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

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ClinicalTrials.gov Identifier: NCT03044808
Recruitment Status : Completed
First Posted : February 7, 2017
Last Update Posted : September 20, 2017
Sponsor:
Information provided by (Responsible Party):
Jan Herzog, 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.

Condition or disease Intervention/treatment Phase
Opioid Use Drug: Lidocaine Drug: Saline Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 2 randomized groups, one getting lidocaine and the other getting saline
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes 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.
Primary Purpose: Treatment
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
Actual Study Start Date : February 2, 2016
Actual Primary Completion Date : April 19, 2017
Actual Study Completion Date : April 19, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bowel Movement

Arm Intervention/treatment
Experimental: 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.
Drug: Lidocaine
Placebo Comparator: 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.
Drug: Saline



Primary Outcome Measures :
  1. Reduction in morphine consumption [ Time Frame: over the first 24 hours ]
    PCA morphine added to PN (per necessitae) morphine, cumulated


Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03044808


Locations
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Denmark
Odense Universitetshospital
Odense, Denmark, 5000
Sponsors and Collaborators
Odense University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jan Herzog, M.D., Odense University Hospital
ClinicalTrials.gov Identifier: NCT03044808    
Other Study ID Numbers: 13.024
2014-003466-25 ( EudraCT Number )
First Posted: February 7, 2017    Key Record Dates
Last Update Posted: September 20, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Lidocaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action