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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

About this trial

This is an interventional treatment trial for Opioid Use

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

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

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

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

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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