Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery

Study Overview
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Brief Summary
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Single center double blind randomised controlled trial. 60 subjects. Giving lidocaine IV or saline to patients due to robot assisted colorectal surgery. Primary outcome is cumulative morphine consumption at 24 hours.

Detailed Description
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Prospective double blind randomised controlled trial. The investigators are giving lidocaine IV or saline to 60 patients undergoing robot assisted colorectal surgery. Blinding and randomization is done by the hospital pharmacy. Both groups get otherwise the same treatment and a IV PCA (patient controlled administration) morphine pump for objectivisation of opioid consumption. Other outcome measures are NRS (numerical rating score) pain score, PONV (postoperative nausea and vomiting), use of antiemetics and opioid consumption up to 72 hours.

Official Title
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Randomized Double Blind Prospective Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery

Conditions
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Opioid Use

Intervention / Treatment
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* Drug: Lidocaine
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: all patients due to robotic laparoscopic colorectal surgery, > 18years of age, danish speaking Exclusion Criteria: allergy to lidocain or amid local analgetics, atrioventricular blok, liver- and/or kidney failure, chronic use of opioids or NSAIDS, pregnancy, breastfeeding women, treatment with betablockers, porphyria

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: 2 randomized groups, one getting lidocaine and the other getting saline
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lidocain<br>Patient gets the experimental treatment with IV lidocain 0,5mg/ml, 1,5mg/kg bolus before induction of anesthesia, after that infusion of 1,5mg/kg/h is started and continued until 2 hours after end of surgery. | Drug: Lidocaine<br> <br> |
| Placebo Comparator: Control<br>Patients get the same amount in ml and duration as if it was the experimental arm. Only in this arm it is isotonic saline instead. | Drug: Saline<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in morphine consumption | PCA morphine added to PN (per necessitae) morphine, cumulated | over the first 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PONV | Postoperative nausea and vomiting - patient is asked | up to 72 hours | 
| Reduction in morphine consumption | PCA morphine added to PN morphine, cumulated | over the first 72hours | 
| Use of antiemetics postoperative |  | first 72 hours | 
| Time to bowel function | time to flatus or defecation or function of bowel stoma | first 72 hours | 
| time to discharge |  | up to 72 hours |