Opioid Use
Conditions
Brief summary
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
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.
Interventions
DRUGLidocaine
DRUGSaline
Sponsors
Odense University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
2 randomized groups, one getting lidocaine and the other getting saline
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in morphine consumption | over the first 24 hours | PCA morphine added to PN (per necessitae) morphine, cumulated |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PONV | up to 72 hours | Postoperative nausea and vomiting - patient is asked |
| Reduction in morphine consumption | over the first 72hours | PCA morphine added to PN morphine, cumulated |
| Use of antiemetics postoperative | first 72 hours | — |
| Time to bowel function | first 72 hours | time to flatus or defecation or function of bowel stoma |
| time to discharge | up to 72 hours | — |
Countries
Denmark
Outcome results
None listed