Perioperative Protective Effects of Lidocaine

Colorectal Surgery Clinical Trial

Official title:

Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00413127
• Other study ID #: 06-AnIt-06
• 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

• Colorectal Surgery
• Elective Surgical Procedure

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