Perioperative Protective Effects of Lidocaine

This study has been terminated.
(Less patients than expected for inclusion, therefore patient recruitment is to low)
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: June 25, 2015
Last verified: June 2015
  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:


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 ]

Enrollment: 78
Study Start Date: September 2007
Study Completion Date: March 2015
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00413127

Locations
Germany
St. Franziskushospital Muenster
Muenster, Germany, D-48145
University Hospital Muenster
Muenster, Germany, D-48129
St. Marienhospital
Vechta, Germany, D-49377
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: June 25, 2015
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
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on July 27, 2015