NCT03095404

Brief Summary

Currently, there are no studies that address the optimum dosage of lidocaine for surgical procedures. Lidocaine is a local anesthetic that is injected to induce anesthesia. Improper or inefficient pain treatment can lead to longer hospital stay, and adverse side effects such as nausea and vomiting. Opioids are the primary drug to treat moderate to severe pain, but are also responsible for nausea and other side effects. Lidocaine has shown to have opioid sparing effects; meaning less opioid use is necessary for pain relief. In this study, we will conduct a clinical trial to assess the difference between different lidocaine dosage schedules to determine the optimum dosage that brings maximum pain relief while minimizing adverse side effects and patient stay. A large benefit in using lidocaine is its documented opioid sparing which allows for minimal drug treatment.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2021

Shorter than P25 for early_phase_1

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 21, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 29, 2017

Completed
4.4 years until next milestone

Study Start

First participant enrolled

September 1, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
Last Updated

October 8, 2021

Status Verified

October 1, 2021

Enrollment Period

4 months

First QC Date

February 21, 2017

Last Update Submit

October 1, 2021

Conditions

Bariatric Surgery Candidate

Outcome Measures

Primary Outcomes (1)

  • Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight

    Feasibility and safety of different dosing schedules

    5 days

Secondary Outcomes (8)

  • Amount of intraoperative narcotics used post-surgery

    1 day

  • Pain scores

    2 days

  • Enhancement of gastrointestinal recovery

    24 hours

  • Post-operative nausea and vomiting

    24 hours

  • Patient satisfaction

    1 day

  • +3 more secondary outcomes

Study Arms (2)

Low Dose Lidocaine

EXPERIMENTAL

60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula

Drug: Low Dose Lidocaine

High Dose Lidocaine

EXPERIMENTAL

60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula

Drug: High Dose Lidocaine

Interventions

Low Dose LidocaineDRUG

60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula

Also known as: Lidocaine 1% Injectable Solution
Low Dose Lidocaine
High Dose LidocaineDRUG

60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula

Also known as: Lidocaine 2% Injectable Solution
High Dose Lidocaine

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Bariatric patients 18 years or older undergoing major bowel surgery
  • Patient capable to complete informed consent

You may not qualify if:

  • Pediatric population
  • Inability to complete informed consent
  • Patient refusal
  • Chronic aspirin or NSAID intake
  • Known allergy to aspirin and/or NSAIDs, or lidocaine
  • History of bronchial asthma requiring intubation
  • Peptic ulceration
  • Coagulopathy
  • Renal insufficiency
  • Opioid abuse
  • Pregnancy
  • Conversion from laparoscopic to open surgery.
  • Other relative contraindications for lidocaine; unstable CAD, Recent MI, Heart Failure, Heart Block, Electrolyte Disturbances, Liver Disease, Cardiac Dysrhythmias, and Seizure Disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.

    PMID: 22250276BACKGROUND

  • Han PY, Duffull SB, Kirkpatrick CM, Green B. Dosing in obesity: a simple solution to a big problem. Clin Pharmacol Ther. 2007 Nov;82(5):505-8. doi: 10.1038/sj.clpt.6100381.

    PMID: 17952107BACKGROUND

MeSH Terms

Interventions

Lidocaine

Intervention Hierarchy (Ancestors)

AcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Greg Peachey, MD

    McMaster University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 21, 2017

First Posted

March 29, 2017

Study Start

September 1, 2021

Primary Completion

December 31, 2021

Study Completion

February 28, 2022

Last Updated

October 8, 2021

Record last verified: 2021-10