Perioperative Protective Effects of Lidocaine

Phase 2

Terminated

• Conditions: Elective Surgical Procedure; Colorectal Surgery
• Interventions: Drug: lidocaine; Drug: NaCl 0,9%

• Registration Number: NCT00413127
• Lead Sponsor: University Hospital Muenster

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-12-18
• Study First Submitted QC: 2006-12-18
• Study First Posted: 2006-12-19
• Study Start: 2007-09
• Primary Completion: 2014-03
• Study Completion: 2015-03
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-25
• Last Update Posted: 2015-06-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 78

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	lidocaine	intraoperatively lidocaine i.v. postoperatively lidocaine epidural
4	lidocaine	lidocaine epidural
5	NaCl 0,9%	placebo i.v.
1	lidocaine	Lidocaine i.v
2	lidocaine	intraoperatively lidocaine epidural postoperatively lidocaine i.v.

Primary Outcome Measures

Name	Time	Method
length of postoperative hospital stay	end of hospital stay

Secondary Outcome Measures

Name	Time	Method
Postoperative Analgesia	until end of hospital stay
Hyperalgesia perioperative	postoperative day 2, 4, 8, end of hospital stay and follow-up
Cytokine levels perioperative	before surgery and 4 hours, 2 and 4 days after surgery
Bowel motility perioperative	days after surgery
Length of PACU stay	end of PACU stay
Cognitive function perioperatively	before surgery, one and four days after surgery, at end of hospital stay and follow-up
Incidence of wound healing disturbances	within 4 weeks after surgery

Trial Locations

Locations (3)

University Hospital Muenster; 🇩🇪 Muenster, Germany

St. Franziskushospital Muenster; 🇩🇪 Muenster, Germany

St. Marienhospital; 🇩🇪 Vechta, Germany