Perioperative Protective Effects of Lidocaine

June 25, 2015 updated by: University Hospital Muenster

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

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

78

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Muenster, Germany, D-48129
        • University Hospital Muenster
      • Muenster, Germany, D-48145
        • St. Franziskushospital Muenster
      • Vechta, Germany, D-49377
        • St. Marienhospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • elective colorectal surgery

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
length of postoperative hospital stay
Time Frame: end of hospital stay
end of hospital stay

Secondary Outcome Measures

Outcome Measure
Time Frame
Hyperalgesia perioperative
Time Frame: postoperative day 2, 4, 8, end of hospital stay and follow-up
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
before surgery and 4 hours, 2 and 4 days after surgery
Bowel motility perioperative
Time Frame: days after surgery
days after surgery
Length of PACU stay
Time Frame: end of PACU stay
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
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
within 4 weeks after surgery
Postoperative Analgesia
Time Frame: until end of hospital stay
until end of hospital stay

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Muenster

Collaborators

International Anesthesia Research Society (IARS)

Investigators

  • Study Chair: K Hahnenkamp, MD, Department of Anesthesiology and Intensive Care, University Hospital Muenster

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Actual)

March 1, 2014

Study Completion (Actual)

March 1, 2015

Study Registration Dates

First Submitted

December 18, 2006

First Submitted That Met QC Criteria

December 18, 2006

First Posted (Estimate)

December 19, 2006

Study Record Updates

Last Update Posted (Estimate)

June 26, 2015

Last Update Submitted That Met QC Criteria

June 25, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 06-AnIt-06

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Colorectal Surgery

Clinical Trials on lidocaine

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Rwanda

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe