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

NCT03044808 | Completed Phase 4 DMC

• 2 other identifiers: 13.0242014-003466-25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (1)

• Reduction in morphine consumption

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

  over the first 24 hours

Secondary Outcomes (5)

• PONV

  up to 72 hours

• Reduction in morphine consumption

  over the first 72hours

• Use of antiemetics postoperative

  first 72 hours

• Time to bowel function

  first 72 hours

• time to discharge

  up to 72 hours

Study Arms (2)

Lidocain

EXPERIMENTAL

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

Control

PLACEBO COMPARATOR

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

Interventions

Lidocaine DRUG

Lidocain

Saline DRUG

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all patients due to robotic laparoscopic colorectal surgery, \> 18years of age, danish speaking

You may not qualify if:

• 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

Sponsors & Collaborators

• Odense University Hospital: lead

Study Sites (1)

Odense Universitetshospital

Odense, 5000, Denmark

Location

Related Publications (1)

• 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.

  PMID: 31908254 DERIVED

MeSH Terms

Interventions

Lidocaine; Sodium Chloride

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: 2 randomized groups, one getting lidocaine and the other getting saline

Study Record Dates

• First Submitted: February 3, 2017
• First Posted: February 7, 2017
• Study Start: February 2, 2016
• Primary Completion: April 19, 2017
• Study Completion: April 19, 2017
• Last Updated: September 20, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)