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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003466-25 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lidocain | Experimental | 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. |
|
| Control | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lidocaine | Drug |
| ||
| Saline |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction in morphine consumption | PCA morphine added to PN (per necessitae) morphine, cumulated | over the first 24 hours |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense Universitetshospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31908254 | Derived | Herzog J, Schou M, Jensen KM, Lauridsen JT, Jensen AG. A randomised controlled trial of lidocaine infusion on post-operative opioid consumption in patients undergoing robotic colorectal surgery. Dan Med J. 2020 Jan;67(1):A06190342. |
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| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
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2 randomized groups, one getting lidocaine and the other getting saline
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Pharmacy provides the research medicine, it is not possible to see a difference. The envelopes are "encrypted". The randomization will only be broken in the end.
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| 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 |
| Aniline Compounds |
| D000588 | Amines |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |