Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery
Primary Purpose
Opioid Use
Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Lidocaine
Saline
Sponsored by
About this trial
This is an interventional treatment trial for Opioid Use
Eligibility Criteria
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
Sites / Locations
- Odense Universitetshospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Lidocain
Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Reduction in morphine consumption
PCA morphine added to PN (per necessitae) morphine, cumulated
Secondary Outcome Measures
PONV
Postoperative nausea and vomiting - patient is asked
Reduction in morphine consumption
PCA morphine added to PN morphine, cumulated
Use of antiemetics postoperative
Time to bowel function
time to flatus or defecation or function of bowel stoma
time to discharge
Full Information
NCT ID
NCT03044808
First Posted
February 3, 2017
Last Updated
September 18, 2017
Sponsor
Odense University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03044808
Brief Title
Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery
Official Title
Randomized Double Blind Prospective Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
February 2, 2016 (Actual)
Primary Completion Date
April 19, 2017 (Actual)
Study Completion Date
April 19, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Odense University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
2 randomized groups, one getting lidocaine and the other getting saline
Masking
ParticipantCare ProviderInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Lidocain
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Type
Drug
Intervention Name(s)
Saline
Primary Outcome Measure Information:
Title
Reduction in morphine consumption
Description
PCA morphine added to PN (per necessitae) morphine, cumulated
Time Frame
over the first 24 hours
Secondary Outcome Measure Information:
Title
PONV
Description
Postoperative nausea and vomiting - patient is asked
Time Frame
up to 72 hours
Title
Reduction in morphine consumption
Description
PCA morphine added to PN morphine, cumulated
Time Frame
over the first 72hours
Title
Use of antiemetics postoperative
Time Frame
first 72 hours
Title
Time to bowel function
Description
time to flatus or defecation or function of bowel stoma
Time Frame
first 72 hours
Title
time to discharge
Time Frame
up to 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
31908254
Citation
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.
Results Reference
derived
Learn more about this trial
Investigation of the Effect of Intravenous Lidocaine Infusion on Postoperative Pain Treatment and Bowel Function in Robotic Bowel Surgery
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