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

Phase 4

Completed

• Conditions: Opioid Use
• Interventions: Drug: Saline; Drug: Lidocaine

• Registration Number: NCT03044808
• Lead Sponsor: Odense University Hospital

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.

Study Timeline

• Study Start: 2016-02-02
• Study First Submitted: 2017-02-03
• Study First Submitted QC: 2017-02-03
• Study First Posted: 2017-02-07
• Primary Completion: 2017-04-19
• Study Completion: 2017-04-19
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-18
• Last Update Posted: 2017-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Saline	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.
Lidocain	Lidocaine	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.

Primary Outcome Measures

Name	Time	Method
Reduction in morphine consumption	over the first 24 hours	PCA morphine added to PN (per necessitae) morphine, cumulated

Secondary Outcome Measures

Name	Time	Method
Use of antiemetics postoperative	first 72 hours
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
Time to bowel function	first 72 hours	time to flatus or defecation or function of bowel stoma
time to discharge	up to 72 hours

Trial Locations

Locations (1)

Odense Universitetshospital; 🇩🇰 Odense, Denmark