Perioperative Protective Effects of Lidocaine

NCT ID: NCT00413127

Last Updated: 2015-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2015-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Elective Surgical Procedure Colorectal Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Lidocaine i.v

Group Type EXPERIMENTAL

lidocaine

Intervention Type DRUG

administration of lidocaine intravenously or epidural or administration of placebo

2

intraoperatively lidocaine epidural postoperatively lidocaine i.v.

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

administration of lidocaine intravenously or epidural or administration of placebo

3

intraoperatively lidocaine i.v. postoperatively lidocaine epidural

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

administration of lidocaine intravenously or epidural or administration of placebo

4

lidocaine epidural

Group Type ACTIVE_COMPARATOR

lidocaine

Intervention Type DRUG

administration of lidocaine intravenously or epidural or administration of placebo

5

placebo i.v.

Group Type PLACEBO_COMPARATOR

NaCl 0,9%

Intervention Type DRUG

Administration of placebo i.v.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

lidocaine

administration of lidocaine intravenously or epidural or administration of placebo

Intervention Type DRUG

NaCl 0,9%

Administration of placebo i.v.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* elective colorectal surgery

Exclusion Criteria

* ASA \> 3
* history of anti-inflammatory therapy
* history of inflammatory bowl diseases
* history of chronic pain treatment
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

International Anesthesia Research Society (IARS)

OTHER

Sponsor Role collaborator

University Hospital Muenster

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

K Hahnenkamp, MD

Role: STUDY_CHAIR

Department of Anesthesiology and Intensive Care, University Hospital Muenster

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University Hospital Muenster

Münster, , Germany

Site Status

St. Franziskushospital Muenster

Münster, , Germany

Site Status

St. Marienhospital

Vechta, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

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. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.

Reference Type BACKGROUND
PMID: 16952918 (View on PubMed)

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. doi: 10.1016/s0140-6736(77)90727-9.

Reference Type BACKGROUND
PMID: 71604 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

06-AnIt-06

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.