Perioperative Protective Effects of Lidocaine

Study Overview
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Brief Summary
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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

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

Conditions
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Elective Surgical Procedure, Colorectal Surgery

Intervention / Treatment
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* Drug: lidocaine
* Drug: NaCl 0,9%


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: elective colorectal surgery Exclusion Criteria: ASA > 3 history of anti-inflammatory therapy history of inflammatory bowl diseases history of chronic pain treatment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Lidocaine i.v | Drug: lidocaine<br>* administration of lidocaine intravenously or epidural or administration of placebo<br>|
| Active Comparator: 2<br>intraoperatively lidocaine epidural postoperatively lidocaine i.v. | Drug: lidocaine<br>* administration of lidocaine intravenously or epidural or administration of placebo<br>|
| Active Comparator: 3<br>intraoperatively lidocaine i.v. postoperatively lidocaine epidural | Drug: lidocaine<br>* administration of lidocaine intravenously or epidural or administration of placebo<br>|
| Active Comparator: 4<br>lidocaine epidural | Drug: lidocaine<br>* administration of lidocaine intravenously or epidural or administration of placebo<br>|
| Placebo Comparator: 5<br>placebo i.v. | Drug: NaCl 0,9%<br>* Administration of placebo i.v.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of postoperative hospital stay |  | end of hospital stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Postoperative Analgesia |  | until end of hospital stay | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Systemic lidocaine, peridural lidocaine, perioperative analgesia, inflammation, Anesthesia