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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00413127
Other study ID # 06-AnIt-06
Secondary ID
Status Terminated
Phase Phase 2/Phase 3
First received December 18, 2006
Last updated June 25, 2015
Start date September 2007
Est. completion date March 2015

Study information

Verified date June 2015
Source University Hospital Muenster
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Terminated
Enrollment 78
Est. completion date March 2015
Est. primary completion date March 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 85 Years
Eligibility 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 Design

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


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Germany St. Franziskushospital Muenster Muenster
Germany University Hospital Muenster Muenster
Germany St. Marienhospital Vechta

Sponsors (2)

Lead Sponsor Collaborator
University Hospital Muenster International Anesthesia Research Society (IARS)

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary length of postoperative hospital stay end of hospital stay No
Secondary Hyperalgesia perioperative postoperative day 2, 4, 8, end of hospital stay and follow-up No
Secondary Cytokine levels perioperative before surgery and 4 hours, 2 and 4 days after surgery No
Secondary Bowel motility perioperative days after surgery No
Secondary Length of PACU stay end of PACU stay No
Secondary Cognitive function perioperatively before surgery, one and four days after surgery, at end of hospital stay and follow-up No
Secondary Incidence of wound healing disturbances within 4 weeks after surgery No
Secondary Postoperative Analgesia until end of hospital stay No
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