgery. Lancet. 1977 Oct 15;2(8042):797-9.

Responsible Party:	Department of Anesthesiology and Intensive Care, University Hospital Muenster ( Hahnenkamp, MD / Principle investigator )
Study ID Numbers:	06-AnIt-06
Study First Received:	December 18, 2006
Last Updated:	November 10, 2008
ClinicalTrials.gov Identifier:	NCT00413127
Health Authority:	Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University Hospital Muenster:

Systemic lidocaine
peridural lidocaine
perioperative analgesia
inflammation
Anesthesia

Study placed in the following topic categories:

Lidocaine
Inflammation

Additional relevant MeSH terms:

Sensory System Agents
Therapeutic Uses
Physiological Effects of Drugs
Central Nervous System Depressants
Anesthetics
Cardiovascular Agents

Anti-Arrhythmia Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Pharmacologic Actions
Anesthetics, Local

ClinicalTrials.gov processed this record on January 14, 2009