Skip to main content
OpenTrials
Completed

NCT Number: NCT03044808

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Opioid Use

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Odense Universitetshospital

Odense, 5000, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lidocaine

Drug

Saline

Drug

Primary outcomes

  1. Reduction in morphine consumption

    Time frame: over the first 24 hours

    PCA morphine added to PN (per necessitae) morphine, cumulated

Secondary outcomes

  1. PONV

    Time frame: up to 72 hours

    Postoperative nausea and vomiting - patient is asked

  2. Reduction in morphine consumption

    Time frame: over the first 72hours

    PCA morphine added to PN morphine, cumulated

  3. Use of antiemetics postoperative

    Time frame: first 72 hours

  4. Time to bowel function

    Time frame: first 72 hours

    time to flatus or defecation or function of bowel stoma

  5. time to discharge

    Time frame: up to 72 hours

Sponsors and collaborators

Lead sponsor

Odense University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 7, 2017
Registry last updated
Sep 20, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.