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Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery

Primary Purpose

Bariatric Surgery Candidate

Status
Withdrawn
Phase
Early Phase 1
Locations
Study Type
Interventional
Intervention
Low Dose Lidocaine
High Dose Lidocaine
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Bariatric Surgery Candidate

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Low Dose Lidocaine

    High Dose Lidocaine

    Arm Description

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

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

    Outcomes

    Primary Outcome Measures

    Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight
    Feasibility and safety of different dosing schedules

    Secondary Outcome Measures

    Amount of intraoperative narcotics used post-surgery
    Morphine equivalents in mg of narcotic used
    Pain scores
    Using visual analogue scale
    Enhancement of gastrointestinal recovery
    Time to first flatus and/or bowel movement and incidence of paralytic ileus
    Post-operative nausea and vomiting
    Using 0-4 nausea and vomiting scale
    Patient satisfaction
    Using American Pain society outcome questionnaire
    Time of rescue analgesia
    Time in minutes for participant to request for extra pain medication
    Length of stay in recovery room
    Time in hours for recovery room stay
    Length of hospital stay
    Number of days in hospital

    Full Information

    First Posted
    February 21, 2017
    Last Updated
    October 1, 2021
    Sponsor
    McMaster University
    Collaborators
    St. Joseph's Healthcare Hamilton
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03095404
    Brief Title
    Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
    Official Title
    Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2021
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    No funding available.
    Study Start Date
    September 2021 (Anticipated)
    Primary Completion Date
    December 31, 2021 (Anticipated)
    Study Completion Date
    February 28, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University
    Collaborators
    St. Joseph's Healthcare Hamilton

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    Detailed Description
    Lidocaine was first discovered from systematic investigations at the Institute of Chemistry at Stockholm. In the early 1940s, Nils Lofgren discovered lidocaine as a potent anesthetic, initially labelled LL30. It was first clinically tested in 1994, and stood up to appraisal as a reliable and highly efficient local anesthetic. One systematic review found that, depending on the duration of the infusion of lidocaine, significantly different pain ratings resulted. Similarly, a review found low to moderate evidence for an effect of intravenous lidocaine on pain at rest as one of the major predefined outcomes. Interestingly, this was true for a large variation between the bolus doses (1 to 3mg/kg) and continuous infusion regimes (1.5 to 5 mg/kg/h). The variation of doses impacted pain; early and intermediate, postoperative ileus, time to first flatus, and time to first bowel movements/sounds. One study based all medications in the protocol on the dosing body weight [ideal body weight (IBW) + 0.4 x (actual body weight-IBW). Besides an important improvement in overall quality of recovery, subjects had an improvement in the physical comfort, pain, and physical independence subcomponents of the quality of recovery score. Additionally, there was an opioid sparing effect observed in patients undergoing laparoscopic bariatric surgery, making it especially critical due to the limited respiratory reserve of the bariatric population. Another study assigned subjects in the experimental group to an IV infusion of 2mg/kg per hour of lidocaine, maintained 15 to 30 minutes before skin closure. The study found similar positive effects, improving postoperative analgesia, reducing postoperative opioid requirements, and accelerating the return of the first flatus. Specifically, the investigation found results similar to previous investigations with longer infusion times across a variety of surgical procedures. Based on the above, there is a call for further research evaluating the optimum dosage of lidocaine infusion in bariatric populations undergoing major surgery. Not only are there a wide variety of positive effects of lidocaine that need to be investigated, but there is a need for precision and sensitivity of dose regimes in a bariatric population susceptible to adverse effects. It is therefore of interest to find an optimal dosage schedule in order to provide anesthesiologists with a standard which maximizes opioid sparing effects, whilst minimizing patient pain, hospital stay, as well as nausea and vomiting. Given the complexity of this proposed randomized-controlled trial, as well as time and financial limitations, a pilot study was deemed necessary to find out the feasibility and safety of comparing different dosing schedules, rate of patient recruitment, funding necessities, and needs of additional personnel.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bariatric Surgery Candidate

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Early Phase 1
    Interventional Study Model
    Single Group Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Low Dose Lidocaine
    Arm Type
    Experimental
    Arm Description
    60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
    Arm Title
    High Dose Lidocaine
    Arm Type
    Experimental
    Arm Description
    60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
    Intervention Type
    Drug
    Intervention Name(s)
    Low Dose Lidocaine
    Other Intervention Name(s)
    Lidocaine 1% Injectable Solution
    Intervention Description
    60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
    Intervention Type
    Drug
    Intervention Name(s)
    High Dose Lidocaine
    Other Intervention Name(s)
    Lidocaine 2% Injectable Solution
    Intervention Description
    60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
    Primary Outcome Measure Information:
    Title
    Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight
    Description
    Feasibility and safety of different dosing schedules
    Time Frame
    5 days
    Secondary Outcome Measure Information:
    Title
    Amount of intraoperative narcotics used post-surgery
    Description
    Morphine equivalents in mg of narcotic used
    Time Frame
    1 day
    Title
    Pain scores
    Description
    Using visual analogue scale
    Time Frame
    2 days
    Title
    Enhancement of gastrointestinal recovery
    Description
    Time to first flatus and/or bowel movement and incidence of paralytic ileus
    Time Frame
    24 hours
    Title
    Post-operative nausea and vomiting
    Description
    Using 0-4 nausea and vomiting scale
    Time Frame
    24 hours
    Title
    Patient satisfaction
    Description
    Using American Pain society outcome questionnaire
    Time Frame
    1 day
    Title
    Time of rescue analgesia
    Description
    Time in minutes for participant to request for extra pain medication
    Time Frame
    24 hours
    Title
    Length of stay in recovery room
    Description
    Time in hours for recovery room stay
    Time Frame
    1 day
    Title
    Length of hospital stay
    Description
    Number of days in hospital
    Time Frame
    5 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Bariatric patients 18 years or older undergoing major bowel surgery Patient capable to complete informed consent Exclusion Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Greg Peachey, MD
    Organizational Affiliation
    McMaster University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    Citations:
    PubMed Identifier
    22250276
    Citation
    Aubrun F, Mazoit JX, Riou B. Postoperative intravenous morphine titration. Br J Anaesth. 2012 Feb;108(2):193-201. doi: 10.1093/bja/aer458.
    Results Reference
    background
    PubMed Identifier
    17952107
    Citation
    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.
    Results Reference
    background

    Learn more about this trial

    Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery

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