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Clinical Trials/NCT00413127
NCT00413127
Terminated
Phase 2

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

University Hospital Muenster3 sites in 1 country78 target enrollmentSeptember 2007
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ConditionsElective Surgical ProcedureColorectal Surgery
InterventionslidocaineNaCl 0,9%
DrugslidocaineNaCl 0,9%

Overview

Phase
Phase 2
Intervention
lidocaine
Conditions
Elective Surgical Procedure
Sponsor
University Hospital Muenster
Enrollment
78
Locations
3
Primary Endpoint
length of postoperative hospital stay
Status
Terminated
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSitesSimilar Trials

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2007
End Date
March 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
University Hospital Muenster
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • •elective colorectal surgery

Exclusion Criteria

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

Arms & Interventions

1

Lidocaine i.v

Intervention: lidocaine

2

intraoperatively lidocaine epidural postoperatively lidocaine i.v.

Intervention: lidocaine

3

intraoperatively lidocaine i.v. postoperatively lidocaine epidural

Intervention: lidocaine

4

lidocaine epidural

Intervention: lidocaine

5

placebo i.v.

Intervention: NaCl 0,9%

Outcomes

Primary Outcomes

length of postoperative hospital stay

Time Frame: end of hospital stay

Secondary Outcomes

  • 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)

Study Sites (3)

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