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

NCT ID: NCT03044808

Last Updated: 2017-09-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-02

Study Completion Date

2017-04-19

Brief Summary

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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

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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.

Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

2 randomized groups, one getting lidocaine and the other getting saline
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors
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.

Study Groups

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Lidocain

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.

Group Type EXPERIMENTAL

Lidocaine

Intervention Type DRUG

Control

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.

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

Interventions

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Lidocaine

Intervention Type DRUG

Saline

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Odense University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jan Herzog

M.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Odense Universitetshospital

Odense, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type DERIVED
PMID: 31908254 (View on PubMed)

Other Identifiers

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2014-003466-25

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

13.024

Identifier Type: -

Identifier Source: org_study_id