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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03095404
Recruitment Status : Not yet recruiting
First Posted : March 29, 2017
Last Update Posted : March 6, 2019
Sponsor:
Collaborator:
St. Joseph's Healthcare Hamilton
Information provided by (Responsible Party):
McMaster University

Tracking Information
First Submitted Date  ICMJE February 21, 2017
First Posted Date  ICMJE March 29, 2017
Last Update Posted Date March 6, 2019
Estimated Study Start Date  ICMJE September 2020
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
Evaluation of an intravenous lidocaine dosing schedule using 1mg/kg or 2mg/kg adjusted body weight [ Time Frame: 5 days ]
Feasibility and safety of different dosing schedules
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 23, 2017)
  • Amount of intraoperative narcotics used post-surgery [ Time Frame: 1 day ]
    Morphine equivalents in mg of narcotic used
  • Pain scores [ Time Frame: 2 days ]
    Using visual analogue scale
  • Enhancement of gastrointestinal recovery [ Time Frame: 24 hours ]
    Time to first flatus and/or bowel movement and incidence of paralytic ileus
  • Post-operative nausea and vomiting [ Time Frame: 24 hours ]
    Using 0-4 nausea and vomiting scale
  • Patient satisfaction [ Time Frame: 1 day ]
    Using American Pain society outcome questionnaire
  • Time of rescue analgesia [ Time Frame: 24 hours ]
    Time in minutes for participant to request for extra pain medication
  • Length of stay in recovery room [ Time Frame: 1 day ]
    Time in hours for recovery room stay
  • Length of hospital stay [ Time Frame: 5 days ]
    Number of days in hospital
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
Official Title  ICMJE Optimum Dosage of Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Condition  ICMJE Bariatric Surgery Candidate
Intervention  ICMJE
  • Drug: Low Dose Lidocaine
    60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
    Other Name: Lidocaine 1% Injectable Solution
  • Drug: High Dose Lidocaine
    60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
    Other Name: Lidocaine 2% Injectable Solution
Study Arms  ICMJE
  • Experimental: Low Dose Lidocaine
    60 cc syringe with 2 vials of 1% lidocaine (40cc's) low dose solution using adjusted body weight formula
    Intervention: Drug: Low Dose Lidocaine
  • Experimental: High Dose Lidocaine
    60 cc syringe with 2 vials of 2% lidocaine (40 cc's) high dose solution using adjusted body weight formula
    Intervention: Drug: High Dose Lidocaine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: March 23, 2017)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE February 28, 2022
Estimated Primary Completion Date December 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Greg Peachey, MD 905-522-1155 ext 33853 gregpeachey@cogeco.ca
Contact: Toni Tidy, HBSc, CCRA 905-525-9140 ext 21737 tonitidy@mcmaster.ca
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03095404
Other Study ID Numbers  ICMJE 2198
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party McMaster University
Study Sponsor  ICMJE McMaster University
Collaborators  ICMJE St. Joseph's Healthcare Hamilton
Investigators  ICMJE
Principal Investigator: Greg Peachey, MD McMaster University
PRS Account McMaster University
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP